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Yang J, Gao X, Cheng X, Fu R, Xie H, Zhang S, Liang Z, Chen X, Yu Q, Wang C. Impact of Intermittent Theta Burst Stimulation on Pain Relief and Brain Connectivity in Chronic Low Back Pain. Eur J Pain 2025; 29:e70033. [PMID: 40321017 PMCID: PMC12050991 DOI: 10.1002/ejp.70033] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2024] [Revised: 04/19/2025] [Accepted: 04/23/2025] [Indexed: 05/08/2025]
Abstract
BACKGROUND This randomised clinical trial investigated the effect of intermittent theta burst stimulation (iTBS) over the dorsolateral prefrontal cortex (DLPFC) on pain alleviation in patients with chronic low back pain (CLBP) and its underlying mechanisms. METHODS Forty CLBP patients were randomly assigned to receive either active or sham iTBS combined with core stability exercise. Pain assessments were completed before and after the intervention. Eleven patients from each group underwent resting-state functional magnetic resonance imaging scans pre- and post-intervention to analyse DLPFC activation and connectivity with other brain regions. RESULTS The active iTBS group had a greater pain reduction than the sham group (p = 0.05, 95% CI: -0.009 to 1.109). In the active and sham groups, 80% (16/20) and 40% (8/20) reached the minimal clinically important difference, respectively, with a number needed to treat of 2.5. For the Fear-Avoidance Beliefs Questionnaire, there was a significant difference between the two groups (p = 0.011, r = 0.40). The active iTBS group showed a significantly enhanced functional connectivity between the left DLPFC and the right cerebellum, as well as both occipital gyri (voxel-level, p < 0.001; cluster-level familywise error rate, p < 0.01). Spearman's correlation analysis showed a significant negative correlation between Numerical Rating Scale and the FC of the left DLPFC and the right cerebellum (rho = -0.55, p = 0.008), the right (rho = -0.439, p = 0.01), and left occipital gyri (rho = -0.45, p = 0.034). CONCLUSION iTBS may alleviate pain in CLBP patients by enhancing DLPFC connectivity with the cerebellum and occipital gyrus. SIGNIFICANCE This study showed a facilitatory effect of iTBS on alleviating CLBP, which might be modulated by brain functional connectivity. Trial Registration Chinese Clinical Trial Registry: ChiCTR2200064899.
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Affiliation(s)
- Jiajia Yang
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Xiaoyu Gao
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Xue Cheng
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Ruochen Fu
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Hao Xie
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Siyun Zhang
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Zhenwen Liang
- Department of Rehabilitation MedicineThe First Affiliated Hospital of Jinan UniversityGuangzhouChina
| | - Xi Chen
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Qiuhua Yu
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
| | - Chuhuai Wang
- Department of Rehabilitation Medicine, The First Affiliated HospitalSun Yat‐Sen UniversityGuangzhouChina
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Muthu S, Vadranapu S. Variations in quantifying patient reported outcome measures to estimate treatment effect. World J Methodol 2025; 15:97078. [DOI: 10.5662/wjm.v15.i2.97078] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/22/2024] [Revised: 10/13/2024] [Accepted: 11/06/2024] [Indexed: 11/27/2024] Open
Abstract
In the practice of healthcare, patient-reported outcomes (PROs) and PRO measures (PROMs) are used as an attempt to observe the changes in complex clinical situations. They guide us in making decisions based on the evidence regarding patient care by recording the change in outcomes for a particular treatment to a given condition and finally to understand whether a patient will benefit from a particular treatment and to quantify the treatment effect. For any PROM to be usable in health care, we need it to be reliable, encapsulating the points of interest with the potential to detect any real change. Using structured outcome measures routinely in clinical practice helps the physician to understand the functional limitation of a patient that would otherwise not be clear in an office interview, and this allows the physician and patient to have a meaningful conversation as well as a customized plan for each patient. Having mentioned the rationale and the benefits of PROMs, understanding the quantification process is crucial before embarking on management decisions. A better interpretation of change needs to identify the treatment effect based on clinical relevance for a given condition. There are a multiple set of measurement indices to serve this effect and most of them are used interchangeably without clear demarcation on their differences. This article details the various quantification metrics used to evaluate the treatment effect using PROMs, their limitations and the scope of usage and implementation in clinical practice.
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Affiliation(s)
- Sathish Muthu
- Department of Orthopaedics, Orthopaedic Research Group, Coimbatore 641045, Tamil Nadu, India
- Department of Orthopaedics, Government Medical College, Karur 639004, Tamil Nadu, India
- Department of Biotechnology, Karpagam Academy of Higher Education, Coimbatore 641021, Tamil Nadu, India
| | - Srujun Vadranapu
- Department of Orthopaedics, Royal Care Super Speciality Hospital, Coimbatore 641062, Tamil Nadu, India
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Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with lumbar radiofrequency ablation for chronic pain (RAPID). INTERVENTIONAL PAIN MEDICINE 2025; 4:100576. [PMID: 40342788 PMCID: PMC12060452 DOI: 10.1016/j.inpm.2025.100576] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/17/2025] [Revised: 03/17/2025] [Accepted: 03/17/2025] [Indexed: 05/11/2025]
Abstract
Background Lumbar facet joint syndrome (LFJS) is one of most common forms of chronic low back pain. Despite several decades of real-world use and a plethora of published studies, debate still exists regarding the effectiveness of Radiofrequency Ablation (RFA) as a therapy in LFJS-diagnosed patients. Objective Here, we sought to evaluate real-world clinical outcomes in RFA-treated patients with chronic lumbar facetogenic pain participating in one of the largest studies of its kind published to date. Methods The RAPID study (Clinicaltrials.gov identifier: NCT04673032) is an international, multicenter, prospective study of patients using a commercially-available radiofrequency ablation system for the treatment of chronic pain, provided per standard of care. Patients were assessed at pre-specified study follow-up visits (1-, 3-. 6-, 12-, and 24-months post-index procedure). Key clinical endpoint measures collected and evaluated include NRS (pain score), Oswestry Disability Index (functional disability, ODI), EQ-5D-5L (quality-of-life), and Patient Global Impression of Change (PGIC). Results To date, 193 patients have been enrolled in this lumbar facetogenic pain patient cohort. Evaluation of pain relief amongst patients assessed out to 24-months demonstrated a mean NRS score of 3.4 (baseline NRS: 6.6, p < 0.0001). Consistent functional improvement out to 24-months was observed per an 8.6-point mean ODI score reduction (baseline ODI: 38.0, p < 0.0001). Following RFA treatment at 1-month and out to 24-months, 77.0% and 79.0% of patients were observed to be treatment responders (i.e., ≥50% pain relief), respectively. Enhanced levels in measures of quality-of-life (EQ-5D-5L) and self-reported health-related change (PGIC) were also consistently noted. Conclusions Clinically meaningful and durable improvements in pain relief, functional disability, quality-of-life and treatment satisfaction were observed across all RAPID study follow-up visits. The results of the RAPID study provide for the potential clinical outcomes amongst selected patients with lumbar facetogenic pain within the real-world clinical setting.
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Affiliation(s)
| | | | | | | | - Maaz Iqbal
- Elite Pain and Spine Institute, Mesa, AZ, USA
| | - Binit Shah
- Carolinas Pain Center, Huntersville, NC, USA
| | | | | | | | - Erik Shaw
- Shepherd Center, Shepherd Pain Institute, Atlanta, GA, USA
| | - Sherri Haas
- Twin Cities Pain Clinic & Surgery Center, Edina, MN, USA
| | - Rajat Sekhar
- St. Vincent's Medical Center, Bridgeport, CT, USA
| | - Ann Pan
- Boston Scientific Neuromodulation, Valencia, CA, USA
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Zhou X, Li X, Chen N, Chen Z, Yu H, Liang J, Fan Q, Zhu X, Zhang T, Zhou X, Du Q. Efficacy of sensorimotor training combined with core strength training for low back pain in adult idiopathic scoliosis: a study protocol for a randomized controlled trial. BMJ Open 2025; 15:e091476. [PMID: 40409968 DOI: 10.1136/bmjopen-2024-091476] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/25/2025] Open
Abstract
INTRODUCTION Sensorimotor training (SoMT) is a gradual balance training technique employed to treat various chronic musculoskeletal pain. Core strength training (CST) is one of the most commonly used interventions for managing low back pain (LBP). This randomied controlled trial protocol aims to determine whether the combination of SoMT and CST can significantly reduce LBP, and improve scoliosis-related outcomes and overall functional status in adult idiopathic scoliosis (AdIS) patients. METHODS AND ANALYSIS A total of 300 AdIS patients will be recruited from the outpatient clinic and randomly assigned to one of three groups: CST group, SoMT group or the combined therapy group, using stratified block randomization based on the severity of scoliosis curve. All groups will receive the intervention three times a week for 12 weeks. Sessions will be conducted in the hospital, and no home programme will be provided. Adherence and attendance will be monitored and recorded. The CST group will receive CST therapy, while the SoMT group will receive SoMT therapy, which consists of three progressive phases: static, dynamic and functional. Participants will progress to the next phase on achieving pelvic stability in the current phase. The combined therapy group will receive both CST and SoMT. Assessors and statisticians will remain blinded to participant allocation throughout the study. Assessments will be performed at baseline and at the endpoint, 12 weeks after the initiation of the intervention. The primary outcome will be the self-reported pain level, measured using the visual analogue scale. Secondary outcomes will include pain-related disability (by the Oswestry Disability Index and the Roland-Morris Disability Questionnaire), spinal morphology indicators (including Cobb angle, the angle of trunk rotation and the Sagittal Index), postural control ability (by the Tetrax IBSTM), proprioceptive sensitivity (by the repositioning error test) and health-related quality of life (by the 36-Item Short Form Health Survey). Statistical analysis will adhere to the intention-to-treat principle and will be complemented by per-protocol analysis. To compare the effects of SoMT versus CST and combined therapy versus SoMT on both primary and secondary outcomes, a linear mixed-effects model or generalised linear mixed model will be applied. ETHICS AND DISSEMINATION The current study received ethical approval from the Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2024-080-3). Written informed consent will be obtained from all participants. Any interim analysis and full results will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2400085370).
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Affiliation(s)
- Xiangyue Zhou
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Xin Li
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Shanghai University of Sport School of Exercise and Health, Shanghai, China
| | - Nan Chen
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Zhengquan Chen
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Hong Yu
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Juping Liang
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Qimeng Fan
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Xiaoqing Zhu
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Tongtong Zhang
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Xuan Zhou
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Qing Du
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
- Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China
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Licciardone JC, Lewis H, Dahl K, Adams B, Aryal S. Chronic pain outcomes among patients treated by osteopathic vs. allopathic physicians: a 36-month follow-up study. J Osteopath Med 2025:jom-2025-0037. [PMID: 40418798 DOI: 10.1515/jom-2025-0037] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2025] [Accepted: 04/29/2025] [Indexed: 05/28/2025]
Abstract
CONTEXT Osteopathic physicians take a whole-person approach to medical care that may be seen in their relationships with patients and may involve utilizing osteopathic manipulative treatment (OMT) as an alternative to opioid therapy in patients with chronic pain. OBJECTIVES This study aimed to compare the outcomes of patients with chronic low back pain (CLBP) treated by osteopathic and allopathic physicians in the United States utilizing a pragmatic design reflecting medical care in real-world settings, including an assessment of potential mediators of osteopathic medical care. METHODS A retrospective cohort study was conducted utilizing patients with CLBP selected from the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) from September 2016 through September 2024. Patients were followed at quarterly encounters for up to 36 months after PRECISION enrollment to determine if they were receiving their CLBP medical care from either osteopathic or allopathic physicians. Outcomes pertaining to pain, function, pain impact, health-related quality of life (HRQOL), and the frequency of chronic widespread pain (CWP) and CLBP recovery were also measured at these encounters utilizing generalized estimating equations. Results were adjusted for sociodemographic and clinical characteristics in multivariable analyses. Regression-based analyses were utilized to determine if OMT, opioid prescribing, or physician empathy mediate the outcomes of osteopathic medical care. RESULTS There were 1,491 patients in the study, including 278 (18.6 %) and 1,213 (81.4 %) treated by osteopathic and allopathic physicians, respectively. A total of 8,854 encounters were completed over 36 months, including 2,107 (23.8 %) and 6,747 (76.2 %) in the osteopathic and allopathic medical care groups, respectively. The adjusted means (95 % confidence intervals [CIs]) for patients treated by osteopathic vs. allopathic physicians were 6.3 (6.0-6.6) vs. 6.5 (6.3-6.7) for low back pain intensity (p=0.05); 14.8 (13.8-15.8) vs. 15.6 (14.8-16.4) for back-related disability (p=0.008); 31.9 (30.6-33.2) vs. 32.7 (31.7-33.7) for pain impact (p=0.07); and 57.8 (56.7-58.8) vs. 58.4 (57.6-59.3) for HRQOL deficits (p=0.04). The frequency of CWP occurrence (risk ratio [RR], 1.00; 95 % CI, 0.87-1.15; p=0.98) and CLBP recovery (RR, 0.65; 95 % CI, 0.38-1.11; p=0.12) did not differ between the osteopathic and allopathic medical care groups after adjusting for potential confounders. The significant results pertaining to pain, function, and HRQOL were consistently and most strongly mediated by physician empathy and, to a lesser extent, by OMT. CONCLUSIONS This study found that patients with CLBP treated by osteopathic physicians reported better outcomes for pain, function, and HRQOL than patients treated by allopathic physicians over 36 months of follow-up. These effects of osteopathic medical care were most consistently and strongly mediated by physician empathy and, to a lesser extent, by OMT. Osteopathic medical care was not associated with decreased CWP occurrence or increased CLBP recovery.
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Affiliation(s)
- John C Licciardone
- The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth, TX, USA
| | | | - Kaylee Dahl
- The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth, TX, USA
| | - Branden Adams
- The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth, TX, USA
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Barbier G, Descarreaux M, Cottin F, Lardon A. Prognostic factors associated with improvement in patients with an episode of non-specific low back pain without radicular syndrome: a prospective observational exploratory study. Chiropr Man Therap 2025; 33:21. [PMID: 40399987 PMCID: PMC12096604 DOI: 10.1186/s12998-025-00580-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2024] [Accepted: 03/25/2025] [Indexed: 05/23/2025] Open
Abstract
BACKGROUND Low back pain is a leading cause of disability worldwide, with most cases classified as non-specific(NSLBP). While manual therapy appears effective for treating NSLBP, further research is needed to identify candidate baseline factors associated with improvement to help tailor personalized treatment strategies. This prospective observational exploratory study, therefore, aims to identify candidate prognostic factors collected at baseline that are associated with short-term improvement in people with NSLBP. METHODS This study was conducted in chiropractic clinics across France between March 1, 2022, and February 28, 2023. Adults with a new episode of NSLBP were included. Baseline data, including individual, clinical, and therapist-related candidate factors, were collected before and during the initial consultation. Participants were considered improved if they: (i) reported "all better" or "better" on perceived global change, (ii) achieved a 20-point improvement on both Visual Analog Scales (VAS for intensity and unpleasantness) or scored 0 on reassessment, and (iii) showed a 30% improvement on the Oswestry Disability Index (ODI) at 7 days and 4 weeks post-consultation. Missing data were handled using multiple imputation with chained equations (MICE). Logistic regression analyses (univariate and multivariable with spline terms when superior fit was demonstrated) identified candidate prognostic factors associated with clinical improvement. RESULTS Out of 1,394 patients contacted, 241 met the inclusion criteria, and 207 completed at least one follow-up assessment. After imputation and multivariable analysis, duration of episode (spline 1: 0.94[0.89-1.00]), Number of painful sites (0.75[0.62-0.92]), negative treatment expectations (0.48 [0.25-0.94]), disability score (spline 1: 0.94[0.89-1.00], spline 2: 0.77[0.62-0.96]), and pain intensity (1.05 [1.02-1.07]) were associated with improvement at 7 days. At 4 weeks, disability score (spline 1: 1.24[1.07-1.45], spline 2: 0.77[0.63-0.95]), pain intensity (1.02 [1.00-1.04]), episode duration (spline 1: 0.95[0.91-1.00]), new patient (0.50 [0.28-0.91]), and clinican's prognosis (3.89 [1.49-10.10]) were associated with improvement. CONCLUSION Less-studied factors, such as negative treatment expectations, clinician's prognosis, number of therapists, and perceived stiffness, highlighted significant associations with improvement in this exploratory phase. These findings suggest that incorporating these factors may be used when updating existing models.
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Affiliation(s)
- Gaetan Barbier
- CIAMS, Université Paris-Saclay, Orsay Cedex, 91405, France.
- CIAMS, Université d'Orléans, Orléans, 45067, France.
- Institut Franco-Européen de Chiropraxie, Ivry-sur-Seine, 94200, France.
| | - Martin Descarreaux
- Institut Franco-Européen de Chiropraxie, Ivry-sur-Seine, 94200, France
- Department of Human Kinetics, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, Canada
| | - François Cottin
- Université Paris-Saclay, Inria, CIAMS, Gif-sur-Yvette, 91190, France
| | - Arnaud Lardon
- CIAMS, Université Paris-Saclay, Orsay Cedex, 91405, France
- CIAMS, Université d'Orléans, Orléans, 45067, France
- Institut Franco-Européen de Chiropraxie, Ivry-sur-Seine, 94200, France
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Nauer S, Porchet F, Kleinstueck FS, Haschtmann D, Burgstaller JM, Fekete TF, Loibl M, Mannion AF. How reliable are the Core Outcome Measures Index and Global Treatment Outcome as measures of treatment success after surgery for central lumbar spinal canal stenosis? EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2025:10.1007/s00586-025-08894-x. [PMID: 40381017 DOI: 10.1007/s00586-025-08894-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/17/2024] [Revised: 03/26/2025] [Accepted: 04/25/2025] [Indexed: 05/19/2025]
Abstract
INTRODUCTION The reliability of patient-reported outcome measures is typically evaluated in patients with chronic or stable symptoms, pre-treatment. After treatment, symptoms may be less extreme and less variable within a group, which may influence indices of reliability. Further, few studies have examined the reliability of retrospective, single item global assessment scores after treatment, despite the latter often being used as the external criterion when determining an instrument's minimal clinically important change (MCIC) score. This study examined the stability of Core Outcome Measures Index (COMI) and Global Treatment Outcome (GTO) scores after spine surgery. METHODS Data were extracted for patients with lumbar spinal stenosis who had completed the COMI and GTO twice at follow-up, for both an in-house outcomes database (ROUTINE) and as part of a separate prospective study (LSOS). To be included, the questionnaires had to have been completed within 3 months of each other for 1-year follow-up (FU), within 4 months for 2-year FU and within 5 months for 5-year FU. Repeated measures ANOVA, intraclass correlation coefficients (ICC; 2-way mixed, absolute agreement), and weighted Kappa values were calculated. RESULTS 64 patients (72.9 ± 6.9 y; 48% female) had a COMI and GTO available from both ROUTINE and LSOS, completed on average 9.8 ± 6.2 weeks apart. There were no significant differences between test and retest scores for any of the COMI domains or for the COMI summary score (all p > 0.05), and ICCs/weighted Kappas were moderate to good (0.73-0.87). In the ROUTINE and LSOS datasets, 83% and 81% patients, respectively, reported a "good global outcome" on the GTO (i.e. treatment helped/helped a lot); the corresponding Kappa for agreement between the ratings on an individual basis was 0.74 ("good agreement"). CONCLUSION Despite the more stringent nature of the evaluation given by this "real-life" analysis of the stability of outcome scores, the FU COMI scores showed moderate to good reliability comparable to that reported in previous studies with reliability assessed 1-2 weeks apart. The GTO was also confirmed as a reliable variable yielding stable values at mid to longer term follow-up.
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Affiliation(s)
- Selina Nauer
- Department of Teaching, Research and Development, Schulthess Klinik, Zurich, Switzerland
| | - François Porchet
- Department of Spine Surgery and Neurosurgery, Schulthess Klinik, Zurich, Switzerland
| | - Frank S Kleinstueck
- Department of Spine Surgery and Neurosurgery, Schulthess Klinik, Zurich, Switzerland
| | - Daniel Haschtmann
- Department of Spine Surgery and Neurosurgery, Schulthess Klinik, Zurich, Switzerland
| | - Jakob M Burgstaller
- Institute of Primary Care, University Hospital and University of Zurich, Zurich, Switzerland
| | - Tamas F Fekete
- Department of Spine Surgery and Neurosurgery, Schulthess Klinik, Zurich, Switzerland
| | - Markus Loibl
- Department of Spine Surgery and Neurosurgery, Schulthess Klinik, Zurich, Switzerland
| | - Anne F Mannion
- Department of Teaching, Research and Development, Schulthess Klinik, Zurich, Switzerland.
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Leem I, Lee GB, Wang JW, Pyun SW, Kum CJ, Lee JH, Kim HD. Impact of Hip Exercises on Postural Stability and Function in Patients with Chronic Lower Back Pain. Diagnostics (Basel) 2025; 15:1229. [PMID: 40428222 PMCID: PMC12110692 DOI: 10.3390/diagnostics15101229] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2025] [Revised: 05/10/2025] [Accepted: 05/11/2025] [Indexed: 05/29/2025] Open
Abstract
Background and Objective: This study aimed to compare functional and clinical outcomes between patients with chronic non-specific lower back pain (NSLBP) with restricted hip extension mobility who performed spinal stabilization exercises with hip mobilization either with or without additional hip exercises. Methods: A total of 42 patients with chronic NSLBP with restricted hip extension mobility were enrolled (21 with and 21 without additional hip exercises). Functional and clinical outcomes were assessed based on hip joint mobility, back extensor endurance, postural stability, and patient-reported outcomes, including visual analog scale (VAS) and Oswestry disability index (ODI) scores. Results: A significant group-time interaction was identified for postural stability (Rt: p < 0.001, Lt: p = 0.002) and the ODI (p = 0.004). After the intervention, the group with additional hip exercises demonstrated significantly greater improvements in postural stability (Rt: p < 0.001; Lt: p = 0.01) and ODI scores (p < 0.001) compared with the group without additional hip exercises. However, no significant main group effect or group-time interaction was observed for the hip joint mobility, back extensor endurance, or VAS scores (all p > 0.05). Furthermore, the ODI score (r2 = 0.123, p = 0.023) was an independent predictor of hip joint mobility but not the VAS score (p > 0.05). Conclusions: Hip exercises may improve postural stability and function in patients with chronic NSLBP with restricted hip extension mobility. Notably, clinicians and therapists must recognize the importance of hip exercises during rehabilitation of patients with chronic NSLBP with restricted hip extension mobility.
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Affiliation(s)
- Inhwan Leem
- Department of Physical Therapy, School of Health and Environmental Science, College of Health Science, Korea University, Seoul 02841, Republic of Korea;
- 365 Maeil Korean Medicine Hospital, Seoul 02582, Republic of Korea;
| | - Gyu Bin Lee
- Department of Sports Medical Center, Anam Hospital, College of Medicine, Korea University, Seoul 02841, Republic of Korea; (G.B.L.); (J.W.W.); (S.W.P.)
| | - Ji Won Wang
- Department of Sports Medical Center, Anam Hospital, College of Medicine, Korea University, Seoul 02841, Republic of Korea; (G.B.L.); (J.W.W.); (S.W.P.)
| | - Sang Woo Pyun
- Department of Sports Medical Center, Anam Hospital, College of Medicine, Korea University, Seoul 02841, Republic of Korea; (G.B.L.); (J.W.W.); (S.W.P.)
| | - Chang-Jun Kum
- 365 Maeil Korean Medicine Hospital, Seoul 02582, Republic of Korea;
| | - Jin Hyuck Lee
- Department of Sports Medical Center, Anam Hospital, College of Medicine, Korea University, Seoul 02841, Republic of Korea; (G.B.L.); (J.W.W.); (S.W.P.)
| | - Hyeong-Dong Kim
- Department of Physical Therapy, School of Health and Environmental Science, College of Health Science, Korea University, Seoul 02841, Republic of Korea;
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Mayer TA, Koska D, Harsch AK, Maiwald C. Effectiveness of Self-Training With a Web-Based Digital Health Application Versus Physiotherapy in the Treatment of Disorders of the Patella: Randomized Controlled Trial. J Med Internet Res 2025; 27:e66463. [PMID: 40323642 PMCID: PMC12089869 DOI: 10.2196/66463] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2024] [Revised: 02/14/2025] [Accepted: 04/03/2025] [Indexed: 05/07/2025] Open
Abstract
BACKGROUND Disorders of the patella are among the most prevalent knee injuries. While exercise therapy is widely accepted as an effective treatment strategy, the positive effects of conventional exercise therapy under the guidance of a physiotherapist may be offset by inherent limitations, such as difficulties in scheduling appointments or statutory policies restricting the number of training sessions. Home-based exercise interventions using digital health applications (DHAs) may help address some of these limitations. OBJECTIVE This study aimed to assess the efficacy of a 12-week exercise intervention using a web-based DHA for improving knee function and reducing pain in patients with disorders of the patella (International Classification of Diseases code M22). METHODS The outcomes of the DHA intervention group (IG) were compared to a control group (CG) that received conventional physiotherapy covered by statutory health insurance in Germany (SHI-PT). A total of 259 patients with diagnosed disorders of the patella were included in the trial and randomly allocated to IG DHA (n=136, 52.5%) and CG SHI-PT (n=123, 47.5%). Two primary end points were examined: "knee function" (Knee Injury and Osteoarthritis Outcome Score-Activities of Daily Living [KOOSADL] subscale, range 0-100 points) and "knee pain" (visual analog scale [VAS], range 0-100 points). Participants were asked to complete 2 surveys: one before the first therapy session (PRE) and one after completing the treatment period of 12 weeks (POST). RESULTS Training with the DHA resulted in a 4.5-fold greater improvement in "knee function" (PRE-POST differences in KOOSADL score; IG DHA: 15.7 points, 95% CI 13.7-17.6 vs CG SHI-PT: 3.5 points, 95% CI 1.5-5.5) and a 3.5-fold greater reduction in "knee pain" (PRE-POST differences in VAS pain score; IG DHA: -22.5 points, 95% CI -25.2 to -19.9 vs CG SHI-PT: -6.5 points, 95% CI -8.7 to -4.4) compared to SHI-PT. The improvements in IG DHA exceeded the limits of clinical relevance. The differences between the treatment groups (KOOSADL score -10.1 points, 95% CI -infinity to -8.0; VAS pain score 14.3 points 95% CI 11.7-infinity) were statistically significant (P<.001) for both end points in favor of IG DHA. No effect was found for age or sex. The reported use of pain medication decreased substantially in IG DHA, and showed almost no change in CG SHI-PT. CONCLUSIONS Our findings indicated that the investigated DHA is superior to SHI-PT for treating disorders of the patella. Therefore, DHA has been approved by the German Federal Institute for Drugs and Medical Devices for treating disorders of the patella in persons of all sexes aged ≥12 years. TRIAL REGISTRATION German Clinical Trials Register (DRKS) DRKS00023454; https://drks.de/search/en/trial/DRKS00023454.
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Affiliation(s)
- Tobias A Mayer
- Department of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany
| | - Daniel Koska
- Department of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany
| | - Ann-Kathrin Harsch
- Department of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany
| | - Christian Maiwald
- Department of Research Methodology and Data Analysis in Biomechanics, Institute of Human Movement Science and Health, Chemnitz University of Technology, Chemnitz, Germany
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10
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Beall DP, Davis TT, Amirdelfan K, Naidu RK, DePalma MJ, Costandi S, Yoon ES, Fleming JW, Block JE, Mekhail N. Supplemental nucleus pulposus allograft in patients with lumbar discogenic pain: results of a prospective feasibility study. BMC Musculoskelet Disord 2025; 26:437. [PMID: 40312677 PMCID: PMC12044970 DOI: 10.1186/s12891-025-08701-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/27/2024] [Accepted: 04/24/2025] [Indexed: 05/03/2025] Open
Abstract
BACKGROUND Degeneration of the intervertebral disc is a significant source of chronic axial low back pain. Direct supplementation of degenerated nucleus pulposis (NP) tissue with intradiscally delivered allogeneic NP represents an opportunity to bridge the treatment gap between failed conservative care and spine surgery for patients with lumbar discogenic pain. METHODS Prospective, single-arm clinical study conducted at 6 sites in the US. The primary objective was to determine the magnitude of improvement in back pain severity and back function in patients with chronic lumbar discogenic pain at 12 months after a single intradiscal supplementation procedure using a commercially available NP allograft at up to two vertebral levels identified on magnetic resonance imaging. Back pain severity was evaluated using an 11-point numeric rating scale (NRS) and back function using the Oswestry Disability Index (ODI). Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) were set at ≥ 30% and ≥ 50% over baseline, respectively. The patient acceptable symptom state (PASS) threshold for pain severity was ≤ 3. RESULTS Twenty-eight participants with a mean age of 44 ± 13 yrs. were enrolled and 22 provided 12-month outcomes. The average overall improvement in back pain severity was 43% through 12 months (p < 0.001). Approximately 64% (14 of 22) achieved the MCID in back pain at 12 months, with 55% (12 of 22) realizing SCB. Almost 60% (13 of 22) reported a 12-month back pain severity score of ≤ 3. The corresponding average decrease in ODI values was 50% (p < 0.001) with approximately 59% (13 of 22) of study participants achieving the MCID. At baseline approximately 82% (23 of 28) of participants reported severe or crippled back impairment compared to 18% (4 of 22) at 12 months (p < 0.001). CONCLUSION The results of this study provide additional evidence that supplementation of the degenerated intervertebral disc with intradiscally delivered allogeneic NP is associated with clinically significant pain palliation and functional improvement. TRIAL REGISTRATION This trial was prospectively registered at ClinicalTrials.gov on December 30, 2021 (NCT05201287).
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Affiliation(s)
- Douglas P Beall
- Comprehensive Specialty Care, 1023 Waterwood Pkwy, Edmond, OK, 73034, USA
| | - Timothy T Davis
- Source Healthcare, 2801 Wilshire Blvd, Ste. A, Santa Monica, CA, 90403, USA
| | - Kasra Amirdelfan
- Boomerang Healthcare, Inc, 450 N. Wiget Lane, Walnut Creek, CA, 94598, USA
| | - Ramana K Naidu
- MarinHealth Spine Institute, 2 Bon Air Road, Ste. 120, Larkspur, CA, 94939, USA
| | - Michael J DePalma
- Virginia iSpine Physicians, 12874 Patterson Avenue, Ste. A, Richmond, VA, 23238, USA
| | - Shrif Costandi
- Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA
| | - Edward S Yoon
- Hospital for Special Surgery, 535 East 70 Street, New York, NY, 10021, USA
| | | | - Jon E Block
- , 2210 Jackson Street, Ste. 401, San Francisco, CA, 94115, USA.
| | - Nagy Mekhail
- Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA
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11
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Gjefsen E, Bråten LC, Ponzi E, Dagestad MH, Marchand GH, Kadar T, Bakland G, Haugen AJ, Granviken F, Flørenes TW, Vetti N, Grøvle L, Nilsen AT, Lunestad A, Holmgard TE, Valberg M, Bolstad N, Espeland A, Brox JI, Goll GL, Storheim K, Zwart J. Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial. Arthritis Rheumatol 2025; 77:615-623. [PMID: 39624017 PMCID: PMC12039465 DOI: 10.1002/art.43073] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2024] [Revised: 09/27/2024] [Accepted: 11/18/2024] [Indexed: 01/18/2025]
Abstract
OBJECTIVE The efficacy of tumor necrosis factor inhibitors for treating chronic low-back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic type 1 changes. METHODS In this multicenter, randomized, triple-blind, placebo-controlled trial, patients aged 18 to 65 years with moderate to severe chronic low-back pain and Modic type 1 changes were enrolled from five Norwegian public hospitals between January 2019 and October 2022. Participants were randomly assigned to four intravenous infusions of 5 mg/kg infliximab or placebo. The primary outcome was difference in change in the Oswestry Disability Index (ODI) score from baseline to five months. Secondary outcomes included changes in low-back pain intensity, disability, and health-related quality of life. A linear mixed model was used for efficacy analyses. RESULTS A total of 128 patients (mean age 43 years, 65.6% women) participated (64 in each group). All patients who received at least one dose of the allocated infusion were included in the primary analyses. The average ODI score (±SD) change was -7.0 (±9.7) in the group who received infliximab and -6.4 (±10.4) in the group who received placebo. The difference in the ODI score change between the two groups was 1.3 ODI points (95% confidence interval -2.1 to 4.6, P = 0.45). Analyses showed no effect of infliximab compared to placebo on secondary outcomes. Adverse event rates were similar between groups. CONCLUSION Infliximab did not demonstrate superiority over placebo in reducing pain-related disability in patients with moderate to severe chronic low-back pain with Modic type 1 changes at five months.
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Affiliation(s)
| | | | | | | | - Gunn H. Marchand
- St Olav's Hospital, Trondheim University HospitalTrondheimNorway
| | | | | | | | - Fredrik Granviken
- St Olav's Hospital, Trondheim University Hospital and Norwegian University of Science and TechnologyTrondheimNorway
| | | | - Nils Vetti
- Haukeland University Hospital and University of BergenBergenNorway
| | | | | | - Astrid Lunestad
- Norwegian Association for Female Pelvic Joint Health, GrønlandOsloNorway
| | | | - Morten Valberg
- Oslo University Hospital and University of OsloOsloNorway
| | | | - Ansgar Espeland
- Haukeland University Hospital and University of BergenBergenNorway
| | - Jens I. Brox
- Oslo University Hospital and University of OsloOsloNorway
| | - Guro L. Goll
- Diakonhjemmet Hospital and University of OsloOsloNorway
| | - Kjersti Storheim
- Oslo University Hospital and Oslo Metropolitan UniversityOsloNorway
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Granviken F, Meisingset I, Bach K, Bones AF, Simpson MR, Hill JC, van der Windt DA, Vasseljen O. Personalised decision support in the management of patients with musculoskeletal pain in primary physiotherapy care: a cluster randomised controlled trial (the SupportPrim project). Pain 2025; 166:1167-1178. [PMID: 39432806 PMCID: PMC12004987 DOI: 10.1097/j.pain.0000000000003456] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2024] [Revised: 09/11/2024] [Accepted: 09/12/2024] [Indexed: 10/23/2024]
Abstract
ABSTRACT We developed the SupportPrim PT clinical decision support system (CDSS) using the artificial intelligence method case-based reasoning to support personalised musculoskeletal pain management. The aim of this study was to evaluate the effectiveness of the CDSS for patients in physiotherapy practice. A cluster randomised controlled trial was conducted in primary care in Norway. We randomised 44 physiotherapists to (1) use the CDSS alongside usual care or (2) usual care alone. The CDSS provided personalised treatment recommendations based on a case base of 105 patients with positive outcomes. During the trial, the case-based reasoning system did not have an active learning capability; therefore, the case base size remained the same throughout the study. We included 724 patients presenting with neck, shoulder, back, hip, knee, or complex pain (CDSS; n = 358, usual care; n = 366). Primary outcomes were assessed with multilevel logistic regression using self-reported Global Perceived Effect (GPE) and Patient-Specific Functional Scale (PSFS). At 12 weeks, 165/298 (55.4%) patients in the intervention group and 176/321 (54.8%) in the control group reported improvement in GPE (odds ratio, 1.18; confidence interval, 0.50-2.78). For PSFS, 173/290 (59.7%) patients in the intervention group and 218/310 (70.3%) in the control group reported clinically important improvement in function (odds ratio, 0.41; confidence interval, 0.20-0.85). No significant between-group differences were found for GPE. For PSFS, there was a significant difference favouring the control group, but this was less than the prespecified difference of 15%. We identified several study limitations and recommend further investigation into artificial intelligence applications for managing musculoskeletal pain.
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Affiliation(s)
- Fredrik Granviken
- Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway
- Clinic of Rehabilitation, St Olav's Hospital, Trondheim University Hospital, Trondheim, Norway
| | - Ingebrigt Meisingset
- Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway
- Unit for Physiotherapy Services, Trondheim Municipality, Trondheim, Norway
| | - Kerstin Bach
- Department of Computer Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway
| | - Anita Formo Bones
- Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway
| | - Melanie Rae Simpson
- Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway
| | - Jonathan C. Hill
- School of Medicine, Primary Care Centre Versus Arthritis, Keele University, Keele, United Kingdom
| | | | - Ottar Vasseljen
- Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway
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13
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Lara-Palomo IC, Capel-Alcaraz AM, García-López H, Castro-Sánchez AM, Querol-Zaldívar MDLÁ, Fernández-Sánchez M. Effectiveness of monopolar diathermy by radiofrequency combined with exercise in patients with chronic low back pain: A randomized clinical trial. J Back Musculoskelet Rehabil 2025; 38:420-433. [PMID: 39392597 DOI: 10.3233/bmr-240118] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/12/2024]
Abstract
BackgroundChronic low back pain can severely affect quality of life. While several treatments are available, the combination of therapies often results in better outcomes.ObjectiveThis study delves into the comparative effectiveness of combining monopolar dielectric diathermy radiofrequency (MDR) with supervised therapeutic exercise against the latter treatment alone.MethodsA randomized single-blind controlled trial was conducted. The intervention group (( n = 30 ) 30) received MDR with supervised therapeutic exercises for eight weekly sessions for four weeks. The control group (n = 30) received only the same exercise protocol. The following self-report measures were assessed before the first treatment session, at four, and 12 weeks: disability, pain, kinesiophobia, quality of life, sleep quality, emotional distress, isometric trunk strength, and trunk flexion range.ResultsRepeated ANOVA measures revealed significant time*group interactions for the McQuade test (p = 0.003), the physical role (p = 0.011), vitality (p = 0.023), social function (p = 0.006), and mental health subscales (p = 0.042). Between-group analyses showed significant differences for all outcomes at each follow-up: RMDQ (post-treatment, p = 0.040), ODI (post-treatment and 12-week, p = 0.040), VAS (p < 0.001), TSK (p < 0.001), and McQuade Test (p < 0.020).ConclusionThe combination of diathermy radiofrequency with supervised therapeutic exercise significantly surpasses the efficacy of supervised therapeutic exercise alone, showcasing improvements in pain, disability, kinesiophobia, lumbar mobility in flexion, and overal quality of life in patients with chronic low back pain.
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Affiliation(s)
- Inmaculada Carmen Lara-Palomo
- Department of Nursing, Physical Therapy and Medicine, University of Almeria, La Cañada de San Urbano, Almería, Spain
| | - Ana María Capel-Alcaraz
- Department of Nursing, Physical Therapy and Medicine, University of Almeria, La Cañada de San Urbano, Almería, Spain
| | - Héctor García-López
- Department of Nursing, Physical Therapy and Medicine, University of Almeria, La Cañada de San Urbano, Almería, Spain
| | - Adelaida María Castro-Sánchez
- Department of Nursing, Physical Therapy and Medicine, University of Almeria, La Cañada de San Urbano, Almería, Spain
| | | | - Manuel Fernández-Sánchez
- Department of Nursing, Physical Therapy and Medicine, University of Almeria, La Cañada de San Urbano, Almería, Spain
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John B, Røe C, Brox JI, Sveinall H, Ignatius J, Wilhelmsen M, Skatteboe S. Responsiveness and minimal important change of neck disability index and numeric pain rating scale for neck patients in the Norwegian neck and back register. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2025:10.1007/s00586-025-08836-7. [PMID: 40272496 DOI: 10.1007/s00586-025-08836-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Revised: 03/18/2025] [Accepted: 03/29/2025] [Indexed: 04/25/2025]
Abstract
PURPOSE To evaluate the responsiveness and the minimal important change (MIC) of Neck Disability Index (NDI) and pain during activity by the numeric rating scale (NRSa) in the Norwegian neck and back registry (NNRR). MATERIALS AND METHODS Participants with neck pain responding to baseline, 6 and 12-months follow-up in the NNRR were included. Responsiveness was calculated using the area under the receiver operating characteristic (ROC). The minimal important change (MIC) was calculated with an anchor-based method and distribution-based methods. For the anchor-based method we used the Patient Global Impression of Change (PGIC) as the anchor. The PGIC was on a 7-point Likert scale, and trichotomized into three ordinal categories. RESULTS A total of 551 patients with neck pain were included. Among these patients, 60% were women with an average age of 48, and 63% had experienced neck pain for more than one year. For improved patients NDI and NRSa had adequate responsiveness at both follow-ups. MIC calculations using an anchor-based method were more accurate than those using a distribution-based method, which fell below the measurement error for the instruments. Using anchor-based calculation of MIC, the MIC for NDI was 17 at the 6-months follow-up and 9 at 12-months follow-up. Correspondingly, NRSa had a MIC of 2.5 at both follow-ups. CONCLUSION NDI and NRSa were responsive at both 6-months and 12-months follow-up and can be used in registries following patients with neck pain over time.
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Affiliation(s)
| | - Cecilie Røe
- Oslo University Hospital, Oslo, Norway
- University of Oslo, Oslo, Norway
| | - Jens Ivar Brox
- Oslo University Hospital, Oslo, Norway
- University of Oslo, Oslo, Norway
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15
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Mokhtarinia HR, Cuesta-Vargas A, Dibai-Filho AV, Melloh M, Bejer A. A shortened 10-item Spine Functional Index: clinimetric properties indicate a reliable, responsive and practical measure. BMC Musculoskelet Disord 2025; 26:370. [PMID: 40241107 PMCID: PMC12001575 DOI: 10.1186/s12891-025-08604-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/03/2025] [Accepted: 03/31/2025] [Indexed: 04/18/2025] Open
Abstract
BACKGROUND To assess the 10-item Spine Functional Index (SFI-10) clinimetric properties in a general musculoskeletal disorder (MSD) spine population. Ascertain the psychometric characteristics' consistency with the developmental study findings for structural and criterion validity, internal consistency, and floor/ceiling effect; establish the longitudinal characteristics for test-retest reliability, responsiveness, construct validity, and error scores; and clarify practical characteristics of readability, missing responses, and time/errors for completion/scoring related to administrative burden. METHODS A longitudinal study of deidentified spine MSD patients (n = 1317, 53.4% female, age = 18-91yrs, av = 49.5 ± 16.4yrs; neck = 36.5%, mid-back = 8.4%, low back = 56.0%, multi-site = 0.3%) who completed the SFI-10, the Patient Specific Functional Scale (PSFS), and Numerical Rating Scales for Global-function (G-NRS) and Pain (P-NRS). Structural validity used factor analysis, exploratory (EFA) and confirmatory (CFA), plus Rasch analysis. Criterion validity used Spearman's correlation coefficient (r) between the SFI-10 and criteria (PSFS, G-NRS and P-PRS) scores, and construct validity (n = 91, known-groups independent t-test). Internal consistency used Cronbach's alpha (α) and floor/ceiling effects were determined. Subgroups determined reliability (n = 104, intraclass correlation coefficient, ICC2.1); error (n = 171) through the standard error of measurement (SEM) and minimum detectable change (MDC90). Responsiveness (n = 171) was calculated using effect-size (ES), standard response mean (SRM), and area under the curve (AUC); and interpretability through the minimal clinically important difference (MCID). Practicality (n = 16) clarified missing responses, readability, and time/errors for completion/scoring. RESULTS The SFI-10's structural validity was unequivocally one-dimensional from EFA and verified by CFA with acceptable fit-indices (chi-square/df = 2.88, CFI = 0.981, TLI = 0.975, RMSEA = 0.061), and supported by Rasch analysis (PSR = 0.79, Infit = 0.678-1.216, Outfit = 0.604-1.279, Item-difficulties = -1,215-2.488). Criterion validity varied from high (G-NRS, r = 0.60) and moderate (PSFS, r = 0.43) to low-inverse (P-NRS, r = -0.24). Internal consistency was strong (α = 0.84) and no floor/ceiling effects were present. Reliability was excellent (ICC2.1 = 0.97), responsiveness substantial (ES = 1.54; SRM = 1.64; AUC = 0.89), and measurement error robust (SEM = 3.84; MDC90 = 8.98%, MDIC = 10.4%), with construct validity confirmed (p < 0.001). Practicality showed no missing responses, completion/scoring errors < 1%, excellent readability (Grade = 5.1, Ease = 74.1%), short completion (39.2 ± 10.3 s) and scoring times (8.5 ± 1.8 s). CONCLUSIONS The SFI-10 demonstrates sound measurement properties in a general physiotherapy outpatient MSD spine population for both psychometric and practical characteristics. Further investigation in culturally diverse settings that include both inpatients and community settings with whole-spine and regional-spine criteria is required.
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Affiliation(s)
- Hamid Reza Mokhtarinia
- Department of Ergonomics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
- Neuromusculoskeletal Rehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
| | - Antonio Cuesta-Vargas
- Department of Physiotherapy, Faculty of Health Science at the University of Malaga, IBIMA, Málaga, Spain
| | - Almir Vieira Dibai-Filho
- Postgraduate Program in Physical Education, Federal University of Maranhao, Sao Luis, Maranhao, Brazil
| | - Markus Melloh
- School of Health Sciences, Zurich University of Applied Sciences, Winterthur, Switzerland
| | - Agnieszka Bejer
- Faculty of Health Sciences and Psychology, Collegium Medicum, University of Rzeszów, Rzeszów, Poland
- The Holy Family Specialist Hospital, Rudna Mała 600, Głogów, Głogów Małopolski, 36 - 060, Poland
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Sabina S, Monteleone D, Mincarone P, Maiorano P, Guarino R, Tumolo MR, Leo CG, Giordano A, Zisi M. A Quasi-Experimental Controlled Study to Evaluate the Effects of a Kinesiologic Approach-The Canali Postural Method-To Posture Reprogramming for Non-Specific Low Back Pain. Healthcare (Basel) 2025; 13:869. [PMID: 40281817 PMCID: PMC12026616 DOI: 10.3390/healthcare13080869] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2025] [Revised: 04/03/2025] [Accepted: 04/04/2025] [Indexed: 04/29/2025] Open
Abstract
BACKGROUND/OBJECTIVES Low back pain (LBP) is the leading cause of disability worldwide, with most cases classified as non-specific low back pain (NSLBP). Various treatments exist, among which are physical exercises that promote flexibility, mobility and core stabilization, improving muscle function and body posture. The Canali Postural Method (CPM) is a kinesiological method that offers a personalized approach to postural reprogramming. This study compares the effects of the CPM and generic exercises in individuals with NSLBP. METHODS Subjects with NSLBP were engaged in a four-week intervention either based on a CPM reprogramming phase (CPM group) or generic exercises for the control group (CG). The CPM group underwent an assessment phase to identify the possible musculoskeletal causes of compensatory postural arrangements. The functional disability and pain level were assessed before, immediately after and 3 months post-intervention in both groups. Data were analyzed using repeated measures ANOVA. RESULTS Thirty-five subjects per group participated, with the CPM group averaging 38.6 ± 10.1 years and the CG 40.2 ± 12.1 years. The CPM group experienced significantly greater pain relief both immediately post-intervention and at the 3-month follow-up (p < 0.001). While the disability perception decreased in both groups, the CPM group showed superior improvement at the 3-month follow-up (p < 0.001). CONCLUSIONS The CPM represents promise for enhancing motor control and quality of life, suggesting potential benefits for other musculoskeletal issues. Future research should explore its broader applications and underlying physiological mechanisms.
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Affiliation(s)
- Saverio Sabina
- Institute of Clinical Physiology, National Research Council, Branch of Lecce, 73100 Lecce, Italy; (S.S.); (R.G.); (M.R.T.); (C.G.L.)
- MOVE-mentis S.R.L., 47522 Cesena, Italy
| | - Daria Monteleone
- Sbarro Health Research Organization Italia, 10060 Candiolo, TO, Italy; (D.M.); (P.M.)
- Health Posture Training Lab, 80128 Naples, Italy
| | - Pierpaolo Mincarone
- MOVE-mentis S.R.L., 47522 Cesena, Italy
- Institute for Research on Population and Social Policies, National Research Council, Research Unit of Brindisi, 72100 Brindisi, Italy
| | - Patrizia Maiorano
- Sbarro Health Research Organization Italia, 10060 Candiolo, TO, Italy; (D.M.); (P.M.)
| | - Roberto Guarino
- Institute of Clinical Physiology, National Research Council, Branch of Lecce, 73100 Lecce, Italy; (S.S.); (R.G.); (M.R.T.); (C.G.L.)
- MOVE-mentis S.R.L., 47522 Cesena, Italy
| | - Maria Rosaria Tumolo
- Institute of Clinical Physiology, National Research Council, Branch of Lecce, 73100 Lecce, Italy; (S.S.); (R.G.); (M.R.T.); (C.G.L.)
- Department of Biological & Environmental Sciences & Technology, University of Salento, 73100 Lecce, Italy
| | - Carlo Giacomo Leo
- Institute of Clinical Physiology, National Research Council, Branch of Lecce, 73100 Lecce, Italy; (S.S.); (R.G.); (M.R.T.); (C.G.L.)
- MOVE-mentis S.R.L., 47522 Cesena, Italy
| | - Antonio Giordano
- Sbarro Institute for Cancer Research and Molecular Medicine and Center for Biotechnology, College of Science and Technology, Temple University, Philadelphia, PA 19122, USA;
- Department of Medical Biotechnologies, University of Siena, 53100 Siena, Italy
| | - Mirko Zisi
- Habitus et Motus S.R.L., 40046 Alto Reno Terme, BO, Italy;
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Smet I, Billet B, Germonpré PJ, Peña I, de la Osa AM, Keiner D, Polati E, Lindblom P, Minne V, Chowdhury S, Banducci SE, Tamosauskas R, Park N, Lalkhen A, Vajramani G, Dhamne S. Pain, quality of life, and function in chronic intractable leg pain were substantially improved with 10kHz spinal cord stimulation in a multicentre European study. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2025:10.1007/s00586-025-08752-w. [PMID: 40192770 DOI: 10.1007/s00586-025-08752-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/30/2023] [Revised: 02/07/2025] [Accepted: 02/14/2025] [Indexed: 04/27/2025]
Abstract
PURPOSE This prospective, single-arm, multicentre study evaluated the effectiveness of 10 kHz spinal cord stimulation (SCS) in relieving pain and improving function and quality of life in patients with chronic intractable leg pain in routine clinical practice. METHODS Patients with leg pain refractory to conservative therapy and scoring ≥ 5 cm on a 10-cm visual analog scale (VAS) were enrolled at 12 centres. Those who achieved ≥ 50% leg pain relief during a temporary trial underwent permanent implantation and were followed for 12 months. Outcomes collected included the proportion of patients who achieved ≥ 50% reduction in leg pain VAS score, health-related quality-of-life (EQ-5D-5 L, functional disability [ODI]), opioid use, sleep quality (PSQ-3), global impression of change (GIC), and patient satisfaction. RESULTS Of 121 patients trialed, 118 completed the trial and 95 proceeded to implant. At 3 months, 61/95 (64.2%) of all implanted patients were responders to therapy (≥ 50% VAS reduction), which remained stable at 64.2% through 12 months. EQ-5D-5 L, ODI, and PSQ-3 showed clinically important and sustained improvement over 12 months (repeated measures ANOVA, p < 0.001). Patients also reduced opioid dosage on average (p = 0.022). The safety profile was consistent with previous reports using 10 kHz SCS. CONCLUSION This study supports 10 kHz SCS as an effective and safe therapeutic option to reduce pain and disability while improving health-related quality of life in patients with chronic intractable leg pain. 10 kHz SCS appears to be effective in significantly improving the severe disability and poor quality of life experienced by patients with chronic intractable leg pain. STUDY REGISTERED ISRCTN Registry - ISRCTN11180496.
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Affiliation(s)
| | | | | | - Isaac Peña
- Hospital Universitario Virgen Del Rocio, Seville, Spain
| | | | - Doerthe Keiner
- Universitätsklinikum des Saarlandes Klinik für Neurochirurgie, Homburg, Germany
| | - Enrico Polati
- Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy
| | | | | | | | | | | | | | | | - Girish Vajramani
- University Hospital Southampton NHS Foundation Trust, Southampton, UK.
| | - Sameer Dhamne
- University Hospital Southampton NHS Foundation Trust, Southampton, UK.
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Manca A, Cugusi L, van Tulder M, Furlan A, Solla F, Monticone M. Oral non-benzodiazepine muscle-relaxants for people with acute and chronic primary low back pain: a systematic review with meta-analysis. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2025:10.1007/s00586-025-08786-0. [PMID: 40186696 DOI: 10.1007/s00586-025-08786-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/05/2024] [Revised: 12/21/2024] [Accepted: 03/07/2025] [Indexed: 04/07/2025]
Abstract
PURPOSE To determine benefits and adverse effects (AE) of oral muscle-relaxants (MR) (non-benzodiazepines) for acute (< 6 weeks) and chronic (> 12 weeks) primary LBP, administered alone or combined with analgesics/NSAIDs. METHODS CENTRAL, MEDLINE, EMBASE, CINAHL were searched for pertinent randomized controlled trials. Primary outcomes comprised lack of pain relief, global efficacy and AE at 5-7 days follow-up assessed dichotomously (risk ratio, RR). RESULTS Fifty studies (7531 participants) were included, with data from 4775 pooled in meta-analyses. For acute LBP, non-benzodiazepine MR were associated with increased likelihood of pain relief (moderate certainty; RR: 0.53, p < 0.0001), global efficacy (RR: 0.49, p = 0.0001), muscle spasm (RR: 0.62, p < 0.00001), and physical outcomes (RR: 0.60, p < 0.00001) compared to placebo. AE were more frequent with non-benzodiazepine MR compared to placebo (low-to-moderate certainty; RR: 1.56; p = 0.003), and at central nervous system (CNS; RR: 2.40; p < 0.00001), but not at gastrointestinal (GI) level (RR: 0.77; p = 0.62). Combined non-benzodiazepines + analgesics/non-steroidal anti-inflammatory drugs (NSAIDs) provide a larger and clinically meaningful benefit compared to placebo + analgesics/NSAIDs for global efficacy at 5-7 days (low-certainty; RR: 0.62; p = 0.01). Combined therapy did not result in significant between-group differences for total AE (moderate-certainty; RR: 1.15; p = 0.50) and GI AE (RR: 0.63; p = 0.08), despite responsible for more CNS AE (low-certainty; RR: 1.91; p = 0.002). When comparing non-benzodiazepine MR versus placebo for chronic LBP, only data on total AE could be pooled, without between-group difference (RR: 0.93; p = 0.69). CONCLUSIONS Non-benzodiazepine MR for acute LBP were associated with increased likelihood of pain relief and global efficacy compared to placebo. Combined therapy with analgesics/NSAIDs proved superior for global efficacy. Studies are needed to evaluate if non-benzodiazepine MR are of larger benefit than analgesics/NSAIDs, and if stand-alone administration provides more benefit than combined treatment. The observed AE warrant caution.
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Affiliation(s)
- Andrea Manca
- Department of Biomedical Sciences, University of Sassari, Sassari, Italy.
| | - Lucia Cugusi
- Department of Biomedical Sciences, University of Sassari, Sassari, Italy
| | - Maurits van Tulder
- Department of Human Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit, Amsterdam, Netherlands
| | - Andrea Furlan
- Department of Medicine, University of Toronto, Toronto, ON, Canada
| | - Federico Solla
- Surgery Unit, Lenval University Childrens Hospital, Nice, France
| | - Marco Monticone
- Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
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Bogaert L, Thys T, Van Wambeke P, Janssens L, Swinnen TW, Moke L, Schelfaut S, Dejaegher J, Bogaert S, Peers K, Spriet A, Dankaerts W, Brumagne S, Depreitere B. A pre-, peri- and postoperative rehabilitation pathway for lumbar fusion surgery (REACT): a nonrandomized controlled clinical trial. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2025; 34:1513-1527. [PMID: 39956883 DOI: 10.1007/s00586-025-08706-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/14/2024] [Revised: 01/12/2025] [Accepted: 01/27/2025] [Indexed: 02/18/2025]
Abstract
PURPOSE To evaluate the effectiveness of an evidence-based pre-, peri- and postoperative rehabilitation pathway (i.e. the REACT rehabilitation pathway) on disability in patients undergoing lumbar fusion surgery (LFS), compared to usual care. METHODS A prospective, nonrandomized controlled trial included 72 patients scheduled for one- or two-level LFS for degenerative conditions or adult isthmic spondylolisthesis. Participants were allocated to usual care (N = 36) or the REACT rehabilitation pathway (N = 36). The REACT rehabilitation pathway includes prehabilitation, early mobilization and avoidance of unsubstantiated postoperative restrictions, early postoperative physiotherapy, patient empowerment, case manager guidance, and support towards an early return to activity. The primary outcome was disability; key secondary outcomes were back and leg pain intensity, and return-to-work rate. Additional secondary outcomes included fear of movement, pain catastrophizing, negative emotional states, sit-to-stand performance, analgesic use, length of stay, and adverse events. Data were collected preoperatively and at five time points up to one year postoperatively. RESULTS Participants in the REACT group demonstrated significantly greater improvements in disability (p = 0.003), back pain intensity (p = 0.007), and return-to-work rates (88% vs 56%, p = 0.34) compared to the control group. The REACT group also showed greater improvements in fear of movement (p = 0.038), pain catastrophizing (p < 0.001), combined negative emotional states (p = 0.007), sit-to-stand performance (p = 0.021), and reduced analgesic use (p = 0.001). No significant differences were observed in leg pain intensity (p = 0.042), length of hospital stay (p = 0.095) or adverse events (p = 1.00). CONCLUSION The REACT rehabilitation pathway significantly reduced disability in the first postoperative year after LFS compared to usual care. The most promising result is the significantly higher return-to-work rate in the REACT group.
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Affiliation(s)
- Liedewij Bogaert
- Universitair Ziekenhuis Leuven, Louvain, Belgium.
- Hasselt University, Hasselt, Belgium.
| | - Tinne Thys
- Universitair Ziekenhuis Leuven, Louvain, Belgium
| | | | | | | | - Lieven Moke
- Universitair Ziekenhuis Leuven, Louvain, Belgium
- KU Leuven, Louvain, Belgium
| | | | | | | | - Koen Peers
- Universitair Ziekenhuis Leuven, Louvain, Belgium
| | - Ann Spriet
- Universitair Ziekenhuis Leuven, Louvain, Belgium
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20
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Sarikonda A, Sami A, Self DM, Isch E, Zavitsanos A, Fuleihan AA, Khan A, Dougherty C, Quraishi D, Jallo J, Heller J, Prasad SK, Sharan A, Harrop J, Vaccaro AR, Sivaganesan A. Are Mildly Disabled Patients Appropriate for Spine Bundles? An Application of the Operative Value Index. World Neurosurg 2025; 196:123797. [PMID: 39983987 DOI: 10.1016/j.wneu.2025.123797] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2025] [Accepted: 02/10/2025] [Indexed: 02/23/2025]
Abstract
BACKGROUND Many studies have evaluated the effect of preoperative disability status on functional outcomes following spine surgery. However, no research has compared the "value" (outcomes per dollar spent) of surgery for patients with different levels of diagnosis-specific disability. METHODS We retrospectively reviewed 429 patients who underwent neurosurgical anterior cervical discectomy and fusion. Time-driven activity-based costing was used to calculate total intraoperative costs. Neck Disability Index (NDI) scores were recorded at baseline and 3 months postsurgery. Patients were categorized into groups based on their preoperative NDI score. Our primary outcome was a novel Operative Value Index (OVI), defined as the percent change in NDI per $1000 spent intraoperatively. Generalized linear mixed model regression was used to determine if severe-to-complete ("high") baseline neck disability was significantly associated with OVI and total cost. RESULTS Compared to patients with "high" preoperative neck disability, the OVI was significantly lower for patients with no neck disability (β-coefficient: -14.0; P < 0.001) and mild neck disability (β-coefficient: -4.06; P < 0.001). There were no significant associations between the NDI groups and total intraoperative cost. CONCLUSIONS Surgery provided the most value for patients with "high" baseline neck disability, with more favorable outcomes per dollar spent compared to those with low baseline neck disability. Patients with low baseline neck disability may therefore be suboptimal candidates for bundled payments, emphasizing the importance of careful patient selection to optimize resource use and outcomes in value-based care models.
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Affiliation(s)
- Advith Sarikonda
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
| | - Ashmal Sami
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - D Mitchell Self
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Emily Isch
- Department of General Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Alexander Zavitsanos
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Antony A Fuleihan
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Ayra Khan
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Conor Dougherty
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Danyal Quraishi
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Jack Jallo
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Joshua Heller
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Srinivas K Prasad
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Ashwini Sharan
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - James Harrop
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Alexander R Vaccaro
- Department of Orthopaedic Surgery, Rothman Orthopedic Institute, Philadelphia, Pennsylvania, USA
| | - Ahilan Sivaganesan
- Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
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Anitua E, Milani I, Martínez À, Cabello F, Prado R, Padilla S, Sanado L. A Long-Term Retrospective Observational Clinical Study Evaluating the Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Back Pain. Pain Ther 2025; 14:675-690. [PMID: 39821506 PMCID: PMC11914421 DOI: 10.1007/s40122-024-00699-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2024] [Accepted: 12/11/2024] [Indexed: 01/19/2025] Open
Abstract
INTRODUCTION Chronic back pain is a long-lasting disorder that is significantly associated with a reduction in the quality of life. Previously, the efficacy of intradiscal and epidural injections of plasma rich in growth factors (PRGF) was demonstrated at 6 months. The objective of this study was to retrospectively examine the medical records of these patients in order to determine whether the observed improvement at the 6-month follow-up was sustained over time. METHODS PRGF efficacy was evaluated using validated questionnaires: Core Outcome Measure Index (COMI) Pain score, COMI Disability score, COMI total score, and Oswestry Disability Index (ODI). Furthermore, an evaluation was conducted to determine whether the patients had undergone additional treatments. RESULTS the results demonstrated that 85.2% of the 27 patients who were enrolled exhibited sustained improvement across all scales over a median follow-up period of 24 months. The results of all questionnaires administered at 24 months exhibited statistically significant differences when compared to the baseline data (p < 0.01). Furthermore, there were no statistically significant differences between the results reported at 6 months and those at 24 months (p > 0.05). CONCLUSIONS the results of this retrospective study demonstrate that treatment of chronic back pain with PRGF was effective in maintaining pain reduction and improving function for at least 24 months after the end of treatment.
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Affiliation(s)
- Eduardo Anitua
- Eduardo Anitua Foundation for Biomedical Research, Vitoria, Spain.
- Regenerative Medicine Laboratory, BTI-Biotechnology Institute I MAS D, Vitoria, Spain.
- University Institute for Regenerative Medicine and Oral Implantology-UIRMI (UPV/EHU-Fundación Eduardo Anitua), Vitoria, Spain.
| | | | | | | | - Roberto Prado
- Eduardo Anitua Foundation for Biomedical Research, Vitoria, Spain
- Regenerative Medicine Laboratory, BTI-Biotechnology Institute I MAS D, Vitoria, Spain
- University Institute for Regenerative Medicine and Oral Implantology-UIRMI (UPV/EHU-Fundación Eduardo Anitua), Vitoria, Spain
| | - Sabino Padilla
- Eduardo Anitua Foundation for Biomedical Research, Vitoria, Spain
- Regenerative Medicine Laboratory, BTI-Biotechnology Institute I MAS D, Vitoria, Spain
- University Institute for Regenerative Medicine and Oral Implantology-UIRMI (UPV/EHU-Fundación Eduardo Anitua), Vitoria, Spain
| | - Luis Sanado
- Hospital Quirónsalud Vitoria, Vitoria, Spain
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22
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Prentice CLS, Flavell CA, Massy-Westropp N, Milanese S. Understanding responsiveness to an exercise intervention for people with persistent low back pain and lateral abdominal muscle impairments. A mixed methods study. Physiother Theory Pract 2025:1-21. [PMID: 40160008 DOI: 10.1080/09593985.2025.2484593] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2024] [Revised: 03/09/2025] [Accepted: 03/21/2025] [Indexed: 04/02/2025]
Abstract
BACKGROUND Exercise consistently demonstrates a small effect size for patients with persistent low back pain (PLBP). Determining patient characteristics that influence intervention responsiveness may improve treatment allocation and effect sizes. An exercise intervention for patients with PLBP and maladaptive changes in lateral abdominal muscle (LAM) contraction was recently trialed. OBJECTIVE To identify factors predicting responsiveness to an exercise intervention for patients with PLBP and why. METHODS This was a secondary mixed methods analysis of results from a feasibility randomized controlled trial with 50 participants. The 12-week program included individualized motor control and graded activity exercise. Regressions were performed to understand potential associations between characteristics (demographic, condition-specific signs and symptoms, compliance with exercise, and beliefs about exercise) and outcomes (pain, function, disability, and LAM contraction). Interview transcripts were analyzed for characteristics unique to participants that responded most and least to the intervention. Data was integrated for complementarity. RESULTS At baseline, females, participants with lower BMIs, decreased chronicity, fewer areas of pain, who had less previous interactions with healthcare professionals, and who were more positive about the potential for exercise to improve their pain had greater responsiveness (Adjusted R2 ranged from 0.17 to 0.66). During and after the program, increased physical activity levels was a positive predictor. CONCLUSION Responsiveness to the intervention may have been mediated by several baseline factors which may have affected participants' engagement with the intervention and continuation with exercise post intervention. Such characteristics may assist clinicians identifying whether this may be an appropriate intervention for patients with PLBP.
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Affiliation(s)
| | - Carol Ann Flavell
- College of Healthcare Sciences, James Cook University, Townsville, Australia
| | - Nicola Massy-Westropp
- Allied Health and Human Performance, University of South Australia, Adelaide, Australia
| | - Steve Milanese
- Department of Allied Health, Swinburne University of Technology, Hawthorn, Australia
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23
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Ferraro MC, Urquhart DM, Ferreira GE, Wewege MA, Abdel Shaheed C, Traeger AC, Hoving JL, Visser EJ, McAuley JH, Cashin AG. Antidepressants for low back pain and spine-related leg pain. Cochrane Database Syst Rev 2025; 3:CD001703. [PMID: 40058767 PMCID: PMC11890917 DOI: 10.1002/14651858.cd001703.pub4] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/08/2025]
Abstract
BACKGROUND Antidepressants are commonly used to treat low back pain and spine-related leg pain. However, their benefits and harms are uncertain. This is an update of a 2008 Cochrane review of antidepressants for non-specific low back pain. OBJECTIVES To assess the benefits and harms of antidepressants for non-specific low back pain and spine-related leg pain. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, and EU Clinical Trials Register from inception to 14 November 2024. SELECTION CRITERIA We included randomised controlled trials that compared antidepressants with placebo, usual care, or no treatment/waiting list. Participants were 18 years of age or older with non-specific low back pain or spine-related leg pain of any duration. We excluded participants with low back pain due to spinal fracture, inflammatory disease, aortic dissection, malignancy, or infection. Primary outcomes were pain intensity and disability, measured at short-term follow-up (> 4 to 14 weeks post-randomisation), and total adverse events. Secondary outcomes were serious adverse events, withdrawals due to adverse events, depressive symptoms, and health-related quality of life. DATA COLLECTION AND ANALYSIS Two review authors independently screened records to determine study inclusion, extracted data, and evaluated risk of bias using RoB 1 tool. Where possible, we conducted meta-analyses. We used GRADE to assess the certainty of evidence. MAIN RESULTS We included 26 randomised controlled trials. Eighteen studies included 2535 participants with non-specific low back pain, seven studies included 329 participants with spine-related leg pain, and one study included 68 participants with either condition. Most participants had pain lasting more than three months, with a mean duration between 18 months and 20 years. Mean ages ranged from 27 to 59 years. Studies evaluated serotonin and norepinephrine reuptake inhibitors (SNRIs; eight studies), selective serotonin reuptake inhibitors (SSRIs; two studies), tricyclic antidepressants (TCAs; 14 studies), tetracyclic antidepressants (TeCAs; two studies), or 'other antidepressants' (two studies). All studies were placebo-controlled. Outcomes were measured at short-term follow-up in 73% of studies. All included studies had at least one domain judged at high risk of bias, with 69% at high risk of attrition bias. Non-specific low back pain (benefits) Moderate-certainty evidence demonstrated that SNRIs probably have a small effect on pain intensity (mean difference (MD) (0 to 100 scale) -5.25, 95% confidence interval (CI) -7.17 to -3.34; I2 = 0; 4 studies, 1415 participants) and a trivial effect on disability (MD (0 to 24 scale) -0.91, 95% CI -1.30 to -0.51; I2 = 0; 4 studies, 1348 participants) at short-term follow-up. Low-certainty evidence showed that SSRIs may have little to no effect on pain intensity (MD 1.20, 95% CI -4.90 to 7.30; I2 = 0; 3 studies, 199 participants) and disability (MD -2.20 (0 to 100 scale), 95% CI -8.11 to 3.71; 1 study, 92 participants) at short-term follow-up. Moderate-certainty evidence demonstrated that TCAs probably have little to no effect on pain intensity (MD -2.00, 95% CI -7.25 to 3.24; I² = 31%; 4 studies, 417 participants), but probably have a small effect on disability (MD (0 to 24 scale) -1.76, 95% CI -2.70 to -0.82; I2 = 0; 3 studies, 330 participants) at short-term follow-up. The effects of TeCAs (MD -4.50, 95% CI -17.59 to 8.59; 1 study, 52 participants) and other antidepressants (MD -5.40, 95% CI -23.08 to 12.28; 1 study, 39 participants) on pain intensity at short-term follow-up are unclear (very low-certainty evidence). No studies assessed the effects of TeCAs or other antidepressants on disability. Spine-related leg pain (benefits) The effects of SNRIs on pain intensity (MD -46.10, 95% CI -89.29 to -2.91; 1 study, 11 participants) and disability (MD (0 to 100 scale) -4.40, 95% CI -20.25 to 11.45; 1 study, 11 participants) at short-term follow-up are very uncertain (very low-certainty evidence). Low-certainty evidence showed TCAs may have a large effect on pain intensity at short-term follow-up (MD -23.00, 95% CI -32.12 to -13.88; 1 study, 60 participants), and a moderate effect on disability (MD (0 to 100 scale) -13.00, 95% CI -19.42 to -6.58; 1 study, 60 participants). There were no studies that assessed the effects of SSRIs, TeCAs, or other antidepressants in people with spine-related leg pain. Non-specific low back pain and spine-related leg pain (harms) Moderate-certainty evidence demonstrated that SNRIs probably increase the risk of adverse events (risk ratio (RR) 1.17, 95% CI 1.07 to 1.27; I2 = 0%; 5 studies, 1510 participants), but it is unclear whether they increase the risk of serious adverse events (Peto odds ratio (OR) 1.75, 95% CI 0.79 to 3.89; 5 studies, 1510 participants; very low-certainty evidence). It is unclear whether TCAs increase the risk of adverse events (RR 1.76, 95% CI 0.79 to 3.90; 7 studies, 474 participants; low-certainty evidence) or serious adverse events (Peto OR 6.64, 95% CI 0.41 to 106.72; I² = 0%; 1 study, 142 participants; very low-certainty evidence). It is unclear whether SSRIs (RR 1.83, 95% CI 0.14 to 24.19; I² = 95%; 2 studies, 107 participants; very low-certainty evidence) or TeCAs increase the risk of adverse events (RR 0.93, 95% CI 0.79 to 1.09; 1 study, 52 participants; very low-certainty evidence). No studies assessed the risk of serious adverse events for these classes. No studies measured total adverse events for other antidepressants. It is unclear whether other antidepressants increase the risk of serious adverse events (Peto OR 0.90, 95% CI 0.16 to 4.96; 1 study, 42 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS We found that in people with non-specific low back pain, SNRIs probably have small effects on pain intensity, trivial effects on disability, and are probably associated with adverse effects. TCAs probably do not reduce low back pain intensity, but may have a small effect on disability. The effects of antidepressants on spine-related leg pain are uncertain, though SNRIs and TCAs might be prioritised over other classes for future investigations. Evidence for the safety of SSRIs, TCAs, TeCAs, and other antidepressants in non-specific low back pain and spine-related leg pain remains unclear.
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Affiliation(s)
- Michael C Ferraro
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
- School of Health Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia
| | - Donna M Urquhart
- School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
| | - Giovanni E Ferreira
- Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia
- Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
| | - Michael A Wewege
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
- School of Health Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia
| | - Christina Abdel Shaheed
- Institute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
| | - Adrian C Traeger
- Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia
- Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
| | - Jan L Hoving
- Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands
| | - Eric J Visser
- School of Medicine, University of Notre Dame Australia, Fremantle, Australia
| | - James H McAuley
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
- School of Health Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia
| | - Aidan G Cashin
- Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
- School of Health Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia
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Klukowska AM, Dol MG, Vandertop WP, Schröder ML, Staartjes VE. Estimating the minimum clinically important difference (MCID) of the five-repetition sit-to-stand test in patients with lumbar disc herniation. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2025; 34:1107-1114. [PMID: 39680122 DOI: 10.1007/s00586-024-08582-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/26/2024] [Revised: 10/06/2024] [Accepted: 11/18/2024] [Indexed: 12/17/2024]
Abstract
BACKGROUND The impact of surgical interventions on lumbar disc herniation (LDH) is often assessed using objective functional impairment (OFI) tests like the five-repetition sit-to-stand (5R-STS) test. This study calculates the minimum clinically important difference (MCID) for 5R-STS improvement in patients with LDH one year after surgery. METHODS Adult patients with LDH scheduled for surgery were prospectively recruited from a Dutch short-stay spinal clinic. The 5R-STS time, Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), Numeric Rating Scale for back and leg pain, EQ-5D-3L health-related quality of life questionnaire and EQ5D-VAS were recorded preoperatively, at 6-weeks and 1-year post-operatively. The MCID was calculated using anchor-based methods (within-patient change; between-patient change; and receiver-operating characteristic approaches) and distribution-based methods (0.5 standard deviation (SD); effect size; standard error of measurement; standardized response mean; and 95% minimum detectable change (MDC)). The final MCID value was based on the "gold standard": an averaging of the anchor-based methods using ODI and RMDQ as the closest available anchors. RESULTS We prospectively recruited 134 patients. One-year follow-up was completed by 103 (76.8%) of patients. The MCID values derived using different methods varied from 0.7 to 5.1 s (s). The final, averaged, anchor-based MCID for improvement was 3.6 s. Within distribution-based methods, 95% MDC and 0.5SD approach, yielded an MCID of 3.0 and 3.8 s, respectively, aligning closely with the overall anchor-derived MCID for 5R-STS. CONCLUSION In a patient with LDH, an improvement in 5R-STS performance of at least 3.6 s can be regarded as a clinically relevant improvement.
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Affiliation(s)
- Anita M Klukowska
- Department of Neurosurgery, Bergman Clinics, Amsterdam, The Netherlands
- Amsterdam UMC, Neurosurgery, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
- Department of Neurosurgery, Medical University of Bialystok, Bialystok, Poland
| | - Manon G Dol
- Department of Neurosurgery, Bergman Clinics, Amsterdam, The Netherlands
| | - W Peter Vandertop
- Amsterdam UMC, Neurosurgery, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Marc L Schröder
- Department of Neurosurgery, Bergman Clinics, Amsterdam, The Netherlands
| | - Victor E Staartjes
- Machine Intelligence in Clinical Neuroscience and Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland.
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Lim YZ, Urquhart DM, Wang Y, Estee MM, Wluka AE, Heritier S, Cicuttini FM. Metformin for low back pain: Study protocol for a randomised, double-blind, placebo-controlled trial. OSTEOARTHRITIS AND CARTILAGE OPEN 2025; 7:100486. [PMID: 39811692 PMCID: PMC11732449 DOI: 10.1016/j.ocarto.2024.100486] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/11/2024] [Accepted: 05/07/2024] [Indexed: 01/16/2025] Open
Abstract
Background Chronic low back pain is a major cause of pain and disability with limited effective therapies. Metformin is a safe, inexpensive, well-tolerated drug that has pleotropic effects, including effects on pain pathways that may influence low back pain. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces low back pain over 4 months in individuals with chronic low back pain. Methods and analysis One hundred and twenty-three participants with chronic low back pain will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2g or identical placebo daily for 4 months. The primary outcome will be change in pain intensity assessed using a 100 mm visual analogue scale at 4 months and the secondary outcomes will be change in low back disability, physical activity and narcotic use. Adverse events will be recorded. The primary analysis will be by intention to treat. Discussion Given the societal burden of LBP and the limited effective treatment options available, this study that evaluates the efficacy of metformin in LBP, if proves to be effective, will offer an important therapeutic approach for this disabling condition. Ethics and dissemination Ethics approval has been obtained from the Alfred Hospital Ethics Committee (392/21) and Monash University Human Research Ethics Committee (30607). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12621001453875 (registered 25th October 2021).
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Affiliation(s)
| | | | - Yuanyuan Wang
- School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia
| | - Mahnuma Mahfuz Estee
- School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia
| | - Anita E. Wluka
- School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia
| | - Stephane Heritier
- School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia
| | - Flavia M. Cicuttini
- School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia
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Breugelmans L, Smeets RJEM, Köke AJA, Winkens B, Oosterwijk RFA, Beckers LWME. Outpatient interdisciplinary multimodal pain treatment programme for patients with chronic musculoskeletal pain: a longitudinal cohort study. Disabil Rehabil 2025; 47:1114-1125. [PMID: 38910313 DOI: 10.1080/09638288.2024.2364822] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2023] [Revised: 05/03/2024] [Accepted: 05/24/2024] [Indexed: 06/25/2024]
Abstract
PURPOSE To describe the outcomes of an interdisciplinary multimodal pain treatment (IMPT) for chronic musculoskeletal pain (CMP) patients up until 12 months post-treatment. MATERIALS AND METHODS Data were gathered during routine clinical practice during a 3-year period (2019-2021) at six Dutch rehabilitation centres. Assessments included patient-reported outcome measures for multiple domains including disability, pain and fatigue. Longitudinal data were analysed using repeated-measures models and by quantifying responder rates. RESULTS Included were 2309 patients with a mean age of 43.7 (SD 12.9) years, of which 73% female. All outcomes showed significant improvements at each timepoint. At discharge, large effect sizes were found for disability, average and worst pain, fatigue and health-related quality of life. Improvements were largely sustained at 12-months. Relatively large proportions of patients had clinically relevant improvements after treatment (pain-related disability: 60%; average pain: 52%; worst pain: 37.4%; work capacity: 50%; concentration: 50%; fatigue: 46%). Patients who received a treatment extension showed further improvements for all outcome measures, except average pain. CONCLUSIONS At group level, all outcomes significantly improved with mainly large effect sizes. The results were mostly sustained. The proportion of patients showing clinically relevant improvements tends to be larger than previously reported for mixed CMP patients.
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Affiliation(s)
- L Breugelmans
- Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands
| | - R J E M Smeets
- Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands
- CIR Clinics in Revalidatie, Netherlands
- Pain in Motion International Research Group (PiM), Maastricht, Netherlands
| | - A J A Köke
- Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands
- Pain in Motion International Research Group (PiM), Maastricht, Netherlands
| | - B Winkens
- Methodology & Statistics, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Life Sciences and Medicine, Maastricht University, Maastricht, Netherlands
| | | | - L W M E Beckers
- Department of Rehabilitation Medicine, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands
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Caduda SDS, Andrade TS, Menezes MA, Leite Dos Santos Moraes T, Silva IB, Pereira de Farias Neto J, Monteiro da Silva Junior W. Is physical exercise effective in improving pain, functional mobility and quality of life in individuals with hip osteoarthritis? A systematic review with meta-analysis. J Bodyw Mov Ther 2025; 41:121-130. [PMID: 39663077 DOI: 10.1016/j.jbmt.2024.11.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2023] [Revised: 10/25/2024] [Accepted: 11/02/2024] [Indexed: 12/13/2024]
Abstract
OBJECTIVE To evaluate the effectiveness of physical exercise and its implications on pain, functional mobility (FM) and quality of life (QoL) in individuals with isolated hip osteoarthritis (HO). DESIGN Intervention systematic review. LITERATURE SEARCH Pubmed, Embase, CINAHL, CENTRAL (Cochrane) and PEDro were searched for studies evaluating the effect of exercise on pain, FM and QoL in people with HO from the first publication until August 2022. STUDY SELECTION CRITERIA Two reviewers independently assessed studies for inclusion and quality of evidence. We included randomized controlled trials on HO where the intervention was physical exercise compared with the control group (exercise different from the intervention or no intervention). DATA SYNTHESIS Available data were analyzed using meta-analysis when comparison was possible. Otherwise, the data were synthesized qualitatively. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS Seven trials were identified. Low-quality evidence indicated that there was no significant difference between the mixed exercise versus no intervention groups in the meta-analysis for pain and QoL in short term. Low-quality evidence indicated that low-intensity resistance exercise showed a statistically significant difference when compared to high-intensity resistance exercise in terms of pain, and very low-quality evidence indicated that there was no significant difference regarding functional mobility, both in short term. CONCLUSION New clinical trials with methodological rigor should be carried out to investigate the effectiveness of physical exercise in individuals with HO and which is the most effective modality in pain, FM and QoL for future clinical decision-making.
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Affiliation(s)
- Suziany Dos Santos Caduda
- Health Sciences Graduate Program. Federal University of Sergipe (PPGCS-UFS), Rua Claudio Batista s/n, Aracaju, Sergipe, Brazil, CEP: 49060-100.
| | - Talita Santos Andrade
- Health Sciences Graduate Program. Federal University of Sergipe (PPGCS-UFS), Rua Claudio Batista s/n, Aracaju, Sergipe, Brazil, CEP: 49060-100
| | - Mayara Alves Menezes
- Health Sciences Graduate Program. Federal University of Sergipe (PPGCS-UFS), Rua Claudio Batista s/n, Aracaju, Sergipe, Brazil, CEP: 49060-100
| | | | - Igor Borges Silva
- Health Sciences Graduate Program. Federal University of Sergipe (PPGCS-UFS), Rua Claudio Batista s/n, Aracaju, Sergipe, Brazil, CEP: 49060-100
| | | | - Walderi Monteiro da Silva Junior
- Health Sciences Graduate Program. Federal University of Sergipe (PPGCS-UFS), Rua Claudio Batista s/n, Aracaju, Sergipe, Brazil, CEP: 49060-100; Graduate Program in Physical Education, Federal University of Sergipe (PPGEF-UFS), São Cristovão, 49100-000, SE, Brazil; Department of Physiotherapy, Federal University of Sergipe (UFS), São Cristovão, 49100-000, SE, Brazil
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Yu D, Wu M, Zhang J, Song W, Zhu L. Effect of qigong on pain and disability in patients with chronic non-specific low back pain: a systematic review and meta-analysis of randomized controlled trials. J Orthop Surg Res 2025; 20:194. [PMID: 39994723 PMCID: PMC11849339 DOI: 10.1186/s13018-025-05576-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Accepted: 02/05/2025] [Indexed: 02/26/2025] Open
Abstract
BACKGROUND Chronic non-specific low back pain (CNLBP) is a common health problem worldwide. Patients with CNLBP often suffer from persistent pain, with a few being disabled by their pain, affecting their daily functioning and social participation. This study aims to systematically evaluate the effects of pain and dysfunction in Qigong patients with chronic non-specific back pain through systematic evaluation and gathered analysis of random control test data. METHODS We searched nine databases from their inception dates until April 2024. Relevant randomized controlled trials (RCTs) were included. Patients were assessed for pain using the Visual Analog Scale and Numeric Pain Rating Scale and for disability using the Oswestry Disability Index and Roland-Morris disability questionnaire. The risk of bias was assessed using the Cochrane Collaboration tool. CMA V3.0 was used to analyze data. RESULTS Sixteen RCTs involving 1175 participants were included. These studies have different designs, and the participants are mainly around 60 years old. The results showed that the qigong practice improved pain significantly more than the control measures ([Mean Difference MD] = - 1.34, 95% confidence intervals [CI] - 1.76 to - 0.92, p < 0.001 Minimal Clinically Important Differences MCID = 1.5), and the efficacy of short-term interventions (MD = - 1.88, 95% CI - 2.87 to - 0.9, p < 0.001) was superior to that of long-term interventions (MD = - 1.07, 95% CI - 1.49 to - 0.65, p < 0.001). For improvement in the degree of dysfunction, qigong practice showed a higher effect size (MD = - 5.88, 95% CI - 7.98 to - 3.78, p < 0.001 MCID = 5) than that observed in the control group. CONCLUSION Qigong practice is effective in improving disability in patients with CNLBP, but has no significant effect on improving pain. However, due to the high heterogeneity, the results need to be interpreted with caution.
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Affiliation(s)
- Donghui Yu
- Heilongjiang University of Chinese Medicine, Harbin, China
| | - Minmin Wu
- Heilongjiang University of Chinese Medicine, Harbin, China
| | | | - Wenjing Song
- Heilongjiang University of Chinese Medicine, Harbin, China
| | - Luwen Zhu
- The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China.
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Verheijen EJA, van der Vlist NRE, Bartels EC, van Haagen OBHAM, Vleggeert-Lankamp CLA. The effect of a transforaminal epidural injection in patients with lumbar disc herniation is not correlated with the presence of type II modic changes. BRAIN & SPINE 2025; 5:104222. [PMID: 40115868 PMCID: PMC11925183 DOI: 10.1016/j.bas.2025.104222] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 11/14/2024] [Revised: 02/13/2025] [Accepted: 02/24/2025] [Indexed: 03/23/2025]
Abstract
Introduction Transforaminal epidural steroid injections (TEI) have been suggested to alleviate symptoms in patients with lumbar disc herniation (LDH) through its anti-inflammatory effect. However, treatment effect varies among patients and reliable predictors are lacking. Modic changes (MC) are also associated with inflammatory processes and, therefore, we hypothesize that MC may be correlated with outcome after TEI. Research question To investigate the correlation between the presence of MC at the level of LDH and the effect of TEI. Material and methods Patients with unilateral lumbar radiculopathy secondary to LDH undergoing TEI were included. MC was graded by two independent assessors. Outcome measures included leg pain, back pain, disability and patient-received recovery at baseline, 30 min, 2 weeks and 6 weeks after treatment. Multivariate analysis was performed for all outcomes and for dichotomized scores using a cutoff of ≥30% improvement. A p-value of ≤0.05 was considered statistically significant. Results A total of 88 patients were included of whom 52.3% demonstrated MC. The vast majority was classified as type II (94%). The presence of MC was not correlated with any outcome measure when correcting for age, gender, duration of symptoms and the use of analgesics, nor for dichotomized scores. Discussion and conclusion The findings indicate that type II MC is not associated with outcome within six weeks after TEI. Therefore, type II MC cannot be used as a predictor for TEI outcome. Future studies should include longer follow-up and investigate the correlation between the type of MC and the effect of TEI.
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Affiliation(s)
- E J A Verheijen
- Department of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands
- Department of Neurosurgery, Spaarne Hospital, Hoofddorp, Haarlem, the Netherlands
| | - N R E van der Vlist
- Department of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands
- Department of Neurosurgery, Spaarne Hospital, Hoofddorp, Haarlem, the Netherlands
| | - E C Bartels
- Department of Anesthesiology, Spaarne Hospital, Hoofddorp, Haarlem, the Netherlands
| | - O B H A M van Haagen
- Department of Anesthesiology, Spaarne Hospital, Hoofddorp, Haarlem, the Netherlands
| | - C L A Vleggeert-Lankamp
- Department of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands
- Department of Neurosurgery, Spaarne Hospital, Hoofddorp, Haarlem, the Netherlands
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30
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Wang X, Martin G, Sadeghirad B, Chang Y, Florez ID, Couban RJ, Mehrabi F, Crandon HN, Esfahani MA, Sivananthan L, Sengupta N, Kum E, Rathod P, Yao L, Morsi RZ, Genevay S, Buckley N, Guyatt GH, Rampersaud YR, Standaert CJ, Agoritsas T, Busse JW. Common interventional procedures for chronic non-cancer spine pain: a systematic review and network meta-analysis of randomised trials. BMJ 2025; 388:e079971. [PMID: 39971346 DOI: 10.1136/bmj-2024-079971] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/21/2025]
Abstract
OBJECTIVE To address the comparative effectiveness of common interventional procedures for chronic non-cancer (axial or radicular) spine pain. DESIGN Systematic review and network meta-analysis (NMA) of randomised controlled trials (RCTs). DATA SOURCES Medline, Embase, CINAHL, CENTRAL, and Web of Science from inception to 24 January 2023. STUDY SELECTION RCTs that enrolled patients with chronic non-cancer spine pain, randomised to receive a commonly used interventional procedure versus sham procedure, usual care, or another interventional procedure. DATA EXTRACTION AND SYNTHESIS Pairs of reviewers independently identified eligible studies, extracted data, and assessed risk of bias. We conducted frequentist network meta-analyses to summarise the evidence and used the GRADE approach to rate the certainty of evidence. RESULTS Of 132 eligible studies, 81 trials with 7977 patients that explored 13 interventional procedures or combinations of procedures were included in meta-analyses. All subsequent effects refer to comparisons with sham procedures. For chronic axial spine pain, the following probably provide little to no difference in pain relief (moderate certainty evidence): epidural injection of local anaesthetic (weighted mean difference (WMD) 0.28 cm on a 10 cm visual analogue scale (95% CI -1.18 to 1.75)), epidural injection of local anaesthetic and steroids (WMD 0.20 (-1.11 to 1.51)), and joint-targeted steroid injection (WMD 0.83 (-0.26 to 1.93)). Intramuscular injection of local anaesthetic (WMD -0.53 (-1.97 to 0.92)), epidural steroid injection (WMD 0.39 (-0.94 to 1.71)), joint-targeted injection of local anaesthetic (WMD 0.63 (-0.57 to 1.83)), and joint-targeted injection of local anaesthetic with steroids (WMD 0.22 (-0.42 to 0.87)) may provide little to no difference in pain relief (low certainty evidence); intramuscular injection of local anaesthetic with steroids may increase pain (WMD 1.82 (-0.29 to 3.93)) (low certainty evidence). Evidence for joint radiofrequency ablation proved of very low certainty.For chronic radicular spine pain, epidural injection of local anaesthetic and steroids (WMD -0.49 (-1.54 to 0.55)) and radiofrequency of dorsal root ganglion (WMD 0.15 (-0.98 to 1.28)) probably provide little to no difference in pain relief (moderate certainty evidence). Epidural injection of local anaesthetic (WMD -0.26 (-1.37 to 0.84)) and epidural injection of steroids (WMD -0.56 (-1.30 to 0.17)) may result in little to no difference in pain relief (low certainty evidence). CONCLUSION Our NMA of randomised trials provides low to moderate certainty evidence that, compared with sham procedures, commonly performed interventional procedures for axial or radicular chronic non-cancer spine pain may provide little to no pain relief. REGISTRATION PROSPERO (CRD42020170667).
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Affiliation(s)
- Xiaoqin Wang
- Michael G DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
- University of Ottawa Heart Institute, Ottawa, Ontario, Canada
| | - Grace Martin
- Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
| | - Behnam Sadeghirad
- Michael G DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
- Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
| | - Yaping Chang
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
| | - Ivan D Florez
- Department of Pediatrics, Universidad de Antioquia, Medellin, Colombia
- School of Rehabilitation Science, McMaster University, Hamilton, Canada
- Pediatric Intensive Care Unit, Clínica Las Americas, Medellin, Colombia
| | - Rachel J Couban
- Michael G DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
- Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
| | - Fatemeh Mehrabi
- HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
- Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA
| | - Holly N Crandon
- Michael G DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
| | | | | | - Neil Sengupta
- Department of Medicine, Division of Emergency Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Elena Kum
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
- Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - Preksha Rathod
- Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
| | - Liang Yao
- Michael G DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
- Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Singapore
| | - Rami Z Morsi
- Department of Neurology, University of Chicago, Chicago, Illinois, USA
| | - Stéphane Genevay
- Department of Rheumatology, Geneva University Hospitals, Geneva, Switzerland
| | - Norman Buckley
- Michael G DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
- Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
- Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - Gordon H Guyatt
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
| | - Y Raja Rampersaud
- Schroeder Arthritis Institute, Krembil Research Institute, Division of Orthopaedics, University Health Network, Toronto, Ontario, Canada
- Department of Surgery, University of Toronto, Toronto, Ontario, Canada
| | - Christopher J Standaert
- Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA
| | - Thomas Agoritsas
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
- Division General Internal Medicine, University Hospitals of Geneva, Geneva, Switzerland
- The MAGIC Evidence Ecosystem Foundation, Oslo, Norway
| | - Jason W Busse
- Michael G DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada
- Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
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Hatakka J, Laaksonen I, Kostensalo J, Mäkelä KT, Salo H, Pernaa K. 1-year results of lumbar spinal stenosis surgery in Finland: a national FinSpine register study. Acta Orthop 2025; 96:154-160. [PMID: 39950642 PMCID: PMC11829219 DOI: 10.2340/17453674.2025.42849] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Accepted: 12/22/2024] [Indexed: 02/17/2025] Open
Abstract
BACKGROUND AND PURPOSE While the rates of lumbar spinal stenosis (LSS) surgery have increased continuously internationally, the role of fusion surgery in the treatment of LSS has been under debate. We aimed to assess the outcome of LSS surgery at 1 year postoperatively and to compare decompression surgery with or without fusion based on the Finnish national spine register FinSpine data. METHODS FinSpine data of surgically treated LSS from 2015 to 2022 was included. The primary outcome was Oswestry Disability Index (ODI), and secondary ones were Visual Analogue Scale for leg and back pain. Predetermined minimal clinically important difference (MCID) for all outcome measures was used to assess the clinical significance of differences in outcomes. Propensity score matching was utilized to ensure that the treatment groups were comparable. RESULTS There were 8,647 LSS patients in the data, of whom 6,751 (77%) were the subject of decompression surgery. Over 90% of patients without spondylolisthesis received decompression alone. At 1-year follow-up, ODI was on average 20.6 (95% confidence interval [CI] 19.3-21.9]) for the fusion group and 23.3 (CI 22.5-24.0) for the decompression group. Differences in ODI, VAS leg pain, or VAS back pain were below the MCID. The share of patients reaching ODI percentage change score ≥ 30% was 74% (CI 71-78) in the fusion group and 66% (CI 63-68) in the decompression group. CONCLUSION Most of the LSS patients experienced significant improvement after LSS surgery. We found no clinical differences between decompression surgery with and without fusion.
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Affiliation(s)
- Juho Hatakka
- Department of Orthopaedics and Traumatology, Turku University Hospital, and University of Turku, Turku, Finland.
| | - Inari Laaksonen
- Department of Orthopaedics and Traumatology, Turku University Hospital, and University of Turku, Turku, Finland
| | - Joel Kostensalo
- Natural Resources Institute Finland, Natural Resources, Joensuu, Finland
| | - Keijo T Mäkelä
- Department of Orthopaedics and Traumatology, Turku University Hospital, and University of Turku, Turku, Finland
| | - Henri Salo
- Knowledge Brokers Department, Finnish Institute for Health and Welfare, Helsinki, Finland
| | - Katri Pernaa
- Department of Orthopaedics and Traumatology, Turku University Hospital, and University of Turku, Turku, Finland
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Zhang Z, Zhang Z, Zheng B, Yang Y, Sun Y. Effects of lower limb strengthening training on lower limb biomechanical characteristics and knee pain in patients with patellofemoral pain: a systematic review and meta-analysis. Eur J Med Res 2025; 30:90. [PMID: 39923086 PMCID: PMC11807312 DOI: 10.1186/s40001-025-02347-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/01/2024] [Accepted: 01/30/2025] [Indexed: 02/10/2025] Open
Abstract
The objective of this study was to conduct a comprehensive comparison of the effects of hip and knee strengthening training in patients with patellofemoral pain (PFP). A meta-analysis was conducted to investigate the effects of these two types of strengthening training on patients' lower limb biomechanics, knee pain and function. The aim was to evaluate the effectiveness of the two training modalities and provide evidence-based recommendations for the rehabilitation of patients with PFP. A total of 12 studies were identified through a search of the Web of Science, EBSCO, and PubMed databases. The selected studies comprised nine randomized controlled trials (RCTs), one comparative controlled trial (CCTs) and two cohort studies (CSs), with a total of 1,066 patients. The quality of the included studies was evaluated via the PEDro scale, and a meta-analysis was conducted via Stata18 software. The results show that both types of strengthening training positively impact pain reduction and improved knee function in PFP patients. Moderate evidence from meta-analyses indicated that hip strengthening training (SMD = -1.740, 95%; CI -2.212 to -1.267, P < 0.001) was more effective than knee strengthening training (SMD = -1.302, 95%; CI -1.75 to -0.86, P < 0.001) in reducing pain (VAS). Similarly, Strong evidence suggests that hip strengthening training (SMD = 1.205, 95%; CI 0.968 to 1.443, P < 0.001) was significantly more effective than knee strengthening training (SMD = 1.023, 95%; CI 0.722 to 1.325, P < 0.001) in improving knee function (AKPS). Additionally, moderate evidence suggests that hip strengthening training significantly increased hip abductor strength (SMD = 0.848, 95%; CI 0.508-1.187, P < 0.001) and external rotator strength (SMD = 0.780, 95%; CI 0.416-1.145, P < 0.001), while strong evidence suggests that knee strengthening training did not significantly enhance knee extensor strength (SMD = 0.212, 95%; CI -0.014 to 0.439, P = 0.066). Therefore, clinicians should use hip strengthening as one of the primary training interventions when treating patients with PFP.
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Affiliation(s)
- Zeyang Zhang
- College of Physical Education and Health, East China Normal University, Shanghai, 200241, China
- Key Laboratory of Adolescent Health Assessment and Exercise Intervention of Ministry of Education, East China Normal University, Shanghai, 200241, China
| | - Zeyi Zhang
- College of Physical Education and Health, East China Normal University, Shanghai, 200241, China
- Key Laboratory of Adolescent Health Assessment and Exercise Intervention of Ministry of Education, East China Normal University, Shanghai, 200241, China
| | - Bosong Zheng
- College of Physical Education and Health, East China Normal University, Shanghai, 200241, China
- Key Laboratory of Adolescent Health Assessment and Exercise Intervention of Ministry of Education, East China Normal University, Shanghai, 200241, China
| | - Yuhang Yang
- Department of Physical Education, College of Education, Zhejiang University, Hangzhou, 310058, China
| | - Youping Sun
- College of Physical Education and Health, East China Normal University, Shanghai, 200241, China.
- Key Laboratory of Adolescent Health Assessment and Exercise Intervention of Ministry of Education, East China Normal University, Shanghai, 200241, China.
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Ballester Herrera MA, Muñoz Vives JM, Marti A. Clinical Evolution and Safety of a Cryotherapy - Based Spray for Mild to Moderate Joint and Muscle Pain: A Descriptive Observational Study. Int J Sports Phys Ther 2025; 20:243-252. [PMID: 39959416 PMCID: PMC11830277 DOI: 10.26603/001c.128589] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/23/2024] [Accepted: 12/14/2024] [Indexed: 02/18/2025] Open
Abstract
Background Cryotherapy, long used for its pain-relieving and anti-inflammatory effects, is widely applied in sports medicine, physiotherapy, and postoperative care. Advances in cryotherapy methods, including the use of topical vapocoolant sprays, offer enhanced pain management and support recovery from musculoskeletal injuries by alleviating pain and reducing swelling in a targeted manner. Hypothesis/Purpose The primary aim was to assess both immediate and sustained pain relief in subjects with mild to moderate musculoskeletal complaints. Study Design Observational cohort study. Methods Fifty-nine participants with mild to moderate musculoskeletal pain participated in a three-week observational study evaluating a cryotherapy spray. Pain and range of motion (ROM) were assessed using the Visual Analogue Scale (VAS) and goniometer measurements at multiple time points, including T-1 (before treatment), T0 (beginning of treatment), T2-min, T5-min, T10-min, T15-min, T30-min, T60-min, T7-days, T14-days, while participants were actively receiving treatment exclusively with the cryotherapy spray, and T21-days (1 week after treatment cessation). Acceptability Test and additional subjective questionnaires evaluated participants analysis of cooling sensation and product tolerance. Data were analyzed using Cumulative Logit Mixed Models (CLMM) and the non-parametric Friedman test for repeated measures. Results The cryotherapy spray significantly reduced pain (VAS) from baseline (p < 0.001, Hedges' g = -1.90) and improved joint mobility (ROM) with derived scores increasing from 3 (3-4) to 4 (4-4) by Day 21 (p < 0.001). Rapid pain relief was reported by 35% of participants within 10 seconds, with 80% experiencing relief within three minutes. Comfort ratings were consistently high, with 95% of participants expressing satisfaction at Day 0, rising to 99% by Day 14. Global efficacy satisfaction measured by a subjective Likert scale also increased from 75% at baseline to 95% by Day 14. No adverse events were reported. Conclusion This study supports the effectiveness of the cryotherapy spray in reducing pain and improving joint mobility, with both immediate and sustained benefits. High patient satisfaction and a favorable safety profile suggest its potential for clinical use. Further controlled studies could confirm its efficacy in broader populations. Level of Evidence Level 3.
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Maras G, Olmez SB, Degerli Maras B, Citaker S. The Turkish minimum dataset for chronic low back pain research: a cross-cultural adaptation of the National Institutes of Health Task Force Research Standards. Physiother Theory Pract 2025; 41:309-316. [PMID: 38566565 DOI: 10.1080/09593985.2024.2337789] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2023] [Revised: 01/25/2024] [Accepted: 03/26/2024] [Indexed: 04/04/2024]
Abstract
BACKGROUND The US National Institutes of Health (NIH) has produced a minimal data set to promote more accurate and consistent reporting of clinical trials, facilitating easier comparison of research on low back pain patients worldwide. The NIH-minimal dataset has not been previously translated into Turkish, and its features are currently unknown. This study aimed to adapt the NIH-Minimal Data Set into Turkish and investigate its validity and reliability in Turkish-speaking patients with chronic low back pain (CLBP). METHODS In the study, 245 patients with CLBP were included. Test-retest and internal consistency analyzes were performed to evaluate the reliability of the NIH-minimal dataset. The intraclass correlation coefficient (ICC2,1) value was used to assess test-retest analysis. Cronbach's alpha value was calculated for internal consistency. Total impact scores of the NIH-minimal dataset were compared with total scores of the Roland Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI) to assess construct validity. The minimal detectable change (MDC95) was calculated based on the standard error of measurement (SEM95). RESULTS The NIH-Minimal Data Set was found to have high test-retest reliability (ICC2,1 = 0.928) and high internal consistency (Cronbach α = 0.905). The NIH-minimal dataset correlated well with RMDQ and ODI (r = 0.750 and 0.810, respectively). There were no floor or ceiling effects. Also, SEM95 and MDC95 for the total score were 4.57 and 12.55, respectively. CONCLUSION Considering all these data, it was concluded that the Turkish version of the NIH-minimal dataset is a valid and reliable outcome measure for evaluating patients with CLBP.
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Affiliation(s)
- Gokhan Maras
- Faculty of Health Science, Department of Physical Therapy and Rehabilitation, Amasya University, Amasya, Turkey
| | - Sevim Beyza Olmez
- Faculty of Health Science, Department of Physical Therapy and Rehabilitation, Karamanoğlu Mehmetbey University, Karaman, Turkey
| | | | - Seyit Citaker
- Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Gazi University, Ankara, Turkey
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Nim C, Aspinall SL, Cook CE, Corrêa LA, Donaldson M, Downie AS, Harsted S, Hansen S, Jenkins HJ, McNaughton D, Nyirö L, Perle SM, Roseen EJ, Young JJ, Young A, Zhao GH, Hartvigsen J, Juhl CB. The Effectiveness of Spinal Manipulative Therapy in Treating Spinal Pain Does Not Depend on the Application Procedures: A Systematic Review and Network Meta-analysis. J Orthop Sports Phys Ther 2025; 55:109-122. [PMID: 39869665 DOI: 10.2519/jospt.2025.12707] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/29/2025]
Abstract
OBJECTIVE: To assess whether spinal manipulative therapy (SMT) application procedures (ie, target, thrust, and region) impacted changes in pain and disability for adults with spine pain. DESIGN: Systematic review with network meta-analysis. LITERATURE SEARCH: We searched PubMed and Epistemonikos for systematic reviews indexed up to February 2022 and conducted a systematic search of 5 databases (MEDLINE, EMBASE, CENTRAL [Cochrane Central Register of Controlled Trials], PEDro [Physiotherapy Evidence Database], and Index to Chiropractic Literature) from January 1, 2018, to September 12, 2023. We included randomized controlled trials (RCTs) from recent systematic reviews and newly identified RCTs published during the review process and employed artificial intelligence to identify potentially relevant articles not retrieved through our electronic database searches. STUDY SELECTION CRITERIA: We included RCTs of the effects of high-velocity, low-amplitude SMT, compared to other SMT approaches, interventions, or controls, in adults with spine pain. DATA SYNTHESIS: The outcomes were spinal pain intensity and disability measured at short-term (end of treatment) and long-term (closest to 12 months) follow-ups. Risk of bias (RoB) was assessed using version 2 of the Cochrane RoB tool. Results were presented as network plots, evidence rankings, and league tables. RESULTS: We included 161 RCTs (11 849 participants). Most SMT procedures were equal to clinical guideline interventions and were slightly more effective than other treatments. When comparing inter-SMT procedures, effects were small and not clinically relevant. A general and nonspecific rather than a specific and targeted SMT approach had the highest probability of achieving the largest effects. Results were based on very low- to low-certainty evidence, mainly downgraded owing to large within-study heterogeneity, high RoB, and an absence of direct comparisons. CONCLUSION: There was low-certainty evidence that clinicians could apply SMT according to their preferences and the patients' preferences and comfort. Differences between SMT approaches appear small and likely not clinically relevant. J Orthop Sports Phys Ther 2025;55(2):1-14. Epub 7 January 2025. https://doi.org/10.2519/jospt.2025.12707.
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Dear BF, Staples L, Nielssen O, Titov N. Examining the Effectiveness and Acceptability of Internet-Delivered Psychological Pain Management for Regional and Rural Australians With Chronic Pain. Aust J Rural Health 2025; 33:e70008. [PMID: 39960117 PMCID: PMC11831721 DOI: 10.1111/ajr.70008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2024] [Revised: 01/02/2025] [Accepted: 02/07/2025] [Indexed: 02/20/2025] Open
Abstract
OBJECTIVE To examine the characteristics, satisfaction levels and clinical outcomes of rural and remote Australians with chronic pain completing an internet-delivered psychological pain management program (PMP). DESIGN Longitudinal routine care cohort study. SETTING An Australian national digital psychology service. PARTICIPANTS Patients in inner regional locations (n = 401), outer regional and remote locations (n = 198), and major cities (n = 968), who used the service over a 6-year period. MAIN OUTCOME MEASURES Demographic and clinical data, patient-reported satisfaction and improvements, and meaningful clinical improvements (≥ 30% improvement). RESULTS Clinical improvements were observed from pre-treatment to post-treatment in pain-related disability (32% [95% CI: 29, 34]), depression symptoms (44% [95% CI: 39, 49]), anxiety symptoms (43% [95% CI: 39, 47]), and average pain intensity (23% [95% CI: 21, 26]), which were maintained to 3-month follow-up. High levels of satisfaction and treatment completion were also observed. Minor demographic and clinical differences were observed. However, there were similar rates of clinical improvement, treatment satisfaction and treatment completion in all groups. CONCLUSIONS The current findings further highlight the value of internet-delivered psychological PMPs for Australians with chronic pain living in regional and remote parts of the country. Further work is needed to raise awareness about the availability of these effective programmes and to integrate their use with traditional pain management services.
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Affiliation(s)
- Blake F. Dear
- MindSpot, MQ HealthMacquarie UniversitySydneyAustralia
| | | | - Olav Nielssen
- MindSpot, MQ HealthMacquarie UniversitySydneyAustralia
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Thompson R, Fors M, Kammerlind AS, Tingström P, Abbott A, Johansson K. The PainSMART project: Protocol for a research program on effectiveness, mechanisms of effect and patient-practitioner experiences of the PainSMART-strategy as an adjunct to usual primary care physiotherapy management for musculoskeletal pain. PLoS One 2025; 20:e0316806. [PMID: 39883724 PMCID: PMC11781673 DOI: 10.1371/journal.pone.0316806] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2024] [Accepted: 12/13/2024] [Indexed: 02/01/2025] Open
Abstract
BACKGROUND Musculoskeletal pain (MSKP) disorders entail a significant burden for individuals and healthcare systems. The PainSMART-strategy has been developed aiming to reduce divergences between patients and healthcare practitioners in their understanding of MSKP by providing a shared basis for communication and to facilitate patients' self-management of MSKP. The objective of the PainSMART-project is to evaluate the effects of the PainSMART-strategy as an adjunct to usual physiotherapy management compared to usual physiotherapy management alone. METHODS The PainSMART-project is a research program with a collective suite of studies utilising mixed methods, centred around a randomised controlled trial (ClinicalTrials.gov NCT06187428). Subjects: Adults (18 years or older) seeking primary care for MSKP who are triaged and booked for an initial physiotherapy consultation at five primary care physiotherapy departments within the Swedish public healthcare regions of Östergötland and Jönköping. A total of 490 subjects will be randomised to receive one of two possible interventions. INTERVENTIONS Both groups will receive usual physiotherapy management for benign MSKP. The intervention group will also receive the PainSMART-strategy consisting of an educational film, reflection and reinforcement of the film's key messages prior to the initial physiotherapy consultation and a patient-practitioner discussion based on the film. OUTCOME The primary outcome is 1) between group mean change over time from baseline to 24 hours post initial physiotherapy consultation and baseline to 3 months regarding self-reported average pain intensity and pain self-efficacy. Secondary outcomes include similar measurements for MSKP illness perception, reassurance of benign nature, pain coping, physical activity, analgesic medication use, sick leave, healthcare use and direct healthcare costs. Physiotherapist and patient reported experience measures and qualitative evaluation of the effects of the PainSMART-strategy on communication at the initial physiotherapy consultation will also be explored. DISCUSSION This study will investigate potential added effects of PainSMART-strategy upon usual primary care physiotherapy for MSKP.
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Affiliation(s)
- Richard Thompson
- Unit of Physiotherapy, Division of Prevention, Rehabilitation and Community Medicine, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
- Rehab Finspång, Region Östergötland, Finspång, Sweden
| | - Maria Fors
- Unit of Physiotherapy, Division of Prevention, Rehabilitation and Community Medicine, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
- Department of Activity and Health and Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
| | - Ann-Sofi Kammerlind
- Unit of Physiotherapy, Division of Prevention, Rehabilitation and Community Medicine, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
- Futurum, Region Jönköping County, Jönköping, Sweden
| | - Pia Tingström
- Division of Nursing Sciences and Reproductive Health, Department of Medical and Health Sciences, Linkoping University, Linkoping, Sweden
| | - Allan Abbott
- Unit of Physiotherapy, Division of Prevention, Rehabilitation and Community Medicine, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
- Department of Orthopaedics, Linköping University Hospital, Linköping, Sweden
| | - Kajsa Johansson
- Unit of Physiotherapy, Division of Prevention, Rehabilitation and Community Medicine, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
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Vicente-Mampel J, Hernández-Zaballos F, Falaguera-Vera FJ, Sánchez-Poveda D, Jaenada-Carrilero E, Huertas-Ramírez B, Sánchez-Montero FJ. Catastrophizing as a Predictor for Pain Perception and Disability Among Patients Undergoing Spinal Cord Stimulation. MEDICINA (KAUNAS, LITHUANIA) 2025; 61:141. [PMID: 39859123 PMCID: PMC11766538 DOI: 10.3390/medicina61010141] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/03/2024] [Revised: 01/11/2025] [Accepted: 01/13/2025] [Indexed: 01/27/2025]
Abstract
Background and Objectives: The International Society for Modulation defines persistent spinal pain syndrome type 2 (PSPS-type 2), formerly known as failed back surgery syndrome, as a condition where patients continue to experience pain or develop new pain following spinal surgery intended to alleviate back or lower-limb discomfort. PSPS-type 2 is characterized by pain and significant disability, affecting quality of life. Spinal cord stimulation has proven effective in treating this syndrome, although the role of psychological factors, such as pain catastrophizing and central sensitization, remain unclear. This study seeks to examine the potential connection between psychosocial responses and both functionality and pain perception in patients with persistent spinal pain syndrome type 2 who have undergone spinal cord stimulation treatment. Materials and Methods: A single-site, cross-sectional study was conducted on individuals diagnosed with persistent spinal pain syndrome type 2 who were receiving spinal cord stimulation. Study participants were required to meet specific eligibility criteria and were assessed for disability, pain perception, fear of movement, pain catastrophizing, and central sensitization. The spinal cord stimulation procedure involved the placement of electrodes at vertebral levels T8-T11 for precise pain control, with a particular focus on targeting the dorsal root ganglion to alleviate chronic pain. Results: Thirty-seven patients with persistent spinal pain syndrome type 2 have undergone spinal cord stimulation treatment for 4.68 ± 5.25 years. Clinical assessments indicated a pain perception score of 5.6 ± 1.96, Central Sensitization Inventory score of 42.08 ± 18.39, disability score of 37.62 ± 16.13, fear of movement score of 33.11 ± 8.76, and pain catastrophizing score of 28.43 ± 13.14. Finally, pain catastrophizing was significantly associated with pain perception (β = 0.075 and p = 0.008) and disability (β = 0.90 and p < 0.01). Conclusions: Catastrophizing plays a crucial role in pain perception and disability among patients with persistent spinal pain syndrome type 2 receiving spinal cord stimulation. Integrating psychological interventions may improve clinical outcomes for these patients.
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Affiliation(s)
- Juan Vicente-Mampel
- Medicine and Health Science School, Department of Physiotherapy, Catholic University of Valencia, 46001 Torrent, Spain; (J.V.-M.); (F.J.F.-V.); (B.H.-R.)
| | - Felipe Hernández-Zaballos
- Anaesthesiology Service, Pain Unit, Complejo Asistencial Universitario de Salamanca (CAUSA), 37007 Salamanca, Spain; (F.H.-Z.); (D.S.-P.); (F.J.S.-M.)
| | - Francisco Javier Falaguera-Vera
- Medicine and Health Science School, Department of Physiotherapy, Catholic University of Valencia, 46001 Torrent, Spain; (J.V.-M.); (F.J.F.-V.); (B.H.-R.)
| | - David Sánchez-Poveda
- Anaesthesiology Service, Pain Unit, Complejo Asistencial Universitario de Salamanca (CAUSA), 37007 Salamanca, Spain; (F.H.-Z.); (D.S.-P.); (F.J.S.-M.)
| | - Eloy Jaenada-Carrilero
- Medicine and Health Science School, Department of Physiotherapy, Catholic University of Valencia, 46001 Torrent, Spain; (J.V.-M.); (F.J.F.-V.); (B.H.-R.)
| | - Borja Huertas-Ramírez
- Medicine and Health Science School, Department of Physiotherapy, Catholic University of Valencia, 46001 Torrent, Spain; (J.V.-M.); (F.J.F.-V.); (B.H.-R.)
| | - Francisco Jose Sánchez-Montero
- Anaesthesiology Service, Pain Unit, Complejo Asistencial Universitario de Salamanca (CAUSA), 37007 Salamanca, Spain; (F.H.-Z.); (D.S.-P.); (F.J.S.-M.)
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Suri P, Korpak A, Timmons A, Tanus AD, Brubeck H, Costa N, Staab CA, Hodges P, Daniels CJ, Heagerty PJ, Jensen MP. Convergent validity of a person-dependent definition of a low back pain flare. MEDRXIV : THE PREPRINT SERVER FOR HEALTH SCIENCES 2025:2025.01.11.25320390. [PMID: 39867371 PMCID: PMC11759251 DOI: 10.1101/2025.01.11.25320390] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 01/28/2025]
Abstract
Exacerbations of existing low back pain (LBP) or new LBP episodes are colloquially referred to as "flares". Although the experience of flares is common to many people with LBP, few validated measures enable people to self-report if they are experiencing a flare. This study examined the convergent validity of a person-dependent definition of flares ("a worsening of your low back pain that lasts from hours to weeks") as compared to (1) LBP intensity, (2) LBP-related pain interference, and (3) analgesic use, in a large, prospective research study of Veterans with LBP. Veterans seeking care for LBP (n=465) were followed prospectively for up to 1 year. Participants completed up to 36 scheduled surveys and additional patient-initiated surveys (triggered by the onset of new flares) over follow-up. Each survey inquired about current flare status, pain intensity measured on a 0 to 10 numeric rating scale (NRS), LBP-related pain interference, and analgesic use. Linear mixed-effects models estimated the association between current flare status and pain intensity, with and without adjustment for potential confounding factors; secondary analyses examined associations with pain interference and analgesic use. In longitudinal analyses of 11,817 surveys, flare status was significantly associated with a 2.8-NRS-point greater pain intensity (p<0.0001), with and without adjustment for other factors. Statistically significant associations were found between flare status and LBP-related pain interference and analgesic use. New flare periods were associated with impacts on coping, functional limitations, and mood/emotions. These findings support the convergent validity of a person-dependent flare definition.
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Affiliation(s)
- Pradeep Suri
- Rehabilitation Care Services, VA Puget Sound Health Care System, USA
- Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, USA
- Clinical Learning, Evidence, and Research (CLEAR) Center, University of Washington, Seattle, USA
- Department of Rehabilitation Medicine, University of Washington, Seattle, USA
| | - Anna Korpak
- Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, USA
| | - Andrew Timmons
- Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, USA
| | - Adrienne D. Tanus
- Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, USA
| | - Hannah Brubeck
- Seattle Epidemiologic Research and Information Center, VA Puget Sound Health Care System, Seattle, USA
| | - Nathalia Costa
- The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Australia
- The University of Queensland, University of Queensland’s Clinical Trials Capability Team (ULTRA), Brisbane, Australia
| | - Carina A. Staab
- Department of Child, Family, and Population Health Nursing, University of Washington, Seattle, USA
| | - Paul Hodges
- The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Australia
| | - Clinton J. Daniels
- Rehabilitation Care Services, VA Puget Sound Health Care System, USA
- Department of Rehabilitation Medicine, University of Washington, Seattle, USA
| | - Patrick J. Heagerty
- Clinical Learning, Evidence, and Research (CLEAR) Center, University of Washington, Seattle, USA
- Department of Biostatistics, University of Washington, Seattle, USA
| | - Mark P. Jensen
- Department of Rehabilitation Medicine, University of Washington, Seattle, USA
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Kragting M, Voogt L, Pool-Goudzwaard AL, Twisk JWR, Coppieters MW. The effectiveness of psychologically-informed physiotherapy for people with neck pain and the mediating role of illness perceptions: a replicated single-case experimental design study. Disabil Rehabil 2025:1-14. [PMID: 39792464 DOI: 10.1080/09638288.2024.2442076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2024] [Revised: 12/09/2024] [Accepted: 12/10/2024] [Indexed: 01/12/2025]
Abstract
PURPOSE (1) To evaluate the effectiveness of personalised psychologically-informed physiotherapy in people with neck pain; (2) To explore the mediating role of changes in illness perceptions. METHOD In this replicated single-case study, 14 patients with non-specific neck pain at risk for chronicity received a personalised intervention addressing unhelpful illness perceptions and dysfunctional movement behaviour, according to principles of cognitive functional therapy. Outcomes included the mediating role of illness perceptions on overall effect, function, pain intensity and self-efficacy. Linear mixed models were used to analyse the data. RESULTS Repeated measurements (14-20 per patient), including a 3-months follow-up, showed a gradual improvement during and/or after psychologically-informed physiotherapy for overall effect, function, pain and to a lesser extent self-efficacy. Changes in each of the illness perception dimensions showed a mediation effect on overall effect, function and pain. When combining the dimensions "consequences," "personal control," "identity," "concern" and "emotional response," changes in illness perceptions explained approximately 35% of the improvement in overall effect. CONCLUSION Addressing unhelpful illness perceptions appears valuable in the management of patients with chronic or recurrent non-specific neck pain. Intervention effects extended beyond the treatment period, indicating that patients' improved understanding of their health condition continued to have a positive impact.
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Affiliation(s)
- Maaike Kragting
- Department of Physical Therapy, Research Centre for Health Care Innovations, Rotterdam University of Applied Sciences, Rotterdam, The Netherlands
- Amsterdam Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Lennard Voogt
- Department of Physical Therapy, Research Centre for Health Care Innovations, Rotterdam University of Applied Sciences, Rotterdam, The Netherlands
- Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium
| | - Annelies L Pool-Goudzwaard
- Amsterdam Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
- Somt University of Physiotherapy, Amersfoort, The Netherlands
| | - Jos W R Twisk
- Department of Epidemiology and Data Science, VU University Medical Center, Amsterdam, The Netherlands
| | - Michel W Coppieters
- Amsterdam Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
- School of Health Sciences and Social Work, Griffith University, Nathan, Brisbane, QLD, Australia
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Maiers MJ, Albertson AK, Major C, Mendenhall H, Petrie CP. The association between individual radiographic findings and improvement after chiropractic spinal manipulation and home exercise among older adults with back-related disability: a secondary analysis. Chiropr Man Therap 2025; 33:2. [PMID: 39773270 PMCID: PMC11708132 DOI: 10.1186/s12998-024-00566-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2024] [Accepted: 12/18/2024] [Indexed: 01/11/2025] Open
Abstract
BACKGROUND Some chiropractors use spinal x-rays to inform care, but the relationship between radiographic findings and outcomes is unclear. This study examined the association between radiographic findings and 30% improvement in back-related disability in older adults after receiving 12 weeks of chiropractic spinal manipulation and home exercise instruction. METHODS This IRB-approved secondary analysis used randomized trial data of community-dwelling adults age ≥ 65 with chronic spinal pain and disability. Data were collected during the parent trial between January 2010-December 2014. The primary outcome of the parent study was ≥ 30% improvement in Oswestry Disability Index (ODI) at 12 weeks, a clinically important response to care. In this secondary analysis, two chiropractic radiologists independently assessed digital lumbar radiographs for pre-specified anatomic, degenerative, and alignment factors; differences were adjudicated. The unadjusted association between baseline radiographic factors and 30% ODI improvement was determined using chi-square tests. RESULTS From the parent trial, 120 adults with baseline lumbar radiographs were included in this study. Mean age was 70.4 years (range 65-81); 59.2% were female. Mean baseline disability (ODI = 25.6) and back pain (5.2, 0-10 scale) were moderate. Disc degeneration (53.3% moderate, 13.3% severe), anterolisthesis (53.3%), retrolisthesis (36.6%) and scoliosis (35.0%) were common among the participant sample. After 12-weeks of treatment, 51 (42.5%) participants achieved 30% improvement in back disability. No alignment, degenerative, or anatomic factors were associated with ODI improvement at 12 weeks (all p > 0.05), regardless of severity of radiographic findings. CONCLUSION We found no association between a predetermined subset of radiographic findings and improvement in back-related disability among this sample of older adults. As such, this study provides preliminary data suggesting that imaging may be unhelpful for predicting response to chiropractic spinal manipulation and home exercise.
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Affiliation(s)
- Michele J Maiers
- Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN, 55431, USA.
- RAND Research Across Complementary and Integrative Health Institutions (REACH) Center, 1776 Main Street, Santa Monica, CA, 90401-3208, USA.
| | - Andrea K Albertson
- Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN, 55431, USA
| | - Christopher Major
- Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN, 55431, USA
| | - Heidi Mendenhall
- Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN, 55431, USA
| | - Christopher P Petrie
- Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN, 55431, USA
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Jurak I, Grabar S, Žura N, Jakuš L. Evaluating the Efficacy of Capacitive Resistive Monopolar Radiofrequency Combined With Proprioceptive Neuromuscular Facilitation in Managing Chronic Low Back Pain: A Randomised Controlled Trial. PHYSIOTHERAPY RESEARCH INTERNATIONAL 2025; 30:e70009. [PMID: 39572389 PMCID: PMC11582020 DOI: 10.1002/pri.70009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2024] [Revised: 10/25/2024] [Accepted: 11/03/2024] [Indexed: 11/24/2024]
Abstract
BACKGROUND AND PURPOSE This randomised controlled trial evaluates the effectiveness of capacitive resistive monopolar radiofrequency (CRMRF) combined with proprioceptive neuromuscular facilitation (PNF) training in managing chronic low back pain (CLBP). Given the multifactorial nature of CLBP, this study explores a multimodal treatment approach integrating CRMRF, known for its thermal effects and ability to alleviate pain through improved cell metabolism and microcirculation, with PNF training, which enhances muscle strength, flexibility, and proprioception. METHODS This study was designed as a single-blind, parallel, randomised controlled trial conducted in an outpatient clinical setting. Over the course of four months, 62 participants, suffering from chronic low back pain were randomly assigned to receive either the combined CRMRF and PNF treatment or PNF alone, with primary outcomes measured in terms of pain and functional disability using the Visual Analogue Scale (VAS), Oswestry Disability Index (ODI). For secondary outcome of disability associated with pain, Quebec Pain Disability Scale (QPDS) and Roland-Morris Disability Questionnaire (RMDQ) were used. The study's hypothesis was that the combined treatment would reduce pain and disability more effectively than PNF alone. RESULTS Results indicated that the experimental group experienced greater improvements in pain and functional disability, surpassing the minimally clinically important difference (MCID) for the VAS, ODI, QPDS and RMDQ, suggesting the clinical relevance of the combined CRMRF and PNF approach. DISCUSSION These findings are consistent with previous research highlighting the benefits of CRMRF in various musculoskeletal disorders and suggest that integrating CRMRF with PNF training offers a promising non-invasive treatment option for CLBP sufferers. Overall, our study contributes to the growing evidence base supporting innovative, multimodal treatment strategies for managing CLBP, with the potential to enhance patients' quality of life. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT05682287.
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Affiliation(s)
- Ivan Jurak
- Department of PhysiotherapyUniversity of Applied Health SciencesZagrebCroatia
| | - Silvija Grabar
- Department of PhysiotherapyPolyclinic CerebellumVaraždinCroatia
| | - Nikolino Žura
- Department of PhysiotherapyUniversity of Applied Health SciencesZagrebCroatia
- Department of Rheumatology and RehabilitationKBC ZagrebZagrebCroatia
| | - Lukrecija Jakuš
- Department of PhysiotherapyUniversity of Applied Health SciencesZagrebCroatia
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Brintz CE, Connors Kelly E, Polser G, Rhoten BA, Foote Pearce M, Coronado RA, O’Donnell R, Block S, Priest A, Gupta R, Whitaker ST, Bruehl S, Stephens BF, Abtahi AM, Schwarz J, Zuckerman SL, French B, Archer KR. Feasibility, Acceptability and Modification of a Post-surgical Telehealth Mindfulness-Based Intervention to Enhance Recovery After Lumbar Spine Surgery: A Prospective Intervention Study. GLOBAL ADVANCES IN INTEGRATIVE MEDICINE AND HEALTH 2025; 14:27536130251344843. [PMID: 40417705 PMCID: PMC12099095 DOI: 10.1177/27536130251344843] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/09/2024] [Revised: 04/23/2025] [Accepted: 05/08/2025] [Indexed: 05/27/2025]
Abstract
Background People who undergo lumbar spine surgery experience variable pain, disability, and quality of life outcomes. Mindfulness-based interventions (MBIs) are recommended for chronic low back pain and may be an effective approach for surgical patients. Objectives Evaluate the feasibility and acceptability of a telehealth MBI following lumbar spine surgery and refine the intervention for optimal delivery. Methods This was a prospective, mixed-methods, single-arm cohort study with measurements preoperatively and 2 weeks and 3 months postoperatively. Participants were adults undergoing lumbar spine surgery for a degenerative condition at an academic medical center. A telehealth MBI was delivered one-on-one within 4 weeks after surgery and consisted of 8 weekly sessions modeled after Mindfulness-Based Cognitive Therapy for Chronic Pain. Outcomes were feasibility (enrollment rate, retention, session attendance, homework completion), acceptability (intervention satisfaction questionnaire and exit interview); and pre- to 3-month postoperative improvements in patient-reported disability, pain, and psychosocial factors including depression, anxiety, pain catastrophizing, kinesiophobia, self-efficacy, perceived stress, and dispositional mindfulness. Results Fifteen participants who received a laminectomy (n = 3) or fusion with (n = 9)/without (n = 3) laminectomy initiated the MBI. Enrollment (35%) and retention (80%) rates were lower than hypothesized, but participants had high levels of session attendance (80% completed) and home practice (median = 95% days assigned). The MBI was perceived as highly acceptable on the satisfaction questionnaire and exit interviews. Most participants reported improvements at or above established minimal clinically important differences for disability and pain at 3 months postoperatively and improvements in most psychosocial factors. Themes from exit interviews informed future modifications to the intervention. Conclusions Delivery of an 8-session, one-on-one, telehealth MBI to patients after lumbar spine surgery is feasible and acceptable and patients perceive meaningful benefits to their surgical recovery from the MBI. Results support fully powered randomized controlled trials to determine longer-term post-surgical effects of the MBI.
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Affiliation(s)
- Carrie E. Brintz
- Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA
- Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Erin Connors Kelly
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Physical Medicine and Rehabilitation, Vanderbilt UniversityMedical Center, Nashville, TN, USA
| | - Geneva Polser
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Physical Medicine and Rehabilitation, Vanderbilt UniversityMedical Center, Nashville, TN, USA
| | | | - Michelle Foote Pearce
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Physical Medicine and Rehabilitation, Vanderbilt UniversityMedical Center, Nashville, TN, USA
| | - Rogelio A. Coronado
- Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Physical Medicine and Rehabilitation, Vanderbilt UniversityMedical Center, Nashville, TN, USA
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Roisin O’Donnell
- Department of Psychiatry, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Shannon Block
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Amanda Priest
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Rishabh Gupta
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Sarah T. Whitaker
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Stephen Bruehl
- Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA
- Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Byron F. Stephens
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Amir M. Abtahi
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Jacob Schwarz
- Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Scott L. Zuckerman
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Benjamin French
- Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Kristin R. Archer
- Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA
- Osher Center for Integrative Health, Vanderbilt University Medical Center, Nashville, TN, USA
- Department of Physical Medicine and Rehabilitation, Vanderbilt UniversityMedical Center, Nashville, TN, USA
- Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN, USA
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Seyedhoseinpoor T, Sanjari MA, Taghipour M, Dadgoo M, Mousavi SJ. Spinopelvic malalignment correlates to lumbar instability and lumbar musculature in chronic low back pain-an exploratory study. Sci Rep 2024; 14:31974. [PMID: 39738674 PMCID: PMC11685714 DOI: 10.1038/s41598-024-83570-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2024] [Accepted: 12/16/2024] [Indexed: 01/02/2025] Open
Abstract
As PI-LL mismatch is an effective index for spinal surgery and PI-LL less than 10 probably indicates better quality of life, this study aimed to assess spinopelvic parameters, lumbar instability, and lumbar muscle morphology in patients with chronic low back pain (CLBP) with different PI-LL mismatches. This cross-sectional study included 158 CLBP patients. The association between lumbar extensor muscle morphology (measured from magnetic resonance imaging) and spinopelvic parameters (measured from standing lateral radiographs) and lumbar instability (measured from lumbar flexion/extension radiographs) was compared between two groups of patients with different PI-LL mismatch. PI-LL mismatch showed a significant medium association with lumbar spine stability (χ2 = 8.06, p-value = 0.005, OR = 0.26, 95% CI = 0.10 to 0.69). Total cross-sectional area (TCSA) (OR = < 0.001, 95% CI = < 0.001 to < 0.001), functional cross-sectional area (FCSA) (OR = < 0.001, 95% CI = < 0.001 to < 0. 001) of the multifidus, psoas major TCSA (OR = < 0.001, 95% CI = < 0.001 to < 0.001) and its FCSA (OR = < 0.001, 95% CI = < 0.001 to 0.009) showed a strong negative association with PI-LL mismatch. Patients with lower PI-LL mismatch are younger and have less spinopelvic deviation. They have more local spinal compensatory mechanisms such as increased lumbar lordosis. They have better lumbar musculature and less disability but more lumbar instability.
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Affiliation(s)
- Tahere Seyedhoseinpoor
- Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Islamic Republic of Iran
| | - Mohammad Ali Sanjari
- Biomechanics Lab, Rehabilitation Research Center and Department of Basic Rehabilitation Sciences, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 1545913487, Islamic Republic of Iran.
| | - Mohammad Taghipour
- Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Islamic Republic of Iran
| | - Mehdi Dadgoo
- Rehabilitation Research Center, Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Islamic Republic of Iran
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Copley S, Batterham A, Shah A, Foly A, Hagedorn JM, Deer T, Gilligan C, Eldabe S. Systematic Review and Meta-analysis of Stimulation of the Medial Branch of the Lumbar Dorsal Rami for the Treatment of Chronic Low Back Pain. Neuromodulation 2024; 27:1285-1293. [PMID: 39320283 DOI: 10.1016/j.neurom.2024.08.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2024] [Revised: 07/30/2024] [Accepted: 08/05/2024] [Indexed: 09/26/2024]
Abstract
INTRODUCTION Chronic low back pain (CLBP) is often associated with impaired motor control and degeneration of the lumbar multifidus muscles. Several studies have reported on the utility of multifidus or medial branch stimulation as a treatment. We present a systematic review and meta-analysis of studies reporting on the change in low back pain intensity with multifidus stimulation. MATERIALS AND METHODS A comprehensive literature search was conducted from 2010 to 2022 for randomized controlled trials or prospective reports in adults with CLBP, treated with multifidus or medial nerve stimulation through implanted or percutaneous device. Mean change (standard error) in pain intensity was extracted and data synthesized using a mixed effects regression with a random intercept for the study to account for repeated time points. RESULTS A total of 419 participants were enrolled in six studies; there were 25 effects (one to six time points per study), with follow-ups ranging from 1.5 to 48 months. The weighted pooled mean effect was a reduction in pain intensity (0-10 scale) of 2.9 units (95% CI: 2.1-3.7). The 95% prediction interval was a reduction in pain intensity of 0.6 to 5.2 units. The estimated probability of a reduction in pain of >two units in a new similar study is 0.84 (0.68-0.98). Meta-regression revealed that a longer follow-up time was associated with greater reductions in pain (0.25 units [0.16-0.34] per six months). CONCLUSIONS Medial branch stimulation for the treatment of CLBP shows a high probability of a clinically significant change in pain intensity. Longer duration of stimulation was associated with decreased low back pain intensities.
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Affiliation(s)
- Sue Copley
- Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.
| | - Alan Batterham
- Professor Emeritus, School of Health and Life Sciences, Teesside University, Middlesbrough, UK
| | - Anuj Shah
- Weill Cornell Tri-Institute, New York, NY, USA
| | - Ahmed Foly
- Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK
| | | | - Timothy Deer
- The Spine and Nerve Center of the Virginias, Charleston, WV, USA
| | - Chris Gilligan
- Office of the Chief Medical Officer, Robert Wood Johnson University Hospital, New Brunswick, NJ, USA
| | - Sam Eldabe
- Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK
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Yang Y, McCluskey S, Bydon M, Singh JR, Sheeler RD, Nathani KR, Krieger AC, Mehta ND, Weaver J, Jia L, DeCelle S, Schlagal RC, Ayar J, Abduljawad S, Stovitz SD, Ganesh R, Verkuilen J, Knapp KA, Yang L, Härtl R. A Tai chi and qigong mind-body program for low back pain: A virtually delivered randomized control trial. NORTH AMERICAN SPINE SOCIETY JOURNAL 2024; 20:100557. [PMID: 39469294 PMCID: PMC11513803 DOI: 10.1016/j.xnsj.2024.100557] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 07/23/2024] [Revised: 08/26/2024] [Accepted: 09/05/2024] [Indexed: 10/30/2024]
Abstract
Background Mind-body treatments have the potential to manage pain, yet their effectiveness when delivered online for the treatment of low back pain (LBP) is unknown. We sought to evaluate whether a virtually delivered mind-body program integrating tai chi, qigong, and meditation (VDTQM) is effective for treating LBP. Methods This randomized controlled trial compared VDTQM (n=175) to waitlist control (n=175). Eligible participants were at least 18 years old, had LBP for at least 6 weeks, were not pregnant, had not previously taken tai chi classes, and had not undergone spine surgery within 6 months. The treatment group received a 12-week VDTQM program in live online 60-minute twice-weekly group classes from September 2022 to December 2022. All participants continued their usual activities and care. Primary outcome was pain-related disability assessed by the Oswestry Disability Index (ODI) score. Secondary outcomes included pain intensity, sleep quality, and quality of life (QOL). Intent-to-treat analyses were conducted. Results Of the 350 participants 278 (79%) were female, mean age was 58.8 years (range: 21-92), 244 (69.7%) completed the 8-week survey, 248 (70.9%) the 12-week, and 238 (68%) the 16 -week. No participants withdrew due to adverse treatment effects. Compared with control group, treatment group experienced statistically and clinically significant improvement in ODI score by -4.7 (95% CI: -6.24 to -3.16, p<.01), -6.42 (95% CI: -7.96 to -4.88, p<.01), and -8.14 (95% CI: -9.68 to -6.59, p<.01) points at weeks 8, 12, and 16, respectively. Treatment group also experienced statistically significant improvement at all time points in the other outcomes. Conclusions Among adults with LBP, VDTQM treatment resulted in small to moderate improvements in pain-related disability, pain intensity, sleep quality, and QOL. Improvements persisted 1 month after treatment concluded. These findings suggest VDTQM may be a viable treatment option for patients with LBP.Trial registration: clincaltrials.gov Identifier: NCT05801588.
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Affiliation(s)
- Yang Yang
- Center for Taiji and Qigong Studies, 151 E 81st St 7D, New York, NY 10028, United States
| | - Sydne McCluskey
- Educational Psychology Program, CUNY Graduate Center, 365 Fifth Av, New York, NY 10016, United States
| | - Mohamad Bydon
- Department of Neurological Surgery, Neuro-Informatics Laboratory, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, United States
| | - Jaspal Ricky Singh
- Department of Rehabilitation Medicine, Weill Cornell Medicine, 525 E. 68th St, New York, NY 10065, United States
| | - Robert D. Sheeler
- Department of Family Medicine, Mayo Clinic, College of Medicine, Rochester, Minnesota, Next Level Concierge Care, 10250 N 92nd St Suite 210, Scottsdale, AZ 85258, United States
| | - Karim Rizwan Nathani
- Department of Neurological Surgery, Neuro-Informatics Laboratory, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, United States
| | - Ana C. Krieger
- Weill Cornell Center for Sleep Medicine, Department of Medicine, Weill Cornell Medical College, 425 East 61st St - 5th floor, New York, NY 10065, United States
| | - Neel D. Mehta
- Department of Anesthesiology, Division of Pain Management, Och Spine at Weill Cornell Medicine/NewYork-Presbyterian Hospital, 240 East 59th St, 2nd Floor, New York, NY 10022, United States
| | - Joshua Weaver
- Department of Neurology, Weill Cornell Medicine, 1305 York Ave, Floor 2, New York, NY 10021, United States
| | - Libin Jia
- Office of Cancer Complementary and Alternative Medicine, Division of Cancer Treatment and Diagnosis, National Cancer Institute, 9609 Medical Center Dr. 1W704, Rockville, MD 20850, United States
| | - Sharon DeCelle
- Private Practice, 309 E Holmes St, Urbana, IL 61801, United States
| | - Robert C. Schlagal
- Department of Reading Education and Special Education, Appalachian State University, Boone, North Carolina, 4717 Valero Ct, Laredo, TX 78046, United States
| | - Jay Ayar
- Department of Public Health, School of Health Sciences and Practice, New York Medical College, 40 Sunshine Cottage Road, Valhalla, NY 10595, United States
| | - Sahar Abduljawad
- Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, Minnesota, Mill City Clinic, 901 South 2nd St, Minneapolis, MN 55415, United States
| | - Steven D. Stovitz
- Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, Minnesota, Mill City Clinic, 901 South 2nd St, Minneapolis, MN 55415, United States
| | - Ravindra Ganesh
- Division of General Internal Medicine, Mayo Clinic College of Medicine, 200 1st St SW, Rochester, MN 55905, United States
| | - Jay Verkuilen
- Educational Psychology Program, CUNY Graduate Center, 365 Fifth Ave, New York, NY 10016, United States
| | - Kenneth A. Knapp
- Department of Public Health, School of Health Sciences and Practice, New York Medical College, 40 Sunshine Cottage Road, Valhalla, NY 10595, United States
| | - Lin Yang
- Department of Cancer Epidemiology and Prevention Research, Cancer Care Alberta, Alberta Health Services, Calgary, Alberta, Canada; Departments of Oncology and Community Health Sciences, Cumming School of Medicine, University of Calgary, 5th Floor, Holy Cross Centre, Box ACB, 2210 - 2 St. SW, Calgary AB T2S 3C3, Canada
| | - Roger Härtl
- Department of Neurological Surgery, Division of Spine Surgery, Och Spine at Weill Cornell Medicine/NewYork-Presbyterian Hospital, 525 East 68th St, Box 99, New York, NY 10065, United States
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Fanuscu A, Öz M, Özel Asliyüce Y, Turhan E, Ülger Ö. Effects of Clinic-based and Telerehabilitation-based Motor Control Exercises in Individuals with Chronic Low-back Pain: A Randomized Controlled Trial With 3-Month Follow-up. Clin J Pain 2024; 40:700-708. [PMID: 39285790 DOI: 10.1097/ajp.0000000000001245] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2024] [Accepted: 09/06/2024] [Indexed: 11/09/2024]
Abstract
OBJECTIVE To evaluate the effectiveness of clinic-based and telerehabilitation-based motor control exercises in individuals with chronic low-back pain 3 months posttreatment. METHODS Forty-two participants were randomized to either clinic-based or telerehabilitation-based groups, performing exercises 3 times weekly for 8 weeks. Assessments were conducted pre-intervention, postintervention and 1 and 3 month follow-ups. The primary outcome was pain intensity (Visual Analog Scale) for low-back pain. RESULTS Both exercise approaches were found to be similarly effective in improving pain disability, quality of life (except for emotional response, energy level, sleep, and social isolation), and pain catastrophizing at both follow-up time points. The Visual Analog Scale showed statistically significant reductions in pain from baseline at all time points in both groups ( P <0.001), with effect sizes ranging from moderate to strong. Nottingham Health Profile showed significant improvements in physical activity, pain, and total score, with effect sizes ranging from moderate to strong. No statistically significant changes in spatiotemporal gait parameters were observed in either group. According to the postintervention intention-to-treat analysis, lumbar flexion range of motion showed statistically significant improvements in both groups with small effect sizes ( P <0.05). DISCUSSION Telerehabilitation-based motor control exercises proved as effective as clinic-based methods in treating chronic low-back pain, offering a viable alternative tailored to individual needs and circumstances.
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Affiliation(s)
- Aybüke Fanuscu
- Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara
| | - Müzeyyen Öz
- Faculty of Health Science, Department of Physical Therapy and Rehabilitation, Çankiri Karatekin University, Çankiri
| | | | - Egemen Turhan
- Department of Orthopedics and Traumatology, Faculty of Medicine, Hacettepe University, Ankara, Turkey
| | - Özlem Ülger
- Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara
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Trager RJ, Baumann AN, Rogers H, Tidd J, Orellana K, Preston G, Baldwin K. Efficacy of manual therapy for sacroiliac joint pain syndrome: a systematic review and meta-analysis of randomized controlled trials. J Man Manip Ther 2024; 32:561-572. [PMID: 38353102 PMCID: PMC11578406 DOI: 10.1080/10669817.2024.2316420] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2023] [Accepted: 01/23/2024] [Indexed: 02/29/2024] Open
Abstract
INTRODUCTION This study examined the efficacy of manual therapy for pain and disability measures in adults with sacroiliac joint pain syndrome (SIJPS). METHODS We searched six databases, including gray literature, on 24 October 2023, for randomized controlled trials (RCTs) examining sacroiliac joint (SIJ) manual therapy outcomes via pain or disability in adults with SIJPS. We evaluated quality via the Physiotherapy Evidence Database scale and certainty via Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Standardized mean differences (SMDs) in post-treatment pain and disability scores were pooled using random-effects models in meta-regressions. RESULTS We included 16 RCTs (421 adults; mean age = 37.7 years), with 11 RCTs being meta-analyzed. Compared to non-manual physiotherapy (i.e. exercise ± passive modalities; 10 RCTs) or sham (1 RCT) interventions, SIJ manual therapy did not significantly reduce pain (SMD: -0.88; 95%-CI: -1.84; 0.08, p = 0.0686) yet had a statistically significant moderate effect in reducing disability (SMD: -0.67; 95% CI: -1.32; -0.03, p = 0.0418). The superiority of individual manual therapies was unclear due to low sample size, wide confidence intervals for effect estimates, and inability to meta-analyze five RCTs with a unique head-to-head design. RCTs were of 'good' (56%) or 'fair' (44%) quality, and heterogeneity was high. Certainty was very low for pain and low for disability outcomes. CONCLUSION SIJ manual therapy appears efficacious for improving disability in adults with SIJPS, while its efficacy for pain is uncertain. It is unclear which specific manual therapy techniques may be more efficacious. These findings should be interpreted cautiously until further high-quality RCTs are available examining manual therapy against control groups such as exercise. REGISTRATION PROSPERO (CRD42023394326).
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Affiliation(s)
- Robert J. Trager
- Connor Whole Health, University Hospitals Cleveland Medical Center, Cleveland, OH, USA
- Department of Family Medicine and Community Health, School of Medicine, Case Western Reserve University, Cleveland, OH, USA
- Department of Biostatistics and Bioinformatics Clinical Research Training Program, Duke University School of Medicine, Durham, NC, USA
| | - Anthony N. Baumann
- College of Medicine, Northeast Ohio Medical University, Rootstown, OH, USA
- Department of Rehabilitation Services, University Hospitals, Cleveland, OH, USA
| | - Hudson Rogers
- College of Medicine, Northeast Ohio Medical University, Rootstown, OH, USA
| | - Joshua Tidd
- College of Medicine, Northeast Ohio Medical University, Rootstown, OH, USA
| | - Kevin Orellana
- Department of Orthopedic Surgery, Children’s Hospital of Philadelphia, Philadelphia, OH, USA
| | - Gordon Preston
- Department of Orthopedic Surgery, Cleveland Clinic Akron General, Akron, OH, USA
| | - Keith Baldwin
- Department of Orthopedic Surgery, Children’s Hospital of Philadelphia, Philadelphia, OH, USA
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Farrell S, Smith A, Schneider B, Schneider G, Grondin D, Gelley G, Bobos P, Maher CG, Gross AR. Glucocorticoid facet joint injection for chronic back or neck pain. Cochrane Database Syst Rev 2024; 11:CD015354. [PMID: 39569679 PMCID: PMC11580111 DOI: 10.1002/14651858.cd015354] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/22/2024]
Abstract
OBJECTIVES This is a protocol for a Cochrane Review (intervention). The objectives are as follows: The primary objective is to assess the benefits and harms of glucocorticoid facet joint injections in adults with chronic back or neck pain that is presumed to be facet joint-mediated. The secondary objective is to assess whether the effects differ by diagnostic method for facet joint-mediated pain.
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Affiliation(s)
- Scott Farrell
- RECOVER Injury Research Centre & NHMRC Centre for Research Excellence: Better Health Outcomes for Compensable Injury, The University of Queensland, Brisbane, Australia
| | - Ashley Smith
- Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, Canada
| | - Byron Schneider
- Physical Medicine and Rehabilitation, Vanderbilt University, Tennessee, Kentucky, USA
| | - Geoff Schneider
- Cumming School of Medicine, University of Calgary, Calgary, Canada
| | - Diane Grondin
- Canadian Memorial Chiropractic College, Toronto, Canada
| | - Geoffrey Gelley
- Private Practice, Gelley Chiropractic Clinic, Winnipeg, Canada
| | - Pavlos Bobos
- Faculty of Health Sciences, Department of Health and Rehabilitation Sciences, Western University, London, Canada
| | | | - Anita R Gross
- School of Rehabilitation Science, McMaster University, Hamilton, Canada
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C Areias A, G Moulder R, Molinos M, Janela D, Bento V, Moreira C, Yanamadala V, P Cohen S, Dias Correia F, Costa F. Predicting Pain Response to a Remote Musculoskeletal Care Program for Low Back Pain Management: Development of a Prediction Tool. JMIR Med Inform 2024; 12:e64806. [PMID: 39561359 PMCID: PMC11615557 DOI: 10.2196/64806] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2024] [Revised: 09/05/2024] [Accepted: 10/23/2024] [Indexed: 11/21/2024] Open
Abstract
BACKGROUND Low back pain (LBP) presents with diverse manifestations, necessitating personalized treatment approaches that recognize various phenotypes within the same diagnosis, which could be achieved through precision medicine. Although prediction strategies have been explored, including those employing artificial intelligence (AI), they still lack scalability and real-time capabilities. Digital care programs (DCPs) facilitate seamless data collection through the Internet of Things and cloud storage, creating an ideal environment for developing and implementing an AI predictive tool to assist clinicians in dynamically optimizing treatment. OBJECTIVE This study aims to develop an AI tool that continuously assists physical therapists in predicting an individual's potential for achieving clinically significant pain relief by the end of the program. A secondary aim was to identify predictors of pain nonresponse to guide treatment adjustments. METHODS Data collected actively (eg, demographic and clinical information) and passively in real-time (eg, range of motion, exercise performance, and socioeconomic data from public data sources) from 6125 patients enrolled in a remote digital musculoskeletal intervention program were stored in the cloud. Two machine learning techniques, recurrent neural networks (RNNs) and light gradient boosting machine (LightGBM), continuously analyzed session updates up to session 7 to predict the likelihood of achieving significant pain relief at the program end. Model performance was assessed using the area under the receiver operating characteristic curve (ROC-AUC), precision-recall curves, specificity, and sensitivity. Model explainability was assessed using SHapley Additive exPlanations values. RESULTS At each session, the model provided a prediction about the potential of being a pain responder, with performance improving over time (P<.001). By session 7, the RNN achieved an ROC-AUC of 0.70 (95% CI 0.65-0.71), and the LightGBM achieved an ROC-AUC of 0.71 (95% CI 0.67-0.72). Both models demonstrated high specificity in scenarios prioritizing high precision. The key predictive features were pain-associated domains, exercise performance, motivation, and compliance, informing continuous treatment adjustments to maximize response rates. CONCLUSIONS This study underscores the potential of an AI predictive tool within a DCP to enhance the management of LBP, supporting physical therapists in redirecting care pathways early and throughout the treatment course. This approach is particularly important for addressing the heterogeneous phenotypes observed in LBP. TRIAL REGISTRATION ClinicalTrials.gov NCT04092946; https://clinicaltrials.gov/ct2/show/NCT04092946 and NCT05417685; https://clinicaltrials.gov/ct2/show/NCT05417685.
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Affiliation(s)
| | - Robert G Moulder
- Institute for Cognitive Science, University of Colorado Boulder, Boulder, CO, United States
| | | | | | | | - Carolina Moreira
- Sword Health Inc, Draper, UT, United States
- Instituto de Ciências Biomédicas Abel Salazar, Porto, Portugal
| | - Vijay Yanamadala
- Sword Health Inc, Draper, UT, United States
- Department of Surgery, Quinnipiac University Frank H Netter School of Medicine, Hamden, CT, United States
- Department of Neurosurgery, Hartford Healthcare Medical Group, Westport, CT, United States
| | - Steven P Cohen
- Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States
- Department of Physical Medicine and Rehabilitation, Johns Hopkins School of Medicine, Baltimore, MD, United States
- Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States
- Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD, United States
- Department of Anesthesiology, Uniformed Services University of the Health Sciences, Bethesda, MD, United States
- Department of Physical Medicine and Rehabilitation, Uniformed Services University of the Health Sciences, Bethesda, MD, United States
| | - Fernando Dias Correia
- Sword Health Inc, Draper, UT, United States
- Neurology Department, Centro Hospitalar e Universitário do Porto, Porto, Portugal
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