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Mehraban Jahromi M, Mollaei Z, Vlček P, Grünerová Lippertová M. Effects of botulinum toxin on pain control mechanisms, muscle structure and cortical reorganization, a mini-review. Toxicon 2025; 260:108343. [PMID: 40221105 DOI: 10.1016/j.toxicon.2025.108343] [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: 11/25/2024] [Revised: 04/01/2025] [Accepted: 04/04/2025] [Indexed: 04/14/2025]
Abstract
Spasticity often results in significant disability, which complicates rehabilitation and daily activities. This review explores the role of botulinum toxin type A (BoNT-A) in the treatment of spasticity, focusing on its effects on muscle structure and activity, function, cortical reorganization, and pain. Our findings indicate that BoNT-A injections improve motor function and gait, particularly in stroke patients, by reducing abnormal muscle activity and enhancing postural control. However, BoNT-A may also induce unwanted biomechanical changes, such as muscle atrophy and alterations in contractile elements, which could impact long-term muscle function. Regarding pain management in spasticity, BoNT-A has shown promise by reducing both peripheral and central sensitization mechanisms. Additionally, BoNT-A influences the central nervous system (CNS) by inducing cortical reorganization, which may further contribute to clinical improvements. Lastly, BoNT-A treatment requires careful consideration of individual patient characteristics to optimize outcomes and minimize side effects. A multidisciplinary approach that combines BoNT-A with physical therapy is essential to maximize functional recovery and improve the quality of life in patients with spasticity.
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Affiliation(s)
- Mostafa Mehraban Jahromi
- Department of Physical Therapy, Rehabilitation Science and Athletic Training, University of Kansas Medical Center, Kansas City, United States of America
| | - Zahra Mollaei
- Department of Kinesiology, University of Wisconsin- Milwaukee, Milwaukee, United States of America
| | - Přemysl Vlček
- Third Faculty of Medicine, Charles University, Prague, Czech Republic; National Institute of Mental Health, Klecany, Czech Republic
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O'Connell C, Guo M, Soucy B, Calder M, Sparks J, Plamondon S. All hands on deck: The multidisciplinary rehabilitation assessment and management of hand function in persons with neuromuscular disorders. Muscle Nerve 2025; 71:869-888. [PMID: 38845187 PMCID: PMC11998968 DOI: 10.1002/mus.28167] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2023] [Revised: 04/26/2024] [Accepted: 05/05/2024] [Indexed: 04/16/2025]
Abstract
Hand function is important in every aspect of our lives. Across a wide range of neuromuscular disorders-inherited ataxias, motor neuron diseases, polyneuropathies, and myopathies-people can experience losses in hand strength, tone, movement, dexterity, joint range, and sensation. Such changes can adversely affect function and independence in daily activities, reducing participation and quality of life. People with neuromuscular disorders (pwNMD) known to involve the hand should be assessed at regular intervals for changes both clinically and using impairment, performance, function, and patient-reported outcome measures as appropriate. A patient-centered approach to management is recommended, with clinicians partnering with the individual, their caregivers and the interprofessional teams to create personalized solutions that can overcome barriers to participation and best meet the goals of individuals affected by neuromuscular disorders. Management strategies should be multifaceted, and may include exercise, orthoses, assistive devices, technological solutions, environmental or task adaptations, medications, and/or surgery. Exercise recommendations and orthoses should be individualized and evolve based on disease progression, impairments, and functional limitations. While medications and surgery have a small role for specific clinical situations, there is a plethora of assistive and technological solutions to assist with basic and instrumental activities of daily living, work/education, and leisure for pwNMD with reduced hand function. In addition, clinicians should advocate for appropriate accommodations for reduced hand function at work/school, and the development of and adherence to legislation supporting accessibility and inclusion.
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Affiliation(s)
- Colleen O'Connell
- Stan Cassidy Centre for Rehabilitation, Horizon Health NetworkFrederictonNew BrunswickCanada
- Division of Physical Medicine and RehabilitationDalhousie University Faculty of MedicineHalifaxNova ScotiaCanada
| | - Meiqi Guo
- Toronto Rehabilitation InstituteUniversity Health NetworkTorontoOntarioCanada
- Division of Physical Medicine & Rehabilitation, Faculty of MedicineUniversity of TorontoTorontoOntarioCanada
| | - Béatrice Soucy
- Division of Physical Medicine & Rehabilitation, Department of Clinical Neurosciences, Cumming School of MedicineUniversity of CalgaryCalgaryAlbertaCanada
- Department of Physical Medicine and RehabilitationCentre Hospitalier de l'Université de MontréalMontréalQuébecCanada
| | - Marla Calder
- Stan Cassidy Centre for Rehabilitation, Horizon Health NetworkFrederictonNew BrunswickCanada
| | - Jeff Sparks
- Muscular Dystrophy CanadaSaint JohnNew BrunswickCanada
| | - Stephanie Plamondon
- Division of Physical Medicine & Rehabilitation, Department of Clinical Neurosciences, Cumming School of MedicineUniversity of CalgaryCalgaryAlbertaCanada
- Alberta Health ServicesCalgaryAlbertaCanada
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Cecchella E, Bragazzi NL, Cotellessa F, Campanella W, Puce L, Marinelli L, Currà A, Schenone C, Mori L, Trompetto C. Barriers to Long-Term Adherence in Botulinum Toxin Therapy for Post-Stroke Spasticity: Insights and Implications from a Single-Center Study in North Italy. Toxins (Basel) 2025; 17:102. [PMID: 40137875 PMCID: PMC11946851 DOI: 10.3390/toxins17030102] [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: 01/07/2025] [Revised: 02/09/2025] [Accepted: 02/21/2025] [Indexed: 03/29/2025] Open
Abstract
Stroke is a leading cause of long-term disability worldwide, often resulting in spasticity. Botulinum toxin injections have emerged as a cornerstone in the management of post-stroke spasticity. However, despite their clinical efficacy, maintaining long-term adherence to botulinum toxin therapy remains a significant challenge. This retrospective observational study analyzed 106 patients undergoing botulinum toxin therapy for post-stroke spasticity to identify the key factors influencing treatment continuation. The mean age of the cohort at the time of stroke was 57.7 years, with ischemic strokes accounting for 61.3% of cases and hemorrhagic strokes for 38.7%. A total of 61.3% of patients continued therapy, while 38.7% discontinued therapy due to a variety of reasons. The most common reasons included logistical barriers (43.9%) and comorbidities (36.6%), followed by perceived lack of benefit (24.4%) and clinical resolution (12.2%). Among those citing a lack of benefit, muscular fibrosis was a notable contributor. In the multivariable Cox regression analysis, logistical challenges, such as access to healthcare facilities and administrative difficulties, were associated with discontinuation (HR = 13.95, 95% CI: 5.57-34.94, p < 0.001). Comorbidities also significantly increased the likelihood of discontinuation (HR = 3.51, 95% CI: 1.56-7.87, p = 0.002), as did the lack of benefit (HR = 14.34, 95% CI: 5.65-36.38, p < 0.001) and condition resolution (HR = 19.20, 95% CI: 5.58-66.02, p < 0.001). In contrast, demographic and clinical factors, including age at the time of stroke, gender, stroke type, affected side, and baseline spasticity severity, did not significantly influence treatment continuation. These findings underscore the importance of addressing logistical barriers and mitigating the burden of comorbidities to enhance treatment adherence. A shift toward patient-centered approaches that integrate robust rehabilitation services and streamline healthcare accessibility is critical for optimizing outcomes.
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Affiliation(s)
- Ester Cecchella
- IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy; (E.C.); (W.C.); (L.M.); (L.M.); (C.T.)
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
| | - Nicola Luigi Bragazzi
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
| | - Filippo Cotellessa
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
| | - William Campanella
- IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy; (E.C.); (W.C.); (L.M.); (L.M.); (C.T.)
| | - Luca Puce
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
| | - Lucio Marinelli
- IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy; (E.C.); (W.C.); (L.M.); (L.M.); (C.T.)
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
| | - Antonio Currà
- Academic Neurology Unit, A. Fiorini Hospital, 04019 Terracina, Italy;
- Department of Medico-Surgical Sciences and Biotechnologies, “Sapienza” University of Rome, 00189 Rome, Italy
| | - Cristina Schenone
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
| | - Laura Mori
- IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy; (E.C.); (W.C.); (L.M.); (L.M.); (C.T.)
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
| | - Carlo Trompetto
- IRCCS Ospedale Policlinico San Martino, 16132 Genoa, Italy; (E.C.); (W.C.); (L.M.); (L.M.); (C.T.)
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, 16132 Genoa, Italy; (F.C.); (C.S.)
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Levy J, Karam P, Forestier A, Loze JY, Bensmail D. Botulinum toxin use in patients with post-stroke spasticity: a nationwide retrospective study from France. Front Neurol 2023; 14:1245228. [PMID: 37681005 PMCID: PMC10482253 DOI: 10.3389/fneur.2023.1245228] [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: 06/26/2023] [Accepted: 08/11/2023] [Indexed: 09/09/2023] Open
Abstract
Background Current guidelines recommend intramuscular botulinum toxin type A (BoNT-A) injection as first-line treatment for spasticity, a frequent and impairing feature of various central nervous system (CNS) lesions such as stroke. Patients with spasticity commonly require BoNT-A injections once every 3 to 4 months. We conducted a nationwide, population-based, retrospective cohort study, using the French National Hospital Discharge Database (PMSI), to describe BoNT-A use for spasticity in clinical practice in France between 2014 and 2020. The PMSI database covers the whole French population, corresponding to over 66 million persons. Methods We first searched the PMSI database for healthcare facility discharge of patients who received BoNT-A injections between 2014 and 2020, corresponding to the first set. For each BoNT-A-treated patient, we identified the medical condition for which BoNT-A may have been indicated. Another search of the PMSI database focused on patients admitted for acute stroke between 2014 and 2016 and their spasticity-related care pathway (second set). Overall, two subpopulations were analysed: 138,481 patients who received BoNT-A injections between 2014 and 2020, and 318,025 patients who survived a stroke event between 2014 and 2016 and were followed up until 2020. Results Among the 138,481 BoNT-A-treated patients, 53.5% received only one or two BoNT-A injections. Most of these patients (N = 85,900; 62.0%) received BoNT-A because they had CNS lesions. The number of patients with CNS lesions who received ≥1 BoNT-A injection increased by a mean of 7.5% per year from 2014 to 2019, but decreased by 0.2% between 2019 and 2020, corresponding to the COVID-19 outbreak. In stroke survivors (N = 318,025), 10.7% were coded with post-stroke spasticity, 2.3% received ≥1 BoNT-A injection between 2014 and 2020, and only 0.8% received ≥3 injections within the 12 months following BoNT-A treatment initiation, i.e., once every 3 to 4 months. Conclusion Our analysis of the exhaustive PMSI database showed a suboptimal implementation of BoNT-A treatment recommendations in France. BoNT-A treatment initiation and re-administration are low, particularly in patients with post-stroke spasticity. Further investigations may help explain this observation, and may target specific actions to improve spasticity-related care pathway.
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Affiliation(s)
- Jonathan Levy
- Department of Physical and Rehabilitation Medicine, Raymond-Poincaré Teaching Hospital, AP-HP, Université Paris-Saclay, Garches, France
- Unité INSERM 1179, University of Versailles Saint-Quentin-en-Yvelines, Montigny-Le-Bretonneux, France
| | | | | | | | - Djamel Bensmail
- Department of Physical and Rehabilitation Medicine, Raymond-Poincaré Teaching Hospital, AP-HP, Université Paris-Saclay, Garches, France
- Unité INSERM 1179, University of Versailles Saint-Quentin-en-Yvelines, Montigny-Le-Bretonneux, France
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Alashram AR, Padua E, Aburub A, Raju M, Annino G. Transcranial direct current stimulation for upper extremity spasticity rehabilitation in stroke survivors: A systematic review of randomized controlled trials. PM R 2023; 15:222-234. [PMID: 35286007 DOI: 10.1002/pmrj.12804] [Citation(s) in RCA: 12] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/13/2021] [Revised: 02/24/2022] [Accepted: 02/25/2022] [Indexed: 11/09/2022]
Abstract
OBJECTIVES To examine the effects of transcranial direct current stimulation (tDCS) on upper extremity spasticity after stroke and to define the most effective tDCS parameters. LITERATURE SURVEY Systematic review in the following databases: PubMed, SCOPUS, PEDro, CINAHL, MEDLINE, REHABDATA, AMED, and Web of Science databases. Studies up to June 2020 were included. METHODOLOGY Studies were included if the sample was composed of individuals with stroke, the intervention followed a tDCS intervention (alone or combined with another intervention), and the study was a randomized controlled trial including at least one measurement assessing upper extremity spasticity. Two authors independently screened the included studies. Conflicting decisions between authors were resolved by discussion with the third author. The methodological quality was assessed using the Cochrane Collaboration's tool. The authors determined that the meta-analysis was not feasible due to the heterogeneity in the protocols among the included studies. SYNTHESIS After the screening of 1204 records, a total of seven studies met the specified inclusion criteria and involved 320 participants (mean age = 60.3), 31.1% of whom were females. Patients with ischemic stroke comprised 77.2% of the total patients, and 42.2% were with right hemispheric stroke. Six studies exhibited "high" quality and one exhibited "moderate" quality. Five of the selected studies that combined the tDCS intervention and other traditional interventions showed a significant reduction in upper extremity spasticity after stroke following tDCS intervention. The other two studies that delivered tDCs alone did not show a significant difference. CONCLUSIONS The evidence for the effect of tDCS on upper extremity spasticity after stroke was limited. The optimal tDCS treatment dosage remains unclear. Additional studies with large sample sizes and long-term follow-up are strongly warranted.
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Affiliation(s)
| | - Elvira Padua
- Department of Human Sciences and Promotion of the Quality of Life, San Raffaele Roma Open University, Rome, Italy
| | - Aseel Aburub
- Department of Physiotherapy, Isra University, Amman, Jordan
| | - Manikandan Raju
- Clinical/Experimental Neuroscience and Psychology, Department of Neuroscience Umane, University of Sapienza, Rome, Italy
| | - Giuseppe Annino
- Department of Medicine Systems, University of Rome "Tor Vergata", Rome, Italy
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Denys P, Castaño Botero JC, Vita Nunes RL, Wachs B, Mendes Gomes C, Krivoborodov G, Tu LM, Del-Popolo G, Thompson C, Vilain C, Volteau M, Kennelly M. AbobotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity regardless of spinal cord injury or multiple sclerosis etiology: Pooled analysis of two phase III randomized studies (CONTENT1 and CONTENT2). Neurourol Urodyn 2023; 42:153-167. [PMID: 36321799 PMCID: PMC10092111 DOI: 10.1002/nau.25062] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2022] [Revised: 10/03/2022] [Accepted: 10/09/2022] [Indexed: 11/07/2022]
Abstract
BACKGROUND Neurogenic detrusor overactivity incontinence (NDOI) is often inadequately managed with oral therapy. OBJECTIVE To assess efficacy and safety of abobotulinumtoxinA (aboBoNT-A; Dysport®; Ipsen Ltd.) according to etiology of NDOI. DESIGN, SETTING, AND PARTICIPANTS Two phase III, randomized, double-blind studies (CONTENT1 [NCT02660138] conducted in Asia, Europe and North America; CONTENT2 [NCT02660359] conducted in the Americas, Asia, Europe and Oceania) both included patients with spinal cord injury (SCI) or multiple sclerosis (MS), with inadequately managed NDOI, regularly performing clean intermittent catheterization (CIC). INTERVENTION Patients in CONTENT1 and CONTENT2 received aboBoNT-A injections 600 U (n = 162)/800 U (n = 161), or placebo (n = 162) into the detrusor muscle. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary endpoint: mean change from baseline in number of NDOI episodes/week at Week 6. Secondary endpoints: proportion of patients with no NDOI episodes; incontinence-related quality of life (I-QoL); urodynamic parameters; and time-to-retreatment. Safety was also assessed. Statistical analyses were conducted for pooled populations by etiology (aboBoNT-A doses vs. placebo). RESULTS AND LIMITATIONS Of 485 randomized patients, 341 (70%) and 144 (30%) had SCI and MS etiologies, respectively. A significant reduction was observed in mean NDOI episodes/week at Week 6 with both aboBoNT-A doses versus placebo in the SCI (all p < 0.001) and MS (all p < 0.01) groups, as well as significant improvements in I-QoL and urodynamic parameters. Median time-to-retreatment was longer in patients with MS (48-62 weeks across doses) than those with SCI (39-44 weeks). Safety data were similar between etiologies. Urinary tract infection was the most frequent adverse event; similar numbers were reported across treatment groups. CONCLUSIONS AboBoNT-A was well tolerated and significantly improved continence and bladder function, and QoL, in patients with SCI or MS with NDOI performing regular CIC. PATIENT SUMMARY AboBoNT-A injections improved QoL, symptoms, and bladder function in patients with SCI or MS with bladder muscle overactivity that causes incontinence.
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Affiliation(s)
- Pierre Denys
- Department of Neuro-Urology and Andrology, Raymond-Poincaré Hospital, Assistance Publique-Hôpitaux de Paris, Garches, France
| | | | | | - Barton Wachs
- Chief Urology Section, Atlantic Urology Medical Group, Long Beach, California, USA
| | | | - Grigory Krivoborodov
- Department of Urology, Pirogov Russian National Research Medical University, Moscow, Russia
| | - Le Mai Tu
- Urology Division, Department of Surgery, Faculty of Medicine, Sherbrooke University Hospital Center, Sherbrooke, Quebec, Canada
| | - Giulio Del-Popolo
- Department of Neurourology, Careggi University Hospital, Florence, Italy
| | | | - Claire Vilain
- R&D, Clinical Development Operations Department, Biostatistics and Sataistical Programing Group, Ipsen Innovation, Les Ulis, France
| | - Magali Volteau
- R&D, Clinical Development Operations Department, Biostatistics and Sataistical Programing Group, Ipsen Innovation, Les Ulis, France
| | - Michael Kennelly
- Department of Urology, Atrium Health, Carolinas Medical Center, Charlotte, North Carolina, USA
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Lee J, Chun MH, Ko YJ, Lee SU, Kim DY, Paik NJ. Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial. Medicine (Baltimore) 2022; 101:e31367. [PMID: 36343044 PMCID: PMC9646656 DOI: 10.1097/md.0000000000031367] [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] [Indexed: 11/09/2022] Open
Abstract
BACKGROUND Botulinum toxin type A injection is widely used treatment option for the treatment of upper limb spasticity in stroke patients. The purpose of this study was to explore the safety and efficacy of MT10107, a new botulinum toxin type A, in patients with post-stroke upper limb spasticity. METHODS A prospective, randomized, double-blind, active drug-controlled, multi-center, phase I clinical trial. Thirty patients with post-stroke upper limb spasticity were received either MT10107 or onabotulinumtoxinA. Primary endpoint was change of modified Ashworth scale (MAS) score for wrist flexor from baseline to week 4. The secondary endpoints were changes of MAS scores for elbow and finger flexors, response rate, Disability Assessment Scale (DAS), and global assessment of treatment. The safety endpoints such as adverse events, vital signs, physical examination, and laboratory test were evaluated. The outcome measures were evaluated from baseline to week 4. RESULTS The primary endpoints were -1.07 ± 0.70 and -1.23 ± 0.56 for the MT10107 and onabotulinumtoxinA groups, respectively. The intergroup difference of change between the 2 groups was 0.17 (95% confidence interval -0.31 to 0.64, P = .5769). In secondary endpoints, both groups showed a significant improvement in both MAS and DAS. There was no significant between-group difference in all secondary endpoints and safety measures. CONCLUSION The safety and efficacy of MT10107 showed no significant difference compared to onabotulinumtoxinA in post-stroke upper limb spasticity treatment.
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Affiliation(s)
- Junekyung Lee
- Department of Rehabilitation Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Republic of Korea
| | - Min Ho Chun
- Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
| | - Young Jin Ko
- Department of Rehabilitation Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| | - Shi-Uk Lee
- Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea
| | - Deog Young Kim
- Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Nam-Jong Paik
- Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
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Lee J, Chun MH. Safety and Efficacy of HU-014 in the Treatment of Post-Stroke Upper Limb Spasticity: A Phase I Pilot Study. Toxins (Basel) 2022; 14:toxins14110730. [PMID: 36355980 PMCID: PMC9693132 DOI: 10.3390/toxins14110730] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2022] [Revised: 10/19/2022] [Accepted: 10/22/2022] [Indexed: 01/26/2023] Open
Abstract
Botulinum toxin type A (BTX-A) is widely used for treating post-stroke upper limb spasticity. We evaluated the safety and efficacy of HU-014 in treating post-stroke upper limb spasticity. Thirteen patients were administered with HU-014. The primary outcome was safety, including adverse events, vital signs, physical examination, laboratory tests, and antibody formation test. The secondary outcomes were changes in the Modified Ashworth Scale (MAS) score for wrist, elbow, and finger flexor; Disability Assessment Scale (DAS); Investigator's Global Assessment (IGA) and Subject's Global Assessment (SGA); Caregiver Burden Scale (CBS); and Columbia Suicide Severity Rating Scale (C-SSRS) at weeks 4, 8, and 12 from baseline. No notable safety-related issues were reported. MAS and DAS scores were significantly decreased from those at baseline at 4, 8, and 12 weeks (p < 0.05). At weeks 4, 8, and 12, the IGA and SGA scores were 5.85 ± 0.55, 5.69 ± 0.48, and 5.62 ± 0.65 and 5.46 ± 1.20, 5.85 ± 0.38, and 5.77 ± 0.73, respectively. CBS scores decreased at all timepoints and those for cutting fingernails significantly decreased at 8 and 12 weeks compared with baseline (p < 0.05). C-SSRS scores showed that suicidal ideation in all patients was "low" at all timepoints. HU-014 is a safe treatment that can improve post-stroke upper limb spasticity.
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Effects of Peripheral Electromagnetic Fields on Spasticity: A Systematic Review. J Clin Med 2022; 11:jcm11133739. [PMID: 35807019 PMCID: PMC9267146 DOI: 10.3390/jcm11133739] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2022] [Revised: 06/22/2022] [Accepted: 06/23/2022] [Indexed: 02/05/2023] Open
Abstract
Electromagnetic fields are emerging as a therapeutic option for patients with spasticity. They have been applied at brain or peripheral level. The effects of electromagnetic fields applied to the brain have been extensively studied for years in spasticity, but not so at the peripheral level. Therefore, the purpose of our work is to analyze the effects of electromagnetic fields, applied peripherally to spasticity. A systematic review was conducted resulting in 10 clinical trials. The frequency ranged from 1 Hz to 150 Hz, with 25 Hz being the most commonly used and the intensity it was gradually increased but there was low homogeneity in how it was increased. Positive results on spasticity were found in 80% of the studies: improvements in stretch reflex threshold, self questionnaire about difficulties related to spasticity, clinical spasticity score, performance scale, Ashworth scale, spastic tone, Hmax/Mmax Ratio and active and passive dorsal flexion. However, results must be taken with caution due to the large heterogeneity and the small number of articles. In future studies, it would be interesting to agree on the parameters to be used, as well as the way of assessing spasticity, to be more objective in the study of their effectiveness.
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Botox Injections in Paraspinal Muscles Result in Low Maximal Specific Force and Shortening Velocity in Fast but Not Slow Skinned Muscle Fibers. Spine (Phila Pa 1976) 2022; 47:833-840. [PMID: 34265813 DOI: 10.1097/brs.0000000000004162] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
STUDY DESIGN Basic science, experimental animal study. OBJECTIVE To determine the effects of Botulinum toxin type A (BTX-A) injections on the mechanical properties of skinned muscle fibers (cells) of rabbit paraspinal muscles. SUMMARY OF BACKGROUND DATA BTX-A has been widely used in the treatment of disorders of muscle hyperactivity, such as spasticity, dystonia, and back pain. However, BTX-A injection has been shown to cause muscle atrophy, fat infiltration, and decreased force output in target muscles, but its potential effects on the contractile machinery and force production on the cellular level remain unknown. METHODS Nineteen-month-old, male New Zealand White Rabbits received either saline or BTX-A injections into the paraspinal muscles, equally distributed along the left and right sides of the spine at T12, L1, and L2 at 0, 8, 12, 16, 20, and 24 weeks. Magnetic resonance imaging was used to quantify muscle crosssectional area and structural changes before and at 28 weeks following the initial injection. Skinned fibers isolated from the paraspinal muscles were tested for their active and passive force-length relationships, unloaded shortening velocity, and myosin heavy chain isoforms. RESULTS BTX-A injections led to significant fat infiltration within the injected muscles and a greater proportion of IIa to IIx fibers. Isolated fast fibers from BTX-A injected animals had lower active force and unloaded shortening velocity compared with fibers from saline-injected control animals. Force and velocity properties were not different between groups for the slow fibers. CONCLUSION Injection of BTX-A into the paraspinal rabbit muscles leads to significant alterations in the contractile properties of fast, but not slow, fibers.Level of Evidence: N/A.
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Bäcker HC, Freibott CE, Swart E, Perka C, Jobin CM, Rosenwasser MP. A novel treatment for prevention of post-traumatic elbow stiffness using onaBotulinum toxin type A: a prospective placebo controlled randomized trial. Acta Orthop Belg 2021. [DOI: 10.52628/87.3.17] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
Approximately 30% of all upper extremity fractures are elbow fractures which may result elbow stiffness. This study aimed to investigate the efficacy of onaBotulinum Toxin type A injection to prevent post-traumatic pain and elbow-stiffness. All patients were included who presented to a single surgeon with supracondylar/ intraarticular distal humerus fractures, proximal ulna and radius fractures. The study was developed in a randomized placebo controlled study between 2003-2007. The Disabilities of the Arm, Shoulder, and Hand (DASH) score as well as the arc-of-motion (AOM) were assessed after three, six, twelve-months and final follow up for evaluation. Of the 31-patients included, 15-patients (48.4%) received Botox injections. In all patients no complication was observed when injecting a dosage 100-units for the brachialis and biceps brachii muscles. Furthermore, it was an effective method to prevent post-traumatic elbow stiffness, lasting six- months. Significant differences in DASH, VAS-score and ROM after three-months between the Botox and control group (DASH 21.6±11.0 vs. 55.3±11.0 ; VAS 1.2±5.2 vs. 5.7±21.9 ; ROM 103±7.6 vs. 73±6.3 ; p>0.05) were identified in the prospective group. Botulinum toxin is a safe, reliable and effective treatment to prevent post-traumatic elbow stiffness.
Our study demonstrates improved early range-of- motion (p<0.05), better extension after 6 weeks and improved functional outcome including VAS and DASH score (p<0.05).
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Long-term BTX-A effects on bi-articular muscle: Higher passive force, limited length range of active force production and unchanged intermuscular interactions. J Biomech 2021; 126:110627. [PMID: 34293603 DOI: 10.1016/j.jbiomech.2021.110627] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2021] [Accepted: 07/05/2021] [Indexed: 11/22/2022]
Abstract
Botulinum toxin type-A (BTX-A) is commonly used for spasticity management aiming at reducing joint stiffness and increasing joint range of motion in CP patients. However, previous animal studies showed acutely increased passive forces and a narrowerlength range of active force exertion (lrange) for muscles exposed. BTX-A can spread affecting mechanics of several muscles in a compartment, but it was shown acutely to diminishepimuscular myofascial force transmission (EMFT). Yet, our understanding of these effects in the long-term is limited and they need to be tested in a bi-articular muscle. The goal was to test the following hypotheses in a long-term rat model: exposure to BTX-A (i) has no effects onlrangeand passive forces of bi-articular extensor digitorum longus (EDL) muscle and (ii) diminishes EMFT. Male Wistar rats were divided into two groups: BTX-A and control (0.1 units of BTX-A or only saline was injected into the tibialis anterior). Isometric proximal and distal EDL forces were measured simultaneously, one-month post-injection. Proximally and distally lengthening the muscle showed that BTX-A causes a significantly narrowerlrange(by 14.7% distally and 32.2% proximally) and significantly increased passive muscle forces (over 2-fold both distally and proximally). Altering muscle position at constant length showed that BTX-A does not change EMFT. The findings reject both hypotheses showing that long-term exposure to BTX-A compromises bi-articular muscle's contribution to motion for both joints and the muscle's mechanical interaction with the surroundings remains unaffected. These effects which may compromise long-term spasticity management should be studied in CP patients.
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Turner LD, Nielsen AL, Lin L, Pellett S, Sugane T, Olson ME, Johnson EA, Janda KD. Irreversible inhibition of BoNT/A protease: proximity-driven reactivity contingent upon a bifunctional approach. RSC Med Chem 2021; 12:960-969. [PMID: 34223161 PMCID: PMC8221255 DOI: 10.1039/d1md00089f] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/12/2021] [Accepted: 05/03/2021] [Indexed: 12/27/2022] Open
Abstract
Botulinum neurotoxin A (BoNT/A) is categorized as a Tier 1 bioterrorism agent and persists within muscle neurons for months, causing paralysis. A readily available treatment that abrogates BoNT/A's toxicity and longevity is a necessity in the event of a widespread BoNT/A attack and for clinical treatment of botulism, yet remains an unmet need. Herein, we describe a comprehensive warhead screening campaign of bifunctional hydroxamate-based inhibitors for the irreversible inhibition of the BoNT/A light chain (LC). Using the 2,4-dichlorocinnamic hydroxamic acid (DCHA) metal-binding pharmacophore modified with a pendent warhead, a total of 37 compounds, possessing 13 distinct warhead types, were synthesized and evaluated for time-dependent inhibition against the BoNT/A LC. Iodoacetamides, maleimides, and an epoxide were found to exhibit time-dependent inhibition and their k GSH measured as a description of reactivity. The epoxide exhibited superior time-dependent inhibition over the iodoacetamides, despite reacting with glutathione (GSH) 51-fold slower. The proximity-driven covalent bond achieved with the epoxide inhibitor was contingent upon the vital hydroxamate-Zn2+ anchor in placing the warhead in an optimal position for reaction with Cys165. Monofunctional control compounds exemplified the necessity of the bifunctional approach, and Cys165 modification was confirmed through high-resolution mass spectrometry (HRMS) and ablation of time-dependent inhibitory activity against a C165A variant. Compounds were also evaluated against BoNT/A-intoxicated motor neuron cells, and their cell toxicity, serum stability, and selectivity against matrix metalloproteinases (MMPs) were characterized. The bifunctional approach allows the use of less intrinsically reactive electrophiles to intercept Cys165, thus expanding the toolbox of potential warheads for selective irreversible BoNT/A LC inhibition. We envision that this dual-targeted strategy is amenable to other metalloproteases that also possess non-catalytic cysteines proximal to the active-site metal center.
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Affiliation(s)
- Lewis D Turner
- Departments of Chemistry and Immunology, The Skaggs Institute for Chemical Biology, Worm Institute of Research and Medicine (WIRM), Scripps Research 10550 N Torrey Pines Road La Jolla CA 92037 USA
| | - Alexander L Nielsen
- Departments of Chemistry and Immunology, The Skaggs Institute for Chemical Biology, Worm Institute of Research and Medicine (WIRM), Scripps Research 10550 N Torrey Pines Road La Jolla CA 92037 USA
- Center for Biopharmaceuticals & Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen Universitetsparken 2 DK-2100 Copenhagen Denmark
| | - Lucy Lin
- Departments of Chemistry and Immunology, The Skaggs Institute for Chemical Biology, Worm Institute of Research and Medicine (WIRM), Scripps Research 10550 N Torrey Pines Road La Jolla CA 92037 USA
| | - Sabine Pellett
- Department of Bacteriology, University of Wisconsin 1550 Linden Drive Madison WI 53706 USA
| | - Takashi Sugane
- Departments of Chemistry and Immunology, The Skaggs Institute for Chemical Biology, Worm Institute of Research and Medicine (WIRM), Scripps Research 10550 N Torrey Pines Road La Jolla CA 92037 USA
| | - Margaret E Olson
- Departments of Chemistry and Immunology, The Skaggs Institute for Chemical Biology, Worm Institute of Research and Medicine (WIRM), Scripps Research 10550 N Torrey Pines Road La Jolla CA 92037 USA
- College of Pharmacy, Roosevelt University Schaumburg IL 60173 USA
| | - Eric A Johnson
- Department of Bacteriology, University of Wisconsin 1550 Linden Drive Madison WI 53706 USA
| | - Kim D Janda
- Departments of Chemistry and Immunology, The Skaggs Institute for Chemical Biology, Worm Institute of Research and Medicine (WIRM), Scripps Research 10550 N Torrey Pines Road La Jolla CA 92037 USA
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Lee J, Chun MH, Ko YJ, Lee SU, Kim DY, Paik NJ, Kwon BS, Park YG. Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial. Arch Phys Med Rehabil 2020; 101:1485-1496. [PMID: 32497599 DOI: 10.1016/j.apmr.2020.03.025] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2019] [Revised: 03/29/2020] [Accepted: 03/31/2020] [Indexed: 11/28/2022]
Abstract
OBJECTIVE To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DESIGN: Prospective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial. SETTING Seven university hospitals in the Republic of Korea. PARTICIPANTS Patients (N=220) with poststroke upper limb spasticity. INTERVENTIONS All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group). MAIN OUTCOME MEASURES The primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention. RESULTS The primary outcome was found to be -1.32±0.69 and -1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures. CONCLUSIONS MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.
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Affiliation(s)
- Junekyung Lee
- Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul
| | - Min Ho Chun
- Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
| | - Young Jin Ko
- Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul
| | - Shi-Uk Lee
- Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul
| | - Deog Young Kim
- Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul
| | - Nam-Jong Paik
- Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam
| | - Bum Sun Kwon
- Department of Rehabilitation Medicine, Dongguk University Ilsan Hospital, Goyang
| | - Yoon Ghil Park
- Department of Rehabilitation Medicine, Gangnam Severance Hospital Yonsei University College of Medicine, Seoul, Republic of Korea
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Botulinum toxin A injection in the management of shoulder muscle overactivity: A scoping review. BRAIN IMPAIR 2019. [DOI: 10.1017/brimp.2019.14] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022]
Abstract
AbstractThe majority of studies examining botulinum toxin A (BTX-A) in the management of upper limb muscle overactivity and pain focus on the distal arm and hand. Research has begun to look at BTX-A efficacy in more proximal upper limb muscles, with literature showing equivocal findings. This scoping review identified 15 studies meeting inclusion criteria whose data were examined against three outcome variables: muscle overactivity, range of movement and pain. Overall, while the majority of injected participants improved on these variables, between-study methodological variability such as research design potentially underpowered studies and arbitrary decision making gave a high likelihood of influencing the interpretation of their results. Future research is warranted, with a robust focus on functional anatomy, a critical appraisal of how BTX-A may help the individual being studied and utilising individualised rather than protocol-driven research paradigms.
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Abstract
Surgery is one element of the rehabilitative care of the spastic upper limb. Different surgical techniques have been advocated to address each of the common deformities and underlying causes, including muscle spasticity, joint contracture, and paralysis. Partial neurectomy of motor nerves has been shown to reduce spasticity in the target muscles. It is effective only for the spastic component of the deformity, which underscores the importance of a preliminary thorough clinical examination. Hyperselective neurectomy, which involves performing a partial division of each motor ramus at its entry point into the target muscle, results in improved selectivity, reliable partial muscle denervation, and durable results.
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Affiliation(s)
- Caroline Leclercq
- Institut de la Main, Clinique Bizet, 21 rue Georges Bizet, Paris 75116, France.
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17
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Wang R, Gäverth J, Herman PA. Changes in the Neural and Non-neural Related Properties of the Spastic Wrist Flexors After Treatment With Botulinum Toxin A in Post-stroke Subjects: An Optimization Study. Front Bioeng Biotechnol 2018; 6:73. [PMID: 29963551 PMCID: PMC6013585 DOI: 10.3389/fbioe.2018.00073] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2018] [Accepted: 05/22/2018] [Indexed: 11/13/2022] Open
Abstract
Quantifying neural and non-neural contributions to the joint resistance in spasticity is essential for a better evaluation of different intervention strategies such as botulinum toxin A (BoTN-A). However, direct measurement of muscle mechanical properties and spasticity-related parameters in humans is extremely challenging. The aim of this study was to use a previously developed musculoskeletal model and optimization scheme to evaluate the changes of neural and non-neural related properties of the spastic wrist flexors during passive wrist extension after BoTN-A injection. Data of joint angle and resistant torque were collected from 21 chronic stroke patients before, and 4 and 12 weeks post BoTN-A injection using NeuroFlexor, which is a motorized force measurement device to passively stretch wrist flexors. The model was optimized by tuning the passive and stretch-related parameters to fit the measured torque in each participant. It was found that stroke survivors exhibited decreased neural components at 4 weeks post BoNT-A injection, which returned to baseline levels after 12 weeks. The decreased neural component was mainly due to the increased motoneuron pool threshold, which is interpreted as a net excitatory and inhibitory inputs to the motoneuron pool. Though the linear stiffness and viscosity properties of wrist flexors were similar before and after treatment, increased exponential stiffness was observed over time which may indicate a decreased range of motion of the wrist joint. Using a combination of modeling and experimental measurement, valuable insights into the treatment responses, i.e., transmission of motoneurons, are provided by investigating potential parameter changes along the stretch reflex pathway in persons with chronic stroke.
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Affiliation(s)
- Ruoli Wang
- Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.,Department of Mechanics, Royal Institute of Technology, Stockholm, Sweden.,KTH Biomex Center, Royal Institute of Technology, Stockholm, Sweden
| | - Johan Gäverth
- Functional Area Occupational Therapy & Physiotherapy, Karolinska University Hospital, Stockholm, Sweden
| | - Pawel A Herman
- Department of Computational Science and Technology, Royal Institute of Technology, Stockholm, Sweden
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Ma CZH, Zheng YP, Lee WCC. Changes in gait and plantar foot loading upon using vibrotactile wearable biofeedback system in patients with stroke. Top Stroke Rehabil 2017; 25:20-27. [PMID: 28950803 DOI: 10.1080/10749357.2017.1380339] [Citation(s) in RCA: 29] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Abstract
BACKGROUND Patients with stroke walk with excessive foot inversion at the affected side, which may disturb their balance and gait. OBJECTIVES This study aimed to investigate the effects of instant biofeedback of plantar force at the medial and lateral forefoot regions on gait and plantar foot loading in patients with stroke. METHODS A total of eight patients with hemiplegic stroke, who had flexible rearfoot varus deformity at the affected side, participated in this study. A vibrotactile biofeedback system was developed and evaluated. It analyzed forces at the medial and lateral forefeet, and instantly provided vibration clues when the plantar force at medial forefoot was less than a threshold. Each subject's three-dimensional gait parameters and plantar-pressure distribution during walking were measured under two experimental conditions (sequence randomized): with and without the device turned on (Trial-registration number: ChiCTR-IPB-15006530 and HKCTR-1853). RESULTS Providing biofeedback significantly reduced the foot inversion and increased the mid-stance foot-floor contact area and medial midfoot plantar pressure of the affected limb, bringing the values of these parameters closer to those of the unaffected side. The biofeedback also significantly reduced the unaffected side's excessive knee flexion and hip abduction. CONCLUSIONS There were signs of improved foot loading characteristics and gait upon provision of instant vibrotactile biofeedback of plantar force. The positive results of this study further support the development of wearable biofeedback devices for improving gait of patients with stroke.
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Affiliation(s)
- Christina Zong-Hao Ma
- a Interdisciplinary Division of Biomedical Engineering , The Hong Kong Polytechnic University , Hong Kong SAR , China.,b Rehabilitation Engineering Research Institute, China Rehabilitation Research Center , Beijing , China
| | - Yong-Ping Zheng
- a Interdisciplinary Division of Biomedical Engineering , The Hong Kong Polytechnic University , Hong Kong SAR , China
| | - Winson Chiu-Chun Lee
- a Interdisciplinary Division of Biomedical Engineering , The Hong Kong Polytechnic University , Hong Kong SAR , China.,c School of Mechanical, Materials, Mechatronic and Biomedical Engineering , University of Wollongong , Wollongong , Australia
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Karakkattil P, Trudelle-Jackson E, Brown HH, Hammontree P, Okolo M. Outcomes of Botulinum Toxin Type A for equinovarus deformity in patients with CVA: A case series. Physiother Theory Pract 2017; 33:410-419. [PMID: 28481738 DOI: 10.1080/09593985.2017.1318420] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
BACKGROUND There is evidence that Botulinum Toxin-A (BTX-A) reduces focal spasticity associated with equinovarus to improve gait in patients poststroke. However, there is little research examining whether gait improvements are maintained after the effectiveness period of BTX-A injections. The purpose of this observational study was to determine whether there was a difference in gait parameters in three patients before BTX-A injection versus four and ten weeks after. CASE SERIES Three women, ages 63, 60, and 42 postischemic stroke with hemiparesis and equinovarus underwent measurements for: plantar flexor spasticity, ankle dorsiflexion ROM, temporal-spatial gait parameters, and gait endurance. All participants improved in ankle ROM. At week 10, spasticity had returned to initial measurement levels in participants A and C. Base of support and step length symmetry ratios did not improve following injections. Participants A and B, who received physical therapy during the study, showed modest gains in gait endurance and velocity. CONCLUSION Although BTX-A injections improved spasticity, this improvement did not translate to gait outcomes. Addition of physical therapy interventions appeared to improve gait outcomes in this case series. We suggest future randomized control studies to compare effects of physical therapy alone to BTX-A combined with physical therapy on gait outcomes.
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Affiliation(s)
- Priya Karakkattil
- a Baylor Institute for Rehabilitation , Outpatient Rehabilitation Services , Frisco , TX , USA.,b School of Physical Therapy , Texas Woman's University , Dallas , TX , USA
| | | | | | - Patrick Hammontree
- b School of Physical Therapy , Texas Woman's University , Dallas , TX , USA
| | - Mary Okolo
- b School of Physical Therapy , Texas Woman's University , Dallas , TX , USA
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Krylova LV, Khasanova DR. The features of botulinum therapy for different patterns of poststroke spasticity. Zh Nevrol Psikhiatr Im S S Korsakova 2017; 117:42-48. [DOI: 10.17116/jnevro20171172142-48] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
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Rosales RL, Efendy F, Teleg ESA, Delos Santos MMD, Rosales MCE, Ostrea M, Tanglao MJ, Ng AR. Botulinum toxin as early intervention for spasticity after stroke or non-progressive brain lesion: A meta-analysis. J Neurol Sci 2016; 371:6-14. [DOI: 10.1016/j.jns.2016.10.005] [Citation(s) in RCA: 48] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2016] [Revised: 10/01/2016] [Accepted: 10/06/2016] [Indexed: 11/28/2022]
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Amini M, Shamili A, Frough B, Pashmdarfard M, Fallahzadeh Abarghouei A. Combined effect of botulinum toxin and splinting on motor components and function of people suffering a stroke. Med J Islam Repub Iran 2016; 30:373. [PMID: 27493917 PMCID: PMC4972075] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/04/2015] [Accepted: 01/27/2016] [Indexed: 12/02/2022] Open
Abstract
BACKGROUND Spasticity is one of the problems after a stroke. Due to this increase in muscle tone, patients are confronted with problems in motor control and difficulties in activities of daily living and complications such as shortness and contracture. The aim of this study was to examine the effects of the simultaneous use of both splint and botulinum toxin-A (BTX-A) injection on spasticity, range of motion and upper extremity function in a 3-month period. METHODS In this study a comparison was done between three groups of interventions, conducted in rehabilitation clinics in Tehran. Sixty people with chronic stroke were recruited. Based on the inclusion criteria, a total of 39 stroke patients after completing the consent forms were entered to intervention groups; splint or botulinum toxin injection or combined splint/botulinum toxin injection. They were followed up about three months and the evaluations were done monthly. Goniometry was the method to measure the range of motion, and Modified Ashworth Scale was used to examine the spasticity and the upper extremity function was scored based on Fugl- Meyer Assessment. Statistical analysis was done using SPSS 17. And ANOVAs was used for comparison between groups and times. Significance was set at 0.05. RESULTS All outcome measures were improved within each group but the differences between splint group and BTX-A group and the BTX-A-splint group was not significant in most outcomes during the 3 periods (first evaluation until end of the first month, the end of first month until the end of second month, the end of second month until the end of the third month) (p>0.05). The results also showed that the changes in elbow`s spasticity (p=0.05) and wrist`s spasticity (p=0.007) and upper extremity function (p=0.04) were obvious between the three groups over the 3-months and the difference in the group of combined use of botulinum toxin, and the splint was more than other groups. CONCLUSION In this study, the effects of botulinum toxin injection and Volar-Dorsal Wrist/Hand Immobilization splint and the combined use of botulinum injection and splint were obvious in all groups but was not significantly different between the interventions in a 3-month follow-up.
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Affiliation(s)
- Malek Amini
- 1 Assistant Professor, Occupational Therapy Department, Faculty of Rehabilitation, Iran University of Medical Sciences, Tehran, Iran.
| | - Aryan Shamili
- 2 PhD student of Occupational Therapy, Iran University of Medical Sciences, Tehran, Iran, & Lecturer at Rehabilitation Faculty and Neurosciences Research Center (NSRC), Tabriz University of Medical Sciences, Tabriz, Iran. ,
Corresponding author) PhD student of Occupational Therapy, Iran University of Medical Sciences, Tehran, Iran, & Lecturer at Rehabilitation Faculty and Neurosciences Research Center (NSRC), Tabriz University of Medical Sciences, Tabriz, Iran.
| | - Bijan Frough
- 3 Professor of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran.
| | - Marzieh Pashmdarfard
- 4 Occupational Therapy Department, Zanjan University of Medical Sciences, Zanjan, Iran.
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Usuki F, Tohyama S. Three Case Reports of Successful Vibration Therapy of the Plantar Fascia for Spasticity Due to Cerebral Palsy-Like Syndrome, Fetal-Type Minamata Disease. Medicine (Baltimore) 2016; 95:e3385. [PMID: 27082608 PMCID: PMC4839852 DOI: 10.1097/md.0000000000003385] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/27/2022] Open
Abstract
Fetal-type Minamata disease is caused by the exposure to high concentrations of methylmercury in the fetal period and shows cerebral palsy-like clinical features. Relief of spasticity is a major task of rehabilitation to improve their activities of daily living. Here we report the effect of long-term vibration therapy on bilateral lower-limb spasticity in 3 patients with fetal-type Minamata disease. We used a simple, inexpensive, and noninvasive approach with hand-held vibration massagers, which were applied to the plantar fascia at 90 Hz for 15 minutes. The effect was observed soon after the first treatment and resulted in better performance of the repetitive facilitation. Vibration therapy for 1 year improved Modified Ashworth Scale for the ankle flexors in 2 cases. The labored gait improved and gait speed increased in another case. Continued vibration therapy for another 1 year further improved Modified Ashworth Scale score and range of motion of ankle dorsiflexion in 1 case. This case showed the decreased amplitude of soleus H-reflex after the 15-minute vibration therapy, suggesting that α-motor neuron excitability was suppressed. Vibration therapy using a hand-held vibration massager may offer safe and effective treatment for lower-limb spasticity in patients with chronic neurological disorders.
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Affiliation(s)
- Fusako Usuki
- From the Department of Clinical Medicine, National Institute for Minamata Disease, Minamata, Kumamoto, Japan
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Wu T, Li JH, Song HX, Dong Y. Effectiveness of Botulinum Toxin for Lower Limbs Spasticity after Stroke: A Systematic Review and Meta-Analysis. Top Stroke Rehabil 2016; 23:217-23. [DOI: 10.1080/10749357.2016.1139294] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/24/2023]
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Lim YH, Choi EH, Lim JY. Comparison of Effects of Botulinum Toxin Injection Between Subacute and Chronic Stroke Patients: A Pilot Study. Medicine (Baltimore) 2016; 95:e2851. [PMID: 26886649 PMCID: PMC4998649 DOI: 10.1097/md.0000000000002851] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Abstract
The aim of this study was to compare the effects of botulinum toxin injection between subacute and chronic stroke patients. Eighteen stroke patients (9 subacute and 9 chronic) with spasticity of 1+ or higher in the hemiplegic elbow or wrist joint, based on the modified Ashworth scale were recruited. Modified Ashworth scale, modified Tardieu scale, manual muscle testing, passive range of motion, Brunnstrom stage, modified Barthel index, and Fugl-Meyer scale evaluations of the hemiplegic upper extremity were performed just before the injection and 4 weeks later. A total dose of 200 U of botulinum toxin type A was injected into each patient. One or more of the elbow flexor muscles and one or more of the wrist flexor or finger flexor muscles were included. Modified Ashworth scale, manual muscle testing, passive range of motion, and modified Barthel index results were improved in subacute patients only. However, modified Tardieu scale for the elbow and Fugl-Meyer scale results were improved in both groups, and the improvement was comparable. In conclusion, botulinum toxin injection in subacute patients was more helpful for spasticity, contracture, and function than in chronic patients. However, beneficial effects of botulinum toxin injection on spasticity and function in chronic patients were found in the assessments of the modified Tardieu scale and Fugl-Meyer scale.
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Affiliation(s)
- Young-Ho Lim
- From the Department of Rehabilitation Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Gangwon-do, Republic of Korea
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Dursun E, Dursun N. Evaluation of dance therapy effects on gait pattern in patients with previous cerebrovascular events: Randomized study results from a single center. ACTA ACUST UNITED AC 2016. [DOI: 10.5348/d05-2016-19-oa-15] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022]
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Barakat MI, Elhady W, Gouda M, Taha M, Metwaly I. Surgical management of intractable spasticity. 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 2015; 25:928-35. [PMID: 26667812 DOI: 10.1007/s00586-015-4326-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/19/2015] [Revised: 11/10/2015] [Accepted: 11/10/2015] [Indexed: 10/22/2022]
Abstract
BACKGROUND Spasticity is motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyper-excitability of the stretch reflex, as one component of the upper motor neuron syndrome. PURPOSE This study aimed at comparing between spinally based (dorsal rhizotomy) versus peripherally based (selective neurotomy) surgical procedures in management of hypertonia in the lower limbs of pediatrics. METHODS Over a 3-year period, 50 children with intractable, lower limb spasticity were prospectively treated by selective neurotomy (group A, 35 patients) and dorsal rhizotomy (group B, 15 patients) with 6 months' follow-up period. RESULTS The operative duration was longer with dorsal rhizotomy with mean of 292.2 min versus 76.8 min with neurotomy (P = 0.001) and the hospital stay of dorsal rhizotomy was longer with mean of 6.2 days versus 1.7 days with neurotomy (P = 0.001). Muscles power exhibited significant improvement in 53.3% of the total rhizotomies (P = 0.001). Following neurotomies; muscle tone showed marked improvement in 69.3% muscles which had normal tone and 31.9% of muscles had mild spasticity (P = 0.001). The H/M ratio following dorsal rhizotomies showed marked reduction of the ratio, and the mean was 0.11 versus 0.58 preoperatively. CONCLUSION Both neurotomies and dorsal rhizotomies were safe surgical procedures and were provided with good improvement in respect of: muscle power, severity of spasticity, patient's ambulation, gait, range of joint movement, associated pain, functional disability, and nerve excitability with no significant difference between both procedures.
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Affiliation(s)
- Mohamed I Barakat
- Neurosurgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
| | - Waleed Elhady
- Neurosurgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
| | - Mohamed Gouda
- Neurosurgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
| | - Mahmoud Taha
- Neurosurgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
| | - Ibrahim Metwaly
- Neurosurgery Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
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Abogunrin S, Hortobagyi L, Remak E, Dinet J, Gabriel S, Bakheit AMO. Budget impact analysis of botulinum toxin A therapy for upper limb spasticity in the United Kingdom. CLINICOECONOMICS AND OUTCOMES RESEARCH 2015; 7:185-93. [PMID: 25878510 PMCID: PMC4386804 DOI: 10.2147/ceor.s76141] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
Background Botulinum toxin A (BoNT-A) is an effective treatment for patients with upper limb spasticity (ULS), which is a debilitating feature of upper motor neuron lesions. BoNT-A preparations available in the UK are associated with different costs. Methods We developed a budget impact model to assess the effect of changing market shares of different BoNT-A formulations – abobotulinumtoxinA, onabotulinumtoxinA, and incobotulinumtoxinA – and best supportive care, from the UK payer perspective, over a 5-year time horizon. Epidemiological and resource use data were derived from published literature and clinical expert opinion. One-way sensitivity analyses were performed to determine parameters most influential on budget impact. Results Base-case assumptions showed that an increased uptake of abobotulinumtoxinA resulted in a 5-year savings of £6,283,829. Treatment with BoNT-A costs less than best supportive care per patient per year, although treating a patient with onabotulinumtoxinA (£20,861) and incobotulinumtoxinA (£20,717) cost more per patient annually than with abobotulinumtoxinA (£19,800). Sensitivity analyses showed that the most influential parameters on budget were percentage of cerebral palsy and stroke patients developing ULS, and the prevalence of stroke. Conclusion Study findings suggest that increased use of abobotulinumtoxinA for ULS in the UK could potentially reduce total ULS cost for the health system and society.
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Affiliation(s)
| | | | - Edit Remak
- Health Economics, Evidera, Budapest, Hungary, France
| | - Jerome Dinet
- Health Economics and Outcomes Research (Global), Ipsen Pharma, Boulogne-Billancourt, France
| | - Sylvie Gabriel
- Global Market Access and Pricing, Ipsen Pharma, Boulogne-Billancourt, France
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Zhao W, Wang C, Li Z, Chen L, Li J, Cui W, Ding S, Xi Q, Wang F, Jia F, Xiao S, Guo Y, Zhao Y. Efficacy and safety of transcutaneous electrical acupoint stimulation to treat muscle spasticity following brain injury: a double-blinded, multicenter, randomized controlled trial. PLoS One 2015; 10:e0116976. [PMID: 25643051 PMCID: PMC4314074 DOI: 10.1371/journal.pone.0116976] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2014] [Accepted: 12/07/2014] [Indexed: 11/18/2022] Open
Abstract
Objective This study was aimed at evaluating the clinical efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) to treat muscle spasticity after brain injury (Chinese Clinical Trial Registry: ChiCTR-TRC-11001310). Methods A total of 60 patients with muscle spasticity after brain injury were randomized to the following 3 groups: 100, 2, and 0 Hz (sham) TEAS. The acupoints Hegu (LI4)—Yuji (LU10) and Zusanli (ST36)—Chengshan (BL57) on the injured side were stimulated at 0, 2, or 100 Hz, 5 times per week for 4 weeks. The patients were followed up for 1 and 2 months after the treatments. The effects of the treatments on muscle spasticity at the wrist, thumb, the other 4 fingers, elbow, shoulder, knee, and ankle were evaluated by the Modified Ashworth Scale, and the effects on disability were assessed by the Disability Assessment Scale. The walking capability was evaluated by the Holden functional ambulation classification score. The overall performance was assessed by the Global Assessment Scale score and the improved Barthel Index. The safety of the treatments administered was also monitored. Results The wrist spasticity was significantly reduced from baseline at weeks 2, 3, and 4 of treatment and at the 1- and 2-month follow-up visits in the 100 Hz group (P < 0.01). Compared with 2 Hz or sham TEAS, 100 Hz TEAS decreased wrist spasticity at weeks 2, 3, and 4 of treatment and 1 month after treatment (P < 0.001). The other endpoints were not affected by the treatments. No treatment-emergent adverse events were reported during treatments and follow-up visits. Conclusions TEAS appears to be a safe and effective therapy to relieve muscle spasticity after brain injury, although large-scale studies are required to further verify the findings. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-11001310 http://www.chictr.org
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Affiliation(s)
- Wenli Zhao
- Department of Neurology, Tianjin Nankai Hospital, Tianjin, 300100, China
| | - Chao Wang
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Zhongzheng Li
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Lei Chen
- Department of Acupuncture and Moxibustion, Tianjin Ninghe Hospital, Tianjin, 301500, China
| | - Jianbo Li
- Department of Acupuncture and Moxibustion, Tianjin Ninghe Hospital, Tianjin, 301500, China
| | - Weidong Cui
- Department of Acupuncture and Moxibustion, Tianjin Ninghe Hospital, Tianjin, 301500, China
| | - Shasha Ding
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Qiang Xi
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Fan Wang
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Fei Jia
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Shuhua Xiao
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Yi Guo
- Department of Acupuncture and Moxibustion, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China
| | - Ye Zhao
- Department of Clinical Research, Tianjin Nankai Hospital and Tianjin Academy of Integrative Medicine, Tianjin, 300100, China
- * E-mail:
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Effect of botulinum toxin type-A in patients with focal spasticity. North Clin Istanb 2015; 1:153-157. [PMID: 28058322 PMCID: PMC5175034 DOI: 10.14744/nci.2014.43531] [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: 09/11/2014] [Accepted: 11/18/2014] [Indexed: 11/21/2022] Open
Abstract
OBJECTIVE: To investigate the effect of botulinum toxin type-A (BTX-A) on spasticity and function in patients with focal spasticity. METHODS: Patients attended to the outpatient clinic of physical medicine and rehabilitation department with a diagnosis of focal spasticity and had BTX-A injections because of spasticty were evaluated for the study. Demographic data, exercise status, orthoses, drugs used for spasticity, functional status, stages of spasticity of muscles before and after 1st and 3rd months of BTX-A injection according to Modified Ashworth Scale (MAS) were evaluated retrospectively. MedCalc 11.6 statistical program was used for statistical analyses. Statistical significance was defined as p<0.05. RESULTS: Forty-nine patients with focal spasticity were recruited for the study (35 men, 14 women). Mean age of the patients was 21.59±20.09 years. The patients had cerebral palsy (CP, n=28), 19 had hemiplegia (n=19) and paraplegia (n=2). Forty-three patients were using orthoses and exercising regularly. Mean Pediatric Functional Independence Measurement (WeeFIM) scores of the patients with CP was 54.82±28.91 and according to the Gross Motor Function Classification System (GMFCS) the patients were in stages 2 (14%), 3 (46%), 4 (11%) and 5 (29%). Mean Functional Independence Measure (FIM) of hemiplegic and paraplegic patients was 80.80±20.88. Brunnstrom staging scores for upper extremity (3.52±0.96), hands (2.68±0.82), lower extremity (4.57±1.01) were calculated. MAS muscles demonstrated statistically significant decrease in spasticity at the end of first and third months (p<0.05). CONCLUSION: We saw a significant decrease in the spasticity of upper and lower extremities in patients with focal spasiticity who received BTX-A injections. We suggest that if BTX-A injections are supported with orthoses and exercise programs, then functional status of the patients would be better.
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Pimentel LHC, Alencar FJ, Rodrigues LRS, Sousa FCFD, Teles JBM. Effects of botulinum toxin type A for spastic foot in post-stroke patients enrolled in a rehabilitation program. ARQUIVOS DE NEURO-PSIQUIATRIA 2014; 72:28-32. [PMID: 24637979 DOI: 10.1590/0004-282x20130189] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/22/2013] [Accepted: 09/19/2013] [Indexed: 11/22/2022]
Abstract
UNLABELLED The objective of this study was to evaluate the effects of botulinum toxin type A (BTX-A) on spastic foot in stroke patients in a rehabilitation program. METHOD Hemiparetic stroke patients (n=21) enrolled in a rehabilitation program were divided into two groups. The first group (n=11) received a total of 300 UI BTX-A, and the second group (n=10) received 100 UI BTX-A. All patients were assessed at baseline and 2, 4, 8 and 12 weeks after injection for Modified Ashworth Score, time walking 10 meters, and the Functional Independence Measure (mFIM) motor score. RESULTS The higher-dose group exhibited a significant improvement in spasticity, and both groups showed an improvement in time walking 10 meters and mFIM, with no significant differences between them. CONCLUSIONS Our findings suggest that gains in gait velocity and functional independence were not correlated to BTX-A dose.
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Bensmail D, Hanschmann A, Wissel J. Satisfaction with botulinum toxin treatment in post-stroke spasticity: results from two cross-sectional surveys (patients and physicians). J Med Econ 2014; 17:618-25. [PMID: 24841450 DOI: 10.3111/13696998.2014.925462] [Citation(s) in RCA: 38] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
OBJECTIVE To characterize patient and physician satisfaction with current standard-of-care botulinum toxin treatment regimens for symptom control in patients with post-stroke spasticity using structured interviews with patients and physicians. RESEARCH DESIGN AND METHODS Two cross-sectional surveys were conducted in Canada, France, Germany, and the US. The patient survey included patients with post-stroke spasticity who had undergone at least two botulinum toxin A injection cycles. Information on patients' current and prior botulinum toxin treatment cycles and quality of life was collected. The physician survey included physicians treating post-stroke spasticity with botulinum toxins and collected information regarding physician satisfaction with botulinum toxin treatment for post-stroke spasticity. RESULTS Of 79 participating patients with post-stroke spasticity, 61 (77%) received treatment with onabotulinumtoxinA, 15 (19%) with abobotulinumtoxinA, and three (4%) with incobotulinumtoxinA. Overall, 40.5% of patients were very satisfied, 48.1% were somewhat satisfied, and 11.4% were not at all satisfied with botulinum toxin treatment. Patient satisfaction was lowest just before injection and highest at the time of peak effect. The mean injection interval was 13.7 (SD = 3.5) weeks; however, 43.4% of patients expressed a preference for intervals of ≤ 10 weeks. Most of the 105 participating physicians' were moderately (57.7%) or very (36.5%) satisfied with botulinum toxin treatment. However, physicians estimated that 16.2% of their patients with post-stroke spasticity could benefit from shorter injection intervals, and that 24.6% of patients could benefit from higher doses than those permitted by current country directives. STUDY LIMITATIONS Patients' responses were based on subjective recollections and physicians' responses were based on general impressions. CONCLUSIONS These surveys indicate that patients' and physicians' satisfaction with botulinum toxin therapy for post-stroke spasticity is overall very good. However, patients' satisfaction over the treatment cycle varied with onset, peak, and trough of treatment effects and patients and physicians expressed a need for treatment individualization.
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Affiliation(s)
- Djamel Bensmail
- Hôpital Raymond-Poincaré (AP-HP), Université de Versailles Saint Quentin , Garches , France
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Thanakiatpinyo T, Suwannatrai S, Suwannatrai U, Khumkaew P, Wiwattamongkol D, Vannabhum M, Pianmanakit S, Kuptniratsaikul V. The efficacy of traditional Thai massage in decreasing spasticity in elderly stroke patients. Clin Interv Aging 2014; 9:1311-1319. [PMID: 25143717 PMCID: PMC4136956 DOI: 10.2147/cia.s66416] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
PURPOSE To study the efficacy of traditional Thai massage (TTM) versus conventional physical therapy (PT) programs in treating muscle spasticity, functional ability, anxiety, depression, and quality of life (QoL) in Thai stroke patients. METHODS This randomized controlled trial with a blinded assessor was carried out at the Department of Rehabilitation Medicine, Siriraj Hospital (Bangkok, Thailand). The study included 50 stroke (onset ≥ 3 months) outpatients experiencing spasticity at the elbow or knee muscles at a grade of ≥ 1+ on the modified Ashworth Scale who were ≥ 50 years old and able to communicate. The subjects were randomly allocated to the treatment group receiving TTM (24 subjects) or the control group receiving the PT program (26 subjects). Both groups received treatment (either TTM or PT) twice a week for 6 weeks. Spasticity grade, functional ability, anxiety, depression, and QoL were measured at Week 0 and Week 6. RESULTS At Week 6, the percentage of patients whose modified Ashworth Scale score had decreased by at least one grade was not statistically significant between the two groups. Both TTM and PT groups experienced a significant increase in functional ability and QoL, but no difference was found between the groups. Anxiety and depression scores showed a decreasing trend in the TTM group. CONCLUSION This preliminary report showed no evidence that TTM differed from the PT program in decreasing spasticity. However, both interventions may relieve spasticity, increase functional ability, and improve QoL after 6 weeks. Only TTM can decrease anxiety and depression scores. Further studies with adequate sample size are necessary.
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Affiliation(s)
| | - Supakij Suwannatrai
- Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Ueamphon Suwannatrai
- Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Phanitanong Khumkaew
- Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Dokmai Wiwattamongkol
- Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Manmas Vannabhum
- Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | - Somluck Pianmanakit
- Department of Rehabilitation Medicine, Mahidol University, Bangkok, Thailand
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Otom AH, Al-Khawaja IM, Al-Quliti KW. Botulinum toxin type-A in the management of spastic equinovarus deformity after stroke. Comparison of 2 injection techniques. NEUROSCIENCES (RIYADH, SAUDI ARABIA) 2014; 19:199-202. [PMID: 24983281 PMCID: PMC4727653] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 02/05/2014] [Accepted: 05/06/2014] [Indexed: 11/17/2022]
Abstract
OBJECTIVE To retrospectively compare 2 injection techniques in the management of spastic equinovarus deformity after stroke. METHODS Patients with stroke were seen at King Hussein Medical Center, Amman, Jordan between January and December 2009. The study design involved an open label retrospective analysis of medical records of 2 groups of comparable age and onset of first stroke. Botulinum toxin was injected into the calf muscles at 2 sites in group I (12 patients) and 4 sites in group II (14 patients). Functional gain was evaluated by the time to walk 10 meters at month one, 3, and 6 compared with baseline. RESULTS There was significant improvement in walking time in each study group. However, there was no significant difference between the 2 groups as measured by the 10-meter walking time. CONCLUSION Fewer injection sites would minimize patient discomfort and possibly the production of antibodies, yielding similar therapeutic effects.
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Affiliation(s)
- Ali H. Otom
- From the Department of Rehabilitation Medicine, Royal Jordanian Rehabilitation Center (Otom), King Hussain Medical City, Amman, Jordan, and the Department of Medicine, Faculty of Medicine (Al-Khawaja, Al-Quliti), Taibah University, Al-Madinah Al-Monawwarah, Kingdom of Saudi Arabia
| | - Imad M. Al-Khawaja
- From the Department of Rehabilitation Medicine, Royal Jordanian Rehabilitation Center (Otom), King Hussain Medical City, Amman, Jordan, and the Department of Medicine, Faculty of Medicine (Al-Khawaja, Al-Quliti), Taibah University, Al-Madinah Al-Monawwarah, Kingdom of Saudi Arabia
| | - Khalid W. Al-Quliti
- From the Department of Rehabilitation Medicine, Royal Jordanian Rehabilitation Center (Otom), King Hussain Medical City, Amman, Jordan, and the Department of Medicine, Faculty of Medicine (Al-Khawaja, Al-Quliti), Taibah University, Al-Madinah Al-Monawwarah, Kingdom of Saudi Arabia
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Picelli A, Tamburin S, Cavazza S, Scampoli C, Manca M, Cosma M, Berto G, Vallies G, Roncari L, Melotti C, Santilli V, Smania N. Relationship between ultrasonographic, electromyographic, and clinical parameters in adult stroke patients with spastic equinus: an observational study. Arch Phys Med Rehabil 2014; 95:1564-70. [PMID: 24792138 DOI: 10.1016/j.apmr.2014.04.011] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2014] [Revised: 04/10/2014] [Accepted: 04/12/2014] [Indexed: 11/19/2022]
Abstract
OBJECTIVE To find more accurate indices that could affect decisions in spasticity treatment by investigating the relation between ultrasonographic, electromyographic, and clinical parameters of the gastrocnemius muscle in adults with spastic equinus after stroke. DESIGN Observational study. SETTING University hospitals. PARTICIPANTS Chronic patients with stroke with spastic equinus (N=43). INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Ultrasonographic features were spastic gastrocnemius muscle echo intensity, muscle thickness, and posterior pennation angle of the gastrocnemius medialis (GM) and gastrocnemius lateralis (GL) in both legs. Electromyographic evaluation included compound muscle action potentials (CMAPs) recorded from the GM and GL of both legs. Clinical assessment of the spastic gastrocnemius muscle was performed with the Modified Ashworth Scale (MAS) and by measuring ankle dorsiflexion passive range of motion (PROM). RESULTS Spastic muscle echo intensity was inversely associated with proximal (GM and GL: P=.002) and distal (GM and GL: P=.001) muscle thickness, pennation angle (GM: P< .001; GL: P=.01), CMAP (GM: P=.014; GL: P=.026), and ankle PROM (GM: P=.038; GL: P=.024). The pennation angle was directly associated with the proximal (GM and GL: P< .001) and distal (GM: P=.001; GL: P< .001) muscle thickness of the spastic gastrocnemius muscle. The MAS score was directly associated with muscle echo intensity (GM: P=.039; GL: P=.027) and inversely related to the pennation angle (GM and GL: P=.001) and proximal (GM: P=.016; GL: P=.009) and distal (GL: P=.006) muscle thickness of the spastic gastrocnemius. CONCLUSIONS Increased spastic muscle echo intensity was associated with reduced muscle thickness, posterior pennation angle, and CMAP amplitude in the gastrocnemius muscle. Building on previous evidence that these instrumental features are related to botulinum toxin response, these new findings may usefully inform spasticity treatment decisions.
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Affiliation(s)
- Alessandro Picelli
- Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy
| | - Stefano Tamburin
- Neurology Section, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy
| | | | | | - Mario Manca
- Motion Analysis Laboratory, San Giorgio Hospital, Ferrara, Italy
| | - Michela Cosma
- Motion Analysis Laboratory, San Giorgio Hospital, Ferrara, Italy
| | - Giulia Berto
- Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy
| | - Gabriella Vallies
- Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy
| | - Laura Roncari
- Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy
| | - Camilla Melotti
- Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy
| | - Valter Santilli
- Physical Medicine and Rehabilitation, Department of Orthopedic Science, Sapienza University of Rome, Rome, Italy
| | - Nicola Smania
- Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurological and Movement Sciences, University of Verona, Verona, Italy; Neurological Rehabilitation Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
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Isoyama H, Takeuchi N. Overview of botulinum toxin as a treatment for spasticity in stroke patients. World J Neurol 2013; 3:133-137. [DOI: 10.5316/wjn.v3.i4.133] [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: 06/26/2013] [Revised: 10/03/2013] [Accepted: 11/05/2013] [Indexed: 02/06/2023] Open
Abstract
Spasticity after the occurrence of stroke induces limb deformity, functional disability and/or pain in patients, which limits their activities of daily living and deteriorates their quality of life. Botulinum toxin (BTX) has recently been reported as an efficacious therapeutic agent for the treatment of spasticity. Systematic review and meta-analysis studies have demonstrated that BTX therapy after stroke reduces spasticity and increases physical activity capacity and performance levels. Moreover, BTX can be used as an adjuvant in physiotherapy. Several studies have confirmed that the combination of BTX therapy and physiotherapy improves motor recovery. However, to date, only a few such combination studies have been conducted and their findings are considered preliminary and controversial. Therefore, future studies are required to determine the appropriate combination of treatment methods that will aid motor recovery.
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Ockrim Z, Weir CR, Li Yim J, Cleary M. Botulinum toxin as a postoperative diplopia test - it can also reduce the angle of deviation prior to surgery. Strabismus 2013; 21:199-202. [PMID: 24171866 DOI: 10.3109/09273972.2013.833951] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
PURPOSE To investigate how frequently botulinum toxin, when used as a postoperative diplopia test, reduces the angle of deviation prior to subsequent strabismus surgery. METHODS A retrospective study of 39 adult patients with constant concomitant horizontal strabismus who had undergone botulinum toxin injections to assess the risk of postoperative diplopia and then subsequently underwent strabismus surgery. RESULTS Fourteen out of 39 patients (36%) sustained a reduction of 15 prism diopters or more for near and/or distance when comparing the pre-injection angle of deviation with the preoperative angle of deviation. CONCLUSION Approximately one-third of patients receiving botulinum toxin as a postoperative diplopia test maintained a significant reduction in the angle of their deviation prior to undergoing surgery.
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Affiliation(s)
- Zoe Ockrim
- Tennent Institute of Ophthalmology, Gartnavel General Hospital Glasgow , UK
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Abstract
Antispastic medications that are directed to reduce clinical signs of spasticity, such as exaggerated reflexes and muscle tone, do not improve the movement disorder. Medication can even increase weakness which might interfere with functional movements, such as walking. In this chapter we address how spasticity affects mobility and how this should be taken into account in the treatment of spasticity. In clinical practice, signs of exaggerated tendon tap reflexes associated with muscle hypertonia are the consequence of spinal cord injury (SCI). They are generally thought to be responsible for spastic movement disorders. Most antispastic treatments are, therefore, directed at the reduction of reflex activity. In recent years, a discrepancy between spasticity as measured in the clinic and functional spastic movement disorder was noticed, which is primarily due to the different roles of reflexes in passive and active states, respectively. We now know that central motor lesions are associated with loss of supraspinal drive and defective use of afferent input with impaired behavior of short-latency and long-latency reflexes. These changes lead to paresis and maladaptation of the movement pattern. Secondary changes in mechanical muscle fiber, collagen tissue, and tendon properties (e.g., loss of sarcomeres, subclinical contractures) result in spastic muscle tone, which in part compensates for paresis and allows functional movements on a simpler level of organization. Antispastic drugs should primarily be applied in complete SCI. In mobile patients they can accentuate paresis and therefore should be applied with caution.
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Affiliation(s)
- Volker Dietz
- Balgrist University Hospital, Zurich, Switzerland.
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Kim WJ, Kumthornthip W, Oh BM, Yang EJ, Paik NJ. Feasibility of video clip analysis on effect of botulinum toxin-A injection for post-stroke upper limb spasticity. Toxins (Basel) 2013; 5:983-91. [PMID: 23666198 PMCID: PMC3709274 DOI: 10.3390/toxins5050983] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/06/2013] [Revised: 03/25/2013] [Accepted: 04/24/2013] [Indexed: 11/16/2022] Open
Abstract
Existing functional evaluation tools do not accurately reveal the improved function following botulinum toxin A (BTX-A) injection for post-stroke upper limb spasticity. With the aim of developing an alternate method of measuring functional improvement following BTX-A injection, this study tested the feasibility, validity and reliability of video clip analysis performed by the clinicians. Seventy-nine patients administered BTX-A due to post-stroke upper limb spasticity, were retrospectively evaluated using video clip analysis. Pre- and post-injection video clips recorded at 1-month intervals were randomly allocated and sent to three blinded physician evaluators who were asked to choose the one that seemed more improved in terms of hand motion and associated upper limb reaction during gait. The three physicians chose the post-injection video clip as depicting improved hand motion (82.3%, 79.7%, and 72.2%) and associated upper limb reaction during gait (73.4%, 70.9%, and 70.9%). Kappa and intraclass correlation coefficient as a measure of interrater reliability among the three physicians was 0.86 and 0.79 for the hand, and 0.92 and 0.92 for associated upper limb reaction during gait, respectively. The percent overall agreement of the physicians was 78.1% and 71.7% for hand function and associated upper limb reaction, respectively. Retrospective pre- and post-BTX-A injection video clip analyses is a clinically feasible alternative method to evaluate the improvement following BTX-A injection for post-stroke upper limb spasticity, especially in busy clinical practice setting.
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Affiliation(s)
- Woo-Jin Kim
- Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea; E-Mails: (W.-J.K.); (E.J.Y.)
- Department of Physical Medicine and Rehabilitation, Haeundae Paik Hospital, Inje University of Medicine, Busan 612-896, South Korea
| | - Witsanu Kumthornthip
- Department of Rehabilitation Medicine, Siriraj Hospital, Mahidol University, Bankok 73170, Thailand; E-Mail:
| | - Byung Mo Oh
- Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul 110-744, South Korea; E-Mail:
| | - Eun Joo Yang
- Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea; E-Mails: (W.-J.K.); (E.J.Y.)
| | - Nam-Jong Paik
- Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seongnam 463-707, South Korea; E-Mails: (W.-J.K.); (E.J.Y.)
- Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul 110-799, South Korea
- Author to whom correspondence should be addressed; E-Mail: ; Tel.: +82-31-787-7731; Fax: +82-31-712-3913
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Ghasemi M, Salari M, Khorvash F, Shaygannejad V. A literature review on the efficacy and safety of botulinum toxin: an injection in post-stroke spasticity. Int J Prev Med 2013; 4:S147-58. [PMID: 23776717 PMCID: PMC3678211] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2012] [Accepted: 02/23/2013] [Indexed: 11/06/2022] Open
Abstract
BACKGROUND A variety of techniques for the management of spasticity have been suggested, including positioning, cryotherapy, splinting and casting, biofeedback, electrical stimulation, and medical management by pharmacological agents, Botulinum toxin A (BTA) is now the pharmacological treatment of choice in focal spasticity. BTA by blocking acetylcholine release at neuromuscular junctions accounts for its therapeutic action to relieve spasticity. METHODS A computerized search of Pub Med was carried out to find the latest result about efficacy of BTA in management of post stroke spasticity. RESULT Among 84 articles were found, frothy of them included in this review and divided to lower and upper extremity. CONCLUSIONS BTA is a treatment choice in reducing tone and managing post stroke spasticity .
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Affiliation(s)
- Majid Ghasemi
- Department of Neurology, Isfahan Neurosciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Mehri Salari
- Department of Neurology, Isfahan Neurosciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Fariborz Khorvash
- Department of Neurology, Isfahan Neurosciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Vahid Shaygannejad
- Department of Neurology, Isfahan Neurosciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
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Chan J, Winter A, Palit M, Sturt R, Graaff SD, Holland AE. Are gait and mobility measures responsive to change following botulinum toxin injections in adults with lower limb spasticity? Disabil Rehabil 2012; 35:959-67. [PMID: 23025332 DOI: 10.3109/09638288.2012.717579] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
PURPOSE To determine whether gait and mobility measures are responsive to change following botulinum toxin (BoNT) injections in adults with lower limb spasticity. METHOD Independently ambulant adults who attended a spasticity clinic for lower limb BoNT injections were eligible to participate. The 10 m walk test (shoes on and off), timed up and go test and 6-min walk test were performed before injection and 1 month later. Participants completed a global rating of change scale (GRCS) at follow up. Comparisons were made between participants' ratings of change and change in walking performance. Effect sizes (ES) and standard error of measurement (SEM) were calculated for each outcome. RESULTS Thirty-nine patients (22 female, 17 male; mean age 51 ± 12 years; range 26-74 years) with a median spasticity duration of 53 months participated. Statistically significant changes were found in all gait and mobility measures at 1 month following injection. All ES were small (<0.2) and SEM for each measure was large. The global rating of change scale (GRCS) indicated that 66% of participants perceived that their walking had improved. However, there was a significant relationship between GRCS and performance on walking tests for the 10 m walk test with shoes off (p = 0.01) and timed up and go test (p = 0.02) only. CONCLUSION Commonly used walking tests may not be responsive to change following BoNT injection. The small ES suggest that BoNT has a modest effect on walking ability. Tests of walking performance may not be sufficient to capture all clinically relevant changes in walking ability following BoNT injection of the lower limb.
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Affiliation(s)
- Joyce Chan
- School of Physiotherapy, La Trobe University, Bundoora 3068, Australia
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Tang SF, Hong JP, McKay WB, Tang CW, Wu PH, Chu NK. Modification of altered ankle motor control after stroke using focal application of Botulinum toxin type A. Clin Neurol Neurosurg 2012; 114:498-501. [DOI: 10.1016/j.clineuro.2012.03.014] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2012] [Accepted: 03/02/2012] [Indexed: 11/26/2022]
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Rosales RL, Kong KH, Goh KJ, Kumthornthip W, Mok VCT, Delgado-De Los Santos MM, Chua KSG, Abdullah SJBF, Zakine B, Maisonobe P, Magis A, Wong KSL. Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: a randomized controlled trial. Neurorehabil Neural Repair 2012; 26:812-21. [PMID: 22371239 DOI: 10.1177/1545968311430824] [Citation(s) in RCA: 83] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
Abstract
BACKGROUND Botulinum neurotoxin type A (BoNT-A) reduces upper-extremity poststroke spasticity when given 6 or more months after stroke. Effects on functional use of the arm and hand are less apparent. OBJECTIVE To determine the effect and safety of very early use of BoNT-A for patients with upper-limb spasticity. METHODS The Asia Botulinum Toxin-A Clinical Trial DESIGN ed for Early Post-stroke Spasticity (ABCDE-S; NCT00234546) was a multicenter, randomized, placebo-controlled trial conducted in patients recruited within 2 -12 weeks of first-ever stroke. Participants with a Modified Ashworth Scale (MAS) score of 1+ or above received BoNT-A (Dysport) 500 U or placebo to one or more wrist and elbow mover muscles, plus unstructured rehabilitation. The primary outcome was the MAS score in the most affected joint 4 weeks after first injection. Follow-up was 24 weeks. RESULTS A total of 163 patients were enrolled and assigned to placebo (n = 83) or BoNT-A (n = 80). Mean time since stroke was about 7 weeks. At 4 weeks postinjection, BoNT-A significantly improved MAS scores. Treatment effect-size estimates increased with higher baseline MAS scores from 0.45 (Q1) to 0.70 (Q3). MAS scores for all secondary end points improved with BoNT-A versus placebo at all time points (P < .0001, all visits). The Functional Motor Assessment Scale did not reveal clinically significant differences. No group differences in adverse events were found. Interpretation. BoNT-A 500 U can provide a sustained reduction in poststroke upper-limb spasticity when combined with rehabilitation in Asian patients who have mild-to-moderate hypertonicity and voluntary movement, within 2 -12 weeks of stroke. Functional use of the arm and hand was not affected.
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Therapeutic use of botulinum toxin in neurorehabilitation. J Toxicol 2011; 2012:802893. [PMID: 21941544 PMCID: PMC3172973 DOI: 10.1155/2012/802893] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/05/2011] [Revised: 06/28/2011] [Accepted: 07/13/2011] [Indexed: 12/14/2022] Open
Abstract
The botulinum toxins (BTX), type A and type B by blocking vesicle acetylcholine release at neuro-muscular and neuro-secretory junctions can result efficacious therapeutic agents for the treatment of numerous disorders in patients requiring neuro-rehabilitative intervention. Its use for the reduction of focal spasticity following stroke, brain injury, and cerebral palsy is provided. Although the reduction of spasticity is widely demonstrated with BTX type A injection, its impact on the improvement of dexterity and functional outcome remains controversial. The use of BTX for the rehabilitation of children with obstetrical brachial plexus palsy and in treating sialorrhea which can complicate the course of some severe neurological diseases such as amyotrophic lateral sclerosis and Parkinson's disease is also addressed. Adverse events and neutralizing antibodies formation after repeated BTX injections can occur. Since impaired neurological persons can have complex disabling feature, BTX treatment should be viewed as adjunct measure to other rehabilitative strategies that are based on the individual's residual ability and competence and targeted to achieve the best functional recovery. BTX therapy has high cost and transient effect, but its benefits outweigh these disadvantages. Future studies must clarify if this agent alone or adjunctive to other rehabilitative procedures works best on functional outcome.
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Teles MS, Mello EMCDL. Toxina botulínica e fisioterapia em crianças com paralisia cerebral espástica: revisão bibliográfica. FISIOTERAPIA EM MOVIMENTO 2011. [DOI: 10.1590/s0103-51502011000100021] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
INTRODUÇÃO: A paralisia cerebral (PC) é definida como uma condição neurológica não progressiva originada em razão de uma lesão no encéfalo imaturo que compromete os movimentos e a postura. A espasticidade está presente em 75% dos casos. Essa patologia tem incidência na população de aproximadamente 2 em cada 1.000 nascidos vivos e pode chegar a até 7 por 1.000 em países em desenvolvimento. O objetivo do estudo foi realizar uma revisão bibliográfica por meio da seleção e análise criteriosa de artigos científicos que relatem os efeitos da aplicação da toxina botulínica tipo A associada à fisioterapia em crianças com paralisia cerebral espástica. MATERIAIS E MÉTODOS: Foi realizada uma revisão bibliográfica nas bases de dados eletrônicas MEDLINE, LILACS e SciELO, no período de 1997 a 2009. Os descritores utilizados foram: "paralisia cerebral" e "espasticidade muscular", combinados com "toxina botulínica tipo A" e "fisioterapia". RESULTADOS: Somando-se todos os bancos de dados, um total de 50 artigos que continham os desfechos de interesse dessa revisão foram encontrados, no entanto, alguns artigos aparecem em mais de uma busca e em duplicidade de idioma. Então, 23 artigos foram utilizados neste estudo. DISCUSSÃO: Vários estudos demonstram que, para maior efetividade da toxina botulínica tipo A, esta deve ser associada a um programa fisioterapêutico que sempre deve considerar as etapas do desenvolvimento motor da criança. CONSIDERAÇÕES FINAIS: De acordo com a revisão bibliográfica apresentada, a TBA associada à fisioterapia para o controle da espasticidade se mostra bastante eficaz. Contudo, novas pesquisas acerca deste assunto são necessárias.
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Efficacy and safety of botulinum neurotoxin NT 201 in poststroke upper limb spasticity. Clin Neuropharmacol 2010; 32:259-65. [PMID: 19644361 DOI: 10.1097/wnf.0b013e3181b13308] [Citation(s) in RCA: 78] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE To assess the impact of the new botulinum neurotoxin type A preparation NT 201 (Xeomin; Merz Pharmaceuticals GmbH, Frankfurt, Germany) on muscle tone, functional disability, and caregiver burden in patients with poststroke upper limb spasticity in a randomized, placebo-controlled, double-blind study. METHODS One hundred forty-eight patients with an Ashworth Scale score of 2 or higher for wrist and finger flexors and at least moderate disability in their principal therapeutic target of the Disability Assessment Scale were treated either with NT 201 (median, 320 U) or placebo and followed up for up to 20 weeks. Treatment of the wrist and finger muscles was mandatory. RESULTS A significantly higher proportion of patients treated with NT 201 were responders (improvement of > or =1 point in the Ashworth Scale score), as observed in comparison to placebo 4 weeks after treatment in wrist flexors (odds ratio, 3.97; 95% confidence interval, 1.9-8.3; P < 0.001, intent to treat). For all treated flexor muscle groups, statistically significant odds ratios in favor of NT 201 were observed at week 4 (P < or = 0.009). Statistically significant results in favor of NT 201 were observed at all postinjection visits until week 12 in the principal therapeutic target (P < or = 0.005), in the global assessment of efficacy (P < 0.001), and in some tasks of the Carer Burden Scale (P < 0.05). Similar numbers of patients in each group experienced at least 1 adverse event (NT 201, n = 21; placebo, n = 20). Importantly, none of the patients developed neutralizing antibodies. CONCLUSIONS NT 201 led to statistically significant improvements in muscle tone and disability and was well tolerated in patients with poststroke upper limb spasticity.
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Botulinum toxin type A injection in alleviating postoperative pain and improving quality of life in lower extremity limb lengthening and deformity correction: a pilot study. J Pediatr Orthop 2009; 29:427-34. [PMID: 19568011 DOI: 10.1097/bpo.0b013e3181aad628] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND The Ilizarov technique is commonly used for lengthening and deformity corrections of the lower limbs in children. Postoperative pain can be significant, affecting quality of life and functional mobility, and often requiring prolonged medication use. Several studies have investigated the antinociceptive actions of botulinum toxin type A (BtX-A), yet evidence for its use in this population is limited. The objectives were to (1) establish the feasibility of a randomized clinical trial in children undergoing limb lengthening or deformity correction and (2) provide preliminary evidence of the beneficial effects of BtX-A in this population. METHODS Fifty-two patients with a mean age of 13.7 years (range, 5 to 21 y) were randomized to receive either BtX-A or an equivalent volume of sterile saline solution (placebo group), as a single dose during the surgical procedure. Pain, medication use, quality of life, and functional mobility outcomes were assessed in all patients. Adverse events were reported for all patients and classified as minor or major. RESULTS Differences between groups did not reach statistical significance; however, pain at mid-distraction was found to be slightly lower in the BtX-A group, as compared with the placebo group. Patients in the BtX-A group used less parenteral pain medication in the first 4 days after the surgery, had higher quality of life scores at 3 of the 5 time points assessed, and slightly higher functional mobility scores. All adverse events were expected complications of the lengthening process. No event was considered to be a serious adverse event related to the BtX-A injection itself. There was a trend toward fewer major adverse events in the BtX-A group. CONCLUSIONS This pilot study established the feasibility of a randomized controlled trial design for in this population. Its findings indicate that BtX-A injections appear to be safe and effective for reducing pain and improving the quality of life and functional mobility of children undergoing lengthening or deformity corrections of the lower limbs. A larger-scale study is currently underway to confirm these preliminary findings.
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Elovic EP, Esquenazi A, Alter KE, Lin JL, Alfaro A, Kaelin DL. Chemodenervation and Nerve Blocks in the Diagnosis and Management of Spasticity and Muscle Overactivity. PM R 2009; 1:842-51. [DOI: 10.1016/j.pmrj.2009.08.001] [Citation(s) in RCA: 45] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2009] [Accepted: 08/06/2009] [Indexed: 01/04/2023]
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Abstract
Recent evidence indicates that the brain can remodel after stroke, primarily through synaptogenesis. Task-specific and repetitive exercise appear to be key factors in promoting synaptogenesis and are central elements in rehabilitation of motor weakness following stroke. Expert medical management ensures a patient is well enough to participate in rehabilitation with minimal distractions due to pain or depression. Contraint-induced motor therapy and body-weight-supported ambulation are forms of exercise that "force use" of an impaired upper extremity. Technologies now in common use include robotics, functional electrical stimulation, and, to a lesser degree, transcranial magnetic stimulation and virtual reality. The data on pharmacological interventions are mixed but encouraging; it is hoped such treatments will directly stimulate brain tissue to recovery. Mitigation of factors preventing movement, such as spasticity, might also play a role. Research evaluating these motor recovery strategies finds them generally good at the movement level but somewhat less robust when looking at functional performance. It remains unclear whether inconsistent evidence for functional improvement is a matter of poor treatment efficacy or insensitive outcome measures.
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Affiliation(s)
- Michael W O'Dell
- Department of Rehabilitation Medicine, New York-Presbyterian Hospital, Weill Cornell Medical Center, New York, New York 10021, USA.
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Mohammadi B, Balouch SA, Dengler R, Kollewe K. Long-term treatment of spasticity with botulinum toxin type A: an analysis of 1221 treatments in 137 patients. Neurol Res 2009; 32:309-13. [PMID: 19726016 DOI: 10.1179/016164109x12478302362734] [Citation(s) in RCA: 29] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/31/2022]
Abstract
OBJECTIVES Spasticity is a complex disorder that causes significant disability in affected patients. We here present long-term results of botulinum toxin type A (BoNT-A) treatment in spasticity of various etiologies in the upper and lower limbs. PATIENTS AND METHODS We evaluated long-term results of BoNT-A treatment with Dysport and Botox for up to 12 years in 137 patients with spasticity of various etiologies. The focus was laid on efficacy, dosage, safety and side effects over time in a retrospective analysis of the database of our movement disorder clinic. RESULTS The mean clinical benefit, latency and duration of response were comparable for both products. Side effects were generally mild and comparable for the two products. We found a significant negative correlation between time from onset of spasticity to start of BoNT-A treatment and degree of improvement after treatment. CONCLUSION Our data confirm the safety and efficacy of BoNT-A treatment of spasticity of different etiologies over a long period of time. Furthermore, the data imply that BoNT-A treatment should be started early after appearance of spasticity to obtain better treatment response.
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Affiliation(s)
- B Mohammadi
- Department of Neurology and Clinical Neurophysiology, Medical School Hannover, Hannover, Germany.
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