|
1
|
Ishii T, Kawaguchi Y, Ishikawa O, Takemori H, Takasawa N, Kobayashi H, Takahashi Y, Yasuoka H, Kodera T, Takai O, Nakaya I, Sato Y, Izumiyama T, Fujii H, Kamogawa Y, Shirota Y, Shirai T, Fujita Y, Saito S, Chiu SW, Yamaguchi T, Shimokawa H, Harigae H. Effectiveness and safety of low-energy shock wave therapy for digital ulcers associated with systemic sclerosis: A Phase 3 pivotal clinical trial. Mod Rheumatol 2025; 35:484-495. [PMID: 39562303 DOI: 10.1093/mr/roae104] [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: 04/09/2024] [Revised: 06/30/2024] [Accepted: 11/04/2024] [Indexed: 11/21/2024]
Abstract
OBJECTIVES Systemic sclerosis (SSc) is characterised by ischaemic skin ulcers on the fingertips, and low-energy shock wave therapy is suggested as a novel treatment for ischaemic lesions with angiogenic effects. We aimed to investigate the efficacy and safety of shock wave therapy for skin ulcers in patients with SSc. METHODS In this Phase 3 pivotal study, we analysed 60 SSc patients with digital ulcers that did not disappear after >4 weeks of existing treatment: 30 patients were treated with extracorporeal shock wave therapy and 30 with conventional treatment. The ulcer count reduction observed after an 8-week treatment period was compared between the shock wave therapy and conventional treatment groups. RESULTS After an 8-week treatment period, the mean reduction in the number of ulcers was 0.83 (SD 2.79) in the conventional treatment group compared to a more pronounced reduction of 4.47 (SD 2.65) in the shock wave therapy group. CONCLUSIONS The study findings indicate the efficacy of extracorporeal shock wave therapy for refractory digital ulcers associated with SSc, which has limited therapeutic options. This therapy is non-invasive and safe and can be used without restriction in combination with other therapies, thus serving as a novel therapeutic method.
Collapse
Affiliation(s)
- Tomonori Ishii
- Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Miyagi, Japan
- Division of Hematology and Rheumatology, Tohoku Medical and Pharmaceutical University, Sendai, Miyagi, Japan
| | - Yasushi Kawaguchi
- Division of Rheumatology, Department of Internal Medicine, Tokyo Women's Medical University, Tokyo, Japan
| | - Osamu Ishikawa
- Department of Dermatology, Gunma University Graduate School of Medicine, Gunma, Japan
| | | | - Naruhiko Takasawa
- Department of Rheumatology, Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai, Japan
| | - Hitoshi Kobayashi
- Suginoko-kai Marios Kobayashi Internal Medicine Clinic, Iwate, Japan
| | | | - Hidekata Yasuoka
- Division of Rheumatology, Department of Internal Medicine, Fujita Health University School of Medicine, Aichi, Japan
| | - Takao Kodera
- Division of Hematology and Rheumatology, Tohoku Medical and Pharmaceutical University, Sendai, Miyagi, Japan
| | | | - Izaya Nakaya
- Department of Nephrology and Rheumatology, Iwate Prefectural Central Hospital, Morioka, Iwate, Japan
| | - Yukio Sato
- Kaiyama Central Hospital, Sendai, Miyagi, Japan
| | | | - Hiroshi Fujii
- Department of Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
| | - Yukiko Kamogawa
- Ichibancho Internal Medicine & Rheumatology Clinic, Sendai, Miyagi, Japan
| | - Yuko Shirota
- Department of Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
| | - Tsuyoshi Shirai
- Department of Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
| | - Yoko Fujita
- Kouzenkai (Kouzen Association), Sakuragaoka Aozora Internal Medicine Clinic, Miyagi, Japan
| | | | - Shih-Wei Chiu
- Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
| | - Takuhiro Yamaguchi
- Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
| | - Hiroaki Shimokawa
- Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
| | - Hideo Harigae
- Department of Hematology, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan
| |
Collapse
|
|
2
|
Dymarek R, Kuberka I, Walewicz K, Taradaj J, Rosińczuk J, Sopel M. Is Shock Wave Application Effective on Various Chronic Wounds in the Geriatric Population? Preliminary Clinical Study. Clin Interv Aging 2024; 19:665-679. [PMID: 38706636 PMCID: PMC11069372 DOI: 10.2147/cia.s448298] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2023] [Accepted: 04/01/2024] [Indexed: 05/07/2024] Open
Abstract
Purpose Extracorporeal shock wave therapy (ESWT) is a beneficial adjunct modality for chronic wounds. Limited research has been conducted on pressure ulcers (PUs), while the majority of studies have focused on diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This study aimed to evaluate the short-term effects of radial ESWT in older adults with chronic wounds. Patients and Methods This study involved a total of 31 wounds: PUs (n=22), VLUs (n=7), and DFUs (n=2). A single radial ESWT was performed with 300 + 100 shocks per cm2, pressure of 2.5 bar, energy of 0.15 mJ/mm2, and frequency of 5 Hz. Assessments using digital planimetry and clinical methods, utilizing the Wound Bed Score (WBS) and the Bates-Jansen Wound Assessment Tool (BWAT) were performed before the radial ESWT application (M0) and one week after (M1). Results A significant wound decrease in planimetry was noted (pre-ESWT vs post-ESWT), with wound area from 9.4 cm2 to 6.2 cm2, length from 6.4 cm to 3.9 cm, and width from 2.8 cm to 2.1 cm (p<0.001). Additionally, a substantial clinical improvement was noted in both the WBS with a 31.25% increase and the BWAT with a 20.00% increase (p<0.001). It was also found a significant correlation between the planimetric and clinical outcomes for both tools: WBS (r=-0.446, p=0.012) and BWAT (r=0.327, p=0.073). Conclusion The ESWT application yields substantial immediate clinical effects that support the healing of chronic wounds in older adults. Even a single ESWT session can prove to be clinically effective and beneficial in the management of chronic wounds.
Collapse
Affiliation(s)
- Robert Dymarek
- Department of Physiotherapy, Wroclaw Medical University, Wroclaw, Poland
| | - Izabela Kuberka
- Division of Anaesthetic and Surgical Nursing, Wroclaw Medical University, Wroclaw, Poland
| | - Karolina Walewicz
- Medical Institute, Jan Grodek State University in Sanok, Sanok, Poland
| | - Jakub Taradaj
- Institute of Physiotherapy and Health Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland
| | - Joanna Rosińczuk
- Division of Internal Medicine Nursing, Wroclaw Medical University, Wroclaw, Poland
| | - Mirosław Sopel
- Faculty of Medicine, Wrocław University of Science and Technology, Wroclaw, Poland
| |
Collapse
|
|
3
|
Reinhardt N, Schmitz C, Milz S, de la Fuente M. Influence of the skull bone and brain tissue on the sound field in transcranial extracorporeal shock wave therapy: an ex vivo study. BIOMED ENG-BIOMED TE 2024; 69:27-37. [PMID: 37732512 DOI: 10.1515/bmt-2022-0332] [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: 08/25/2022] [Accepted: 08/21/2023] [Indexed: 09/22/2023]
Abstract
OBJECTIVES Focused ultrasound is mainly known for focal ablation and localized hyperthermia of tissue. During the last decade new treatment options were developed for neurological indications based on blood-brain-barrier opening or neuromodulation. Recently, the transcranial application of shock waves has been a subject of research. However, the mechanisms of action are not yet understood. Hence, it is necessary to know the energy that reaches the brain during the treatment and the focusing characteristics within the tissue. METHODS The sound field of a therapeutic extracorporeal shock wave transducer was investigated after passing human skull bone (n=5) or skull bone with brain tissue (n=2) in this ex vivo study. The maximum and minimum pressure distribution and the focal pressure curves were measured at different intensity levels and penetration depths, and compared to measurements in water. RESULTS Mean peak negative pressures of up to -4.97 MPa were reached behind the brain tissue. The positive peak pressure was attenuated by between 20.85 and 25.38 dB/cm by the skull bone. Additional damping by the brain tissue corresponded to between 0.29 and 0.83 dB/cm. Compared to the measurements in water, the pulse intensity integral in the focal spot was reduced by 84 % by the skull bone and by additional 2 % due to the brain tissue, resulting in a total damping of up to 86 %. The focal position was shifted up to 8 mm, whereas the basic shape of the pressure curves was preserved. CONCLUSIONS Positive effects may be stimulated by transcranial shock wave therapy but damage cannot be excluded.
Collapse
Affiliation(s)
- Nina Reinhardt
- Chair of Medical Engineering, RWTH Aachen University, Aachen, Germany
| | - Christoph Schmitz
- Chair of Neuroanatomy, Institute of Anatomy, Faculty of Medicine, LMU Munich, Munich, Germany
| | - Stefan Milz
- Chair of Neuroanatomy, Institute of Anatomy, Faculty of Medicine, LMU Munich, Munich, Germany
| | | |
Collapse
|
|
4
|
Raja JM, Maturana MA, Kayali S, Khouzam A, Efeovbokhan N. Diabetic foot ulcer: A comprehensive review of pathophysiology and management modalities. World J Clin Cases 2023; 11:1684-1693. [PMID: 36970004 PMCID: PMC10037283 DOI: 10.12998/wjcc.v11.i8.1684] [Citation(s) in RCA: 37] [Impact Index Per Article: 18.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2022] [Revised: 01/08/2023] [Accepted: 02/17/2023] [Indexed: 03/07/2023] Open
Abstract
Diabetic foot ulcer (DFU) is a debilitating and severe manifestation of uncontrolled and prolonged diabetes that presents as ulceration, usually located on the plantar aspect of the foot. Approximately 15% of individuals with diabetes will eventually develop DFU, and 14%-24% of them will require amputation of the ulcerated foot due to bone infection or other ulcer-related complications. The pathologic mechanisms underlying DFU are comprise a triad: Neuropathy, vascular insufficiency, and secondary infection due to trauma of the foot. Standard local and invasive care along with novel approaches like stem cell therapy pave the way to reduce morbidity, decrease amputations, and prevent mortality from DFU. In this manuscript, we review the current literature with focus on the pathophysiology, preventive options, and definitive management of DFU.
Collapse
Affiliation(s)
- Joel M Raja
- Department of Internal Medicine, University of Tennessee Health Science Center, Memphis, TN 38119, United States
| | - Miguel A Maturana
- Department of Internal Medicine, University of Tennessee Health Science Center, Memphis, TN 38119, United States
| | - Sharif Kayali
- Department of Internal Medicine, University of Tennessee Health Science Center, Memphis, TN 38119, United States
| | - Amir Khouzam
- Department of Internal Medicine, University of Tennessee Health Science Center, Memphis, TN 38119, United States
| | | |
Collapse
|
|
5
|
Medeiros S, Rodrigues A, Costa R. Physiotherapeutic interventions in the treatment of patients with diabetic foot ulcers: a systematic literature review. Physiotherapy 2023; 118:79-87. [PMID: 36244842 DOI: 10.1016/j.physio.2022.09.006] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2021] [Revised: 05/11/2022] [Accepted: 09/09/2022] [Indexed: 02/07/2023]
Abstract
BACKGROUND Diabetic foot ulcers are chronic wounds that are difficult to heal, with a high rate of recurrent hospitalizations. Due to its multifactorial complexity, treatment must be considered as multidisciplinary, with adjuvant therapy required to aid the healing process. OBJECTIVES To identify physiotherapeutic interventions for the treatment of diabetic foot ulcers through a systematic literature review. DATA SOURCES PubMed, Cochrane Library, SciELO and Web of Science were searched in April 2020. STUDY SELECTION OR ELIGIBILITY CRITERIA The inclusion criteria for this review were: randomised controlled trial published in the last 5 years; written in Portuguese, English or Spanish; subjects aged> 18 years with a diagnosis of diabetic foot ulcers; and physiotherapeutic intervention in combination with multidisciplinary wound management. The methodological quality was assessed using the PEDro scale. RESULTS Eight studies were included. Physiotherapists can treat diabetic foot ulcers using therapeutic exercises, electrotherapy, manual therapy and assistive technologies. All physiotherapeutic interventions were adjuvant to standard treatment for wounds provided by other health professionals. The main outcomes were wound size and healing time, with highly favourable results obtained for the experimental groups compared with the control groups. CONCLUSIONS Therapeutic exercise, electrotherapy, manual therapy and assistive technologies are physiotherapeutic modalities that, when combined with standard treatment, have been shown to be beneficial in the healing of diabetic foot ulcers.
Collapse
Affiliation(s)
- Sabrina Medeiros
- School of Health Sciences, University of Aveiro, Aveiro, Portugal.
| | | | - Rui Costa
- School of Health Sciences, University of Aveiro, Aveiro, Portugal
| |
Collapse
|
|
6
|
Hitchman L, Totty J, Smith GE, Carradice D, Twiddy M, Iglesias C, Russell D, Chetter IC. Extracorporeal shockwave therapy compared with standard care for diabetic foot ulcer healing: An updated systematic review. Int Wound J 2022. [DOI: 10.1111/iwj.14035] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2022] [Accepted: 11/16/2022] [Indexed: 12/04/2022] Open
Affiliation(s)
| | - Joshua Totty
- Hull York Medical School York UK
- Hull University Teaching Hospitals NHS Trust Hull UK
| | - George E. Smith
- Hull York Medical School York UK
- Hull University Teaching Hospitals NHS Trust Hull UK
| | - Daniel Carradice
- Hull York Medical School York UK
- Hull University Teaching Hospitals NHS Trust Hull UK
| | - Maureen Twiddy
- Institute of Clinical and Applied Health Research Hull York Medical School York UK
| | | | - David Russell
- Leeds University Teaching Hospitals Leeds UK
- University of Leeds Leeds UK
| | - Ian C. Chetter
- Hull York Medical School York UK
- Hull University Teaching Hospitals NHS Trust Hull UK
| |
Collapse
|
|
7
|
Chen L, Zhou R, Sun F, Weng Y, Ye L, Yang P. Efficacy and safety of the extracorporeal shockwave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial. Trials 2020; 21:630. [PMID: 32641142 PMCID: PMC7346340 DOI: 10.1186/s13063-020-04564-z] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2020] [Accepted: 06/26/2020] [Indexed: 02/08/2023] Open
Abstract
Background Postherpetic neuralgia (PHN) is one of the most common types of chronic neuropathic pain, which seriously affects quality of the life because of pain severity and poor response to the currently available treatments. The main strategies for PHN management are medication and invasive interventional therapies; however, these approaches have many adverse effects, so it is important to find another effective and safe treatment for PHN. Methods A single-center, single-blind randomized clinical trial will evaluate 98 study participants randomized in a 1:1 ratio into control and experimental groups. The control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will receive extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12. The plasma levels of tumor necrosis factor-α and interleukin-6 will be assessed before and after ESWT to explore the biochemical mechanisms of ESWT in the treatment of PHN. Discussion This randomized controlled trial will evaluate the effectiveness and safety of ESWT in patients with PHN and thus will provide clinical evidence for its use in the management of PHN and explore the potential biochemical mechanisms of this treatment. Trial registration www.ChiCTR.org.cn, identifier: ChiCTR1900025828. Registered on 10 September 2019
Collapse
Affiliation(s)
- Lu Chen
- Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China
| | - Ruihao Zhou
- Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China
| | - Fuguo Sun
- Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China
| | - Yan Weng
- Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China
| | - Ling Ye
- Department of Pain Management, West China Hospital, Sichuan University, Guoxuexiang No. 37, Chengdu, 610041, People's Republic of China.
| | - Pingliang Yang
- Department of Anesthesiology, The First Affiliated Hospital of Chengdu Medical College, Xindu, 610500, Sichuan, People's Republic of China.
| |
Collapse
|