Adhesive Capsulitis of Shoulder Clinical Trial
Official title:
Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder: A Randomized Controlled Trial
NCT number | NCT05771220 |
Other study ID # | A01510 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2023 |
Est. completion date | December 15, 2023 |
Verified date | June 2024 |
Source | Taif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to evaluate the combined effects of radial extracorporeal shockwave therapy (rESWT) and evidence-based physical therapy (EBPT) interventions for patients with adhesive capsulitis. The main questions it aims to answer are: What is the effectiveness of combining rESWT with EBPT interventions for the management of adhesive capsulitis compared to EBPT alone? How does the combination of rESWT and EBPT affect pain, range of motion, and functional outcomes in patients with adhesive capsulitis? Researchers will compare rESWT plus EBPT to a sham rESWT plus EBPT to see if rESWT provides better results for subjects with adhesive capsulitis. The study will randomly assign participants to receive either rESWT plus EBPT or sham rESWT plus EBPT over a 6-week intervention period. The primary outcomes will be pain and disability, while secondary outcomes will include shoulder range of motion, psychological distress, and health-related quality of life. These outcomes will be assessed at baseline, post-intervention, and 12 weeks post-randomization.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 15, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Having a relapsed or episode of pain score =5 at the assessment with a past history of pain for at least 2 weeks. - phase 1 or 2 frozen shoulder confirmed by a physician - ROM restriction (>75% ROM loss in =2 directions including abduction, flexion and external rotation) - no treatment other than analgesics with unresponsive ROM restriction for the past 2 months - unwilling or waiting and did not undergo joint injection - Diagnosed with shoulder adhesive capsulitis, - =18 years - Diabetes mellitus Exclusion Criteria: - bilateral shoulder involvement - History of previous surgery on the shoulder - Shoulder fracture - Cancer - Glenohumeral or Acromioclavicular arthritis - Inflammatory disorders - Bleeding disorders - Presence of severe osteoporosis - Pulmonary diseases - Any neuromuscular disorders - Pregnancy - Implanted pacemaker |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Al-Thager General Hospital | Jeddah | Mecca |
Lead Sponsor | Collaborator |
---|---|
Taif University |
Saudi Arabia,
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Muthukrishnan R, Rashid AA, Al-Alkharji F. The effectiveness of extracorporeal shockwave therapy for frozen shoulder in patients with diabetes: randomized control trial. J Phys Ther Sci. 2019 Jul;31(7):493-497. doi: 10.1589/jpts.31.493. Epub 2019 Jul 2. — View Citation
Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186. — View Citation
Park C, Lee S, Yi CW, Lee K. The effects of extracorporeal shock wave therapy on frozen shoulder patients' pain and functions. J Phys Ther Sci. 2015 Dec;27(12):3659-61. doi: 10.1589/jpts.27.3659. Epub 2015 Dec 28. — View Citation
Qiao HY, Xin L, Wu SL. Analgesic effect of extracorporeal shock-wave therapy for frozen shoulder: A randomized controlled trial protocol. Medicine (Baltimore). 2020 Jul 31;99(31):e21399. doi: 10.1097/MD.0000000000021399. — View Citation
Struyf F, Meeus M. Current evidence on physical therapy in patients with adhesive capsulitis: what are we missing? Clin Rheumatol. 2014 May;33(5):593-600. doi: 10.1007/s10067-013-2464-3. Epub 2013 Dec 28. — View Citation
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Yuan X, Zhou F, Zhang L, Zhang Z, Li J. Analgesic Effect of Extracorporeal Shock Wave Treatment Combined with Fascial Manipulation Theory for Adhesive Capsulitis of the Shoulder: A Retrospective Study. Biomed Res Int. 2018 Jan 18;2018:3450940. doi: 10.115 — View Citation
Zhang R, Wang Z, Liu R, Zhang N, Guo J, Huang Y. Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2022 Feb 4;10(2):23259671211062222. doi: 10.1177/23259671211062222. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analogue scale | Visual analogue scale for pain intensity measurement | baseline, and at 7 and 12 weeks | |
Primary | Disabilities of the Arm, Shoulder, and Hand Quick version (DASH) | Shoulder disability was measured using the Disabilities of the Arm, Shoulder, and Hand Quick version (DASH) questionnaire (0-100). It's an 11-item questionnaire that measures a patient's ability to perform specific upper extremity tasks, and higher scores on the scale indicate a higher disability | baseline, and at 7 and 12 weeks | |
Secondary | Depression Anxiety Stress Scales (DASS-12) | Depression Anxiety Stress Scales, is made up of 12 self-report items | baseline, and at 7 and 12 weeks | |
Secondary | SF-12 | The 12-Item Short Form Health Survey questionnaire (SF-12) is a very popular instrument for evaluating Health-Related Quality of Life. | baseline, and at 7 and 12 weeks | |
Secondary | Range of Motion (passive and active) | Range of Motion is measured by goniometer | baseline, and at 7 and 12 weeks |
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