Frozen Shoulder Clinical Trial
Official title:
Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder: A Double-blinded, Randomized Controlled Trail
The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with frozen shoulder
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports. 2. The symptoms persist for more than 3 months. 3. There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation. Exclusion Criteria: 1. Shoulder musculoskeletal ultrasound reveals a full-thickness tear or massive tear of the shoulder rotator cuff tendons or calcific tendinitis. 2. Systemic rheumatic disease. 3. History of shoulder fracture or previous surgical treatment of the shoulder joint. 4. Acute cervical nerve root compression. 5. Patients with instability (e.g., those with symptoms of internal bleeding) or cancer patients. 6. Received shoulder injections for treatment within the past 3 months. 7. Impaired cognitive function that prevents the patient from providing informed consent or participating in rehabilitation therapy. 8. Pregnant or breastfeeding women. 9. Meets any of the contraindications for high-energy electromagnetic pulse therapy: organ transplant recipients; individuals with implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and insulin supplementation. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Tri-service general hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Tri-Service General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain Visual Analogue Scale(VAS) | The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful. | the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months | |
Secondary | Change in Shoulder Pain and Disability Index (SPADI) | Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability. | the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months | |
Secondary | Blood test | Perform blood test to analysis the change of interleukin-1ß, interleukin-6, interleukin-10 | the change from baseline, post-intervention 1 and 6 months | |
Secondary | Blood test | Perform blood test to analysis the change of transforming growth factor-ß(TGF-ß) | the change from baseline, post-intervention 1 and 6 months |
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