Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adhesive Capsulitis of Shoulder
- Sponsor
- Taif University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Visual analogue scale
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Hosam Alzahrani
Assistant Professor; Department of Physical Therapy
Taif University
Eligibility Criteria
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
- •Glenohumeral or Acromioclavicular arthritis
- •Inflammatory disorders
- •Bleeding disorders
- •Presence of severe osteoporosis
- •Pulmonary diseases
- •Any neuromuscular disorders
- •Pregnancy
Outcomes
Primary Outcomes
Visual analogue scale
Time Frame: baseline, and at 7 and 12 weeks
Visual analogue scale for pain intensity measurement (0 (no pain) - 10 (worst pain))
Disabilities of the Arm, Shoulder, and Hand Quick version (DASH)
Time Frame: baseline, and at 7 and 12 weeks
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. The scale ranges from 0 to 100; where higher score indicates higher disability.
Secondary Outcomes
- Short Form-12(baseline, and at 7 and 12 weeks)
- Range of Motion (passive and active)(baseline, and at 7 and 12 weeks)
- Depression Anxiety Stress Scales (DASS-12)(baseline, and at 7 and 12 weeks)