Clinical trial NCT05771220: Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis
Official title: Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Keywords: Frozen shoulder
Extracorporeal shockwave therapy
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, single blinded, placebo
Primary purpose: TREATMENT

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.


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
* Cancer
* Glenohumeral or Acromioclavicular arthritis
* Inflammatory disorders
* Bleeding disorders
* Presence of severe osteoporosis
* Pulmonary diseases
* Any neuromuscular disorders
* Pregnancy
* Implanted pacemaker

Primary outcomes:
measure: Visual analogue scale
timeFrame: baseline, and at 7 and 12 weeks
measure: Disabilities of the Arm, Shoulder, and Hand Quick version (DASH)
timeFrame: baseline, and at 7 and 12 weeks
Secondary outcomes:
measure: Depression Anxiety Stress Scales (DASS-12)
timeFrame: baseline, and at 7 and 12 weeks
measure: Short Form-12
timeFrame: baseline, and at 7 and 12 weeks
measure: Range of Motion (passive and active)
timeFrame: baseline, and at 7 and 12 weeks
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Al-Thager General Hospital
state: Mecca
Study officials:
References:
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