Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis

Taif University

Status: Completed

Conditions: Adhesive Capsulitis of Shoulder

Treatments: Other: radial extracorporeal shockwave therapy+ evidence-based physical therapy; Other: sham radial extracorporeal shockwave therapy+ evidence-based physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05771220

A01510

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

radial extracorporeal shockwave therapy+ evidence-based physical therapy

Experimental group

Description:

radial extracorporeal shockwave therapy + evidence-based physical therapy

Treatment:

Other: radial extracorporeal shockwave therapy+ evidence-based physical therapy

sham radial extracorporeal shockwave therapy + evidence-based physical therapy

Placebo Comparator group

Description:

sham radial extracorporeal shockwave therapy+ evidence-based physical therapy

Treatment:

Other: sham radial extracorporeal shockwave therapy+ evidence-based physical therapy