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

Not Applicable

Completed

• Conditions: Adhesive Capsulitis of Shoulder
• Interventions: Other: radial extracorporeal shockwave therapy+ evidence-based physical therapy; Other: sham radial extracorporeal shockwave therapy+ evidence-based physical therapy

• Registration Number: NCT05771220
• Lead Sponsor: Taif University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-16
• Study Start: 2023-05-15
• Primary Completion: 2023-10-15
• Study Completion: 2023-12-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radial extracorporeal shockwave therapy+ evidence-based physical therapy	radial extracorporeal shockwave therapy+ evidence-based physical therapy	radial extracorporeal shockwave therapy + evidence-based physical therapy
sham radial extracorporeal shockwave therapy + evidence-based physical therapy	sham radial extracorporeal shockwave therapy+ evidence-based physical therapy	sham radial extracorporeal shockwave therapy+ evidence-based physical therapy

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	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)	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 Outcome Measures

Name	Time	Method
Short Form-12	baseline, and at 7 and 12 weeks	The 12-Item Short Form Health Survey questionnaire (SF-12; 0-100) is a very popular instrument for evaluating Health-Related Quality of Life.HIgher score on the scale indicates better Health-Related Quality of Life.
Range of Motion (passive and active)	baseline, and at 7 and 12 weeks	Range of Motion is measured by goniometer. Higher score on goniometer indicates better range of motion.; Flexion: 0-180 Abduction: 0-180 Internal rotation: 0-90 External rotation: 0-90
Depression Anxiety Stress Scales (DASS-12)	baseline, and at 7 and 12 weeks	Depression Anxiety Stress Scales, is made up of 12 self-report items. It is a 12-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress. It ranges 0-144, where higher score on the scale denotes higher endorsement of mental distress symptoms.

Trial Locations

Locations (1)

Al-Thager General Hospital; 🇸🇦 Jeddah, Mecca, Saudi Arabia