NCT05771220

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

Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Taif University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adhesive Capsulitis of Shoulder

Interventions

Type	Name	Description
OTHER	radial extracorporeal shockwave therapy+ evidence-based physical therapy	The experimental group received six sessions of rESWT over six weeks in addition to an EBPT program. The rESWT procedure involved applying shockwaves to the affected area using a radial probe, with sessions lasting 10-15 minutes and consisting of up to 2000 impulses delivered at a frequency of 3-6 pulses per second and an energy intensity level of 1.8 bar, based on patient tolerance. Patients were seated or lying down during the rESWT procedure, with gel or oil applied to facilitate shockwave transmission through the skin. Additionally, participants received a 30-minute exercise program twice a week for 6 weeks, which included hot packs, stretching, range of motion exercises, and isometric shoulder and scapular exercises. They were also instructed to perform the same exercises at home daily.
OTHER	sham radial extracorporeal shockwave therapy+ evidence-based physical therapy	The participants in the control group received six weeks of sham rESWT (radial extracorporeal shock wave therapy) combined with the EBPT (evidence-based physical therapy) program. The sham rESWT involved six sessions with a maximum of 200 impulses delivered at a low intensity, with the applicator placed on the affected area for the same duration as the experimental group. Additionally, participants received a 30-minute exercise program twice a week for 6 weeks, which included hot packs, stretching, range of motion exercises, and isometric shoulder and scapular exercises. They were also instructed to perform the same exercises at home daily.

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-10-15
• Completion: 2023-12-15
• First posted: 2023-03-16
• Last updated: 2024-07-22

Locations

1 site across 1 country: Saudi Arabia