Is Extracorporeal Shockwave Therapy Combined with Evidence-based Physical Therapy More Effective Than Evidence-based Physical Therapy Alone for Adhesive Capsulitis? A Randomized Controlled Trial

Research Objectives: To evaluate the effect of radial extracorporeal shockwave therapy (rESWT) combined with evidence-based physical therapy (EBPT) on adhesive capsulitis (AC).

Design: Single-blind randomized controlled trial (participants).

Setting: This trial was registered prospectively at the ClinicalTrials.gov (ID: NCT05771220). It received approval from the Institutional Review Board at Health Affairs in Jeddah, Saudi Arabia (No. A01510) and was conducted in accordance with the principles of the Declaration of Helsinki.

Participants: This study included 30 participants diagnosed with adhesive capsulitis of shoulder. They were recruited from the outpatient clinic of the physical therapy department at Al Thagher General Hospital, Jeddah, Saudi Arabia. Three experienced physiotherapists with over 10 years of experience have examined, assessed, and recruited participants for eligibility.

Interventions: Participants were randomly assigned to either the experimental group, which received rESWT combined with EBPT, or the control group, which received sham rESWT combined with EBPT. Both groups followed an EBPT program including a 10-minute hot pack, stretching exercises, pendulum free range of motion exercises (3 sets of 10 repetitions), and isometric shoulder and scapular retraction muscle exercises (3 sets of 10 repetitions of 10-second holds). The program lasted for 30 minutes per session and was conducted twice weekly for 12 weeks. Additionally, participants were instructed to perform the same exercise program at home daily throughout the study.

Main Outcome Measures: The primary outcomes included pain (measured by Visual Analog Scale) and disability (short form of Disabilities of the Arm, Shoulder and Hand). The secondary outcomes included shoulder range of motion (ROM; goniometer), psychological distress (Depression Anxiety and Stress Scale-12), and health-related quality of life (HRQoL; Short Form-12). The outcomes were assessed at baseline, post-intervention, and 12-week post-randomization.

Results: This study found that participants in the experimental group had better improvement than the control group in pain immediately post-intervention and at 12 weeks, and in disability at 12 weeks. Experimental participants showed better AROM of the shoulder in flexion, abduction, internal rotation at 12 weeks; and better external rotation at 7 weeks and at 12 weeks. Experimental participants achieved better PROM in abduction and external rotation immediately post-intervention; and better flexion, abduction, and external rotation at 12 weeks. Experimental participants achieved better HRQoL at 12 weeks.

Conclusions: The combinatory therapy of rESWT and EBPT was effective in improving pain, disability, ROM, and HRQoL in patients with AC.

Author(s) Disclosures: We would like to disclose that there are no financial disclosures or conflicts of interest associated with this study.