Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder

This randomized controlled trial evaluates the clinical efficacy of ultrasound-guided intra-articular hyaluronic acid injection combined with rehabilitation in patients with adhesive capsulitis (frozen shoulder). Participants were randomly assigned to either an injection plus rehabilitation group or a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid once weekly for three weeks, along with a standardized rehabilitation program for six weeks. The control group received the same rehabilitation program without injection. Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome was the change in the Shoulder Pain and Disability Index (SPADI) total score. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder range of motion. The trial was registered retrospectively at ClinicalTrials.gov (NCT07570095) after study completion due to administrative oversight. The study was conducted in accordance with the protocol approved by the Tri-Service General Hospital Institutional Review Board (approval no. C202205160) prior to enrollment. The IRB-approved protocol specified the eligibility criteria and outcome measures reported in this record; discrepancies in the initial registry entry have been corrected in this amendment.

NCT Number	NCT07570095
Lead Sponsor	Tri-Service General Hospital
Conditions	Adhesive Capsulitis, Frozen Shoulder
Enrollment	60 participants
Start Date	2025-02-05
Primary Completion	2025-03-05 (estimated)
Study Completion	2026-04-28 (estimated)
Updated on ClinicalTrials.gov	2026-05-15