OBJECTIVE: To evaluate the therapeutic effect of combining ultrasound-guided hydrodilatation with hyaluronic acid and physical therapy compared with physical therapy alone in patients with adhesive capsulitis. DESIGN: A prospective, single-blinded, randomised controlled trial. SETTING: Single medical centre. PARTICIPANTS: Patients with adhesive capsulitis (n = 62) were divided into group A ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy (n = 31) and group B physical therapy alone (n = 31). INTERVENTIONS: Group A received three doses of ultrasound-guided hydrodilatation with hyaluronic acid-based injectates (20 mL in total). Both groups underwent structured physical therapy. OUTCOME MEASURES: The primary outcome measure was Constant score, while secondary outcomes included Shoulder Pain and Disability Index score, numerical rating scale (at rest, night, and during motion), 36 item Short Form Health Survey, and range of motion of the shoulder. All measurements were collected at baseline, 6 weeks, and 12 weeks post-injection. RESULTS: At week 12, the Constant scores were 68.29 +/- 14.55 and 62.77 +/- 14.44 for groups A and B, respectively. There was a greater reduction in the Constant score, Shoulder Pain and Disability Index, and numerical rating scale between the baseline and 6 weeks and between the baseline and 12 weeks in group A (Constant score p < 0.05, Shoulder Pain and Disability Index p < 0.01, and numerical rating scale p < 0.05). CONCLUSION: The combination of ultrasound-guided hydrodilatation with hyaluronic acid in conjunction with physical therapy provides additional benefits compared to physical therapy alone for the treatment of adhesive capsulitis at up to 12 weeks. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02708706.

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