CompletedNot Applicable

Efficacy of Intra-articular Hyaluronate Injection for Adhesive Capsulitis

Taiwan46 participantsStarted 2023-08-01

Plain-language summary

Objective: To evaluate the efficacy of intra-articular hyaluronic acid (HA) injections for the treatment of adhesive capsulitis (AC) of the shoulder. Design: Prospective, randomized, parallel-group interventional trial Setting: Rehabilitation department of a medical center hospital. Participants: Participants: Patients with frozen-phase primary adhesive capsulitis Interventions: The patients received intra-articular glenohumeral joint injections of HA, 60mg, once per week for 3 consecutive weeks. Main Outcome Measures: Active and passive range of motion (ROM) of the affected shoulder; Shoulder pain and disability were measured using 2 questionnaires: the SPADI. The patients were evaluated before treatment and were reevaluated 4, 6, 8, and 26 weeks after the beginning of the treatment.

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients diagnosed with frozen shoulder by a clinical physician based on the patient's medical history, physical examination, X-ray, and ultrasound or magnetic resonance imaging reports. * Clinical course: Patients must have a pain score of less than 3, no nighttime shoulder pain, and be in the post-freezing stage, primarily presenting restricted shoulder joint range of motion. * The affected shoulder joint must have at least two angles of shoulder joint movement reduced by at least 30% compared to the healthy side: shoulder flexion, abduction, and external rotation, or a single affected side abduction angle reduced by 50% relative to the healthy side. * Age between 40 to 70 years old. Exclusion Criteria: * full-thickness tear or massive tear of the rotator cuff tendons or calcific tendinitis. * Presence of systemic rheumatic disease. * History of shoulder fracture or previous shoulder surgery. * Received shoulder injections for treatment within the last 3 months. * Acute cervical nerve root compression. * Current pregnancy or lactation. * Patients with shoulder instability or cancer. * Patients with cognitive impairment, unable to follow simple instructions, or unable to comply with the study procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Shoulder Pain and Disability Index

Timeframe: baseline, 4, 6, 8, and 26 weeks after treatment initiation

Trial details

NCT IDNCT05983081

SponsorTri-Service General Hospital (TSGH)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-14

View on ClinicalTrials.gov More Adhesive Capsulitis trials