Intra-articular Corticosteroids Are Widely Used for Adhesive Capsulitis, But Alternatives Are Req… (NCT07183436) | Clinical Trial Compass
CompletedPhase 3
Intra-articular Corticosteroids Are Widely Used for Adhesive Capsulitis, But Alternatives Are Required for Patients With Contraindications. Hyaluronic Acid (HA) and Ketorolac Have Shown Individual Benefits. However, Evidence on Their Combination Remains Limited.
Thailand56 participantsStarted 2023-11-01
Plain-language summary
This randomized, double-blind trial compared a single intra-articular injection of moderate-molecular-weight hyaluronic acid (HA) plus ketorolac with ketorolac alone in patients with adhesive capsulitis. Fifty-six participants were randomized into two equal groups and followed for 24 weeks. The primary outcome was shoulder function measured by the Thai Shoulder Pain and Disability Index (SPADI). Secondary outcomes included pain (VAS), passive range of motion (PROM), analgesic use, and adverse events. Both groups showed significant improvement in pain and function with no between-group difference in SPADI or VAS. The HA+ketorolac group demonstrated small but significant gains in external rotation and adduction. Both treatments were safe and well tolerated.
Who can participate
Age range
18 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.
Eligible participants were adults diagnosed with adhesive capsulitis defined by limitation of shoulder motion ≥25 degrees in at least two planes compared to the contralateral side
Inclusion Criteria:
* Adults aged 18-70 years
* Symptom duration of 1-12 months
* Provision of informed consent.
Exclusion Criteria:
* History of trauma or prior surgery to the affected shoulder
* Bilateral adhesive capsulitis
* Uncontrolled diabetes (HbA1C \> 7%)
* Abnormal thyroid function
* Prior intra-articular injection in the affected shoulder
* Full-thickness rotator cuff tear on imaging
* History of gastrointestinal bleeding
* Known allergy to hyaluronic acid or NSAIDs
* Systemic conditions affecting joint pain (e.g., SLE, rheumatoid arthritis, osteoarthritis)
* Neurological disorders affecting muscle strength or sensation coagulopathy or bleeding disorders withdrawal or refusal of consent at any time
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
1
Shoulder function (Thai SPADI score)
Timeframe: Baseline, 2, 6, 12, and 24 weeks post-injection