Status:
COMPLETED
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.
Lead Sponsor:
Mahidol University
Conditions:
Adhesive Capsulitis of the Shoulder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 capsulit...
Detailed Description
Adhesive capsulitis, or frozen shoulder, is characterized by pain and stiffness due to capsular inflammation and fibrosis. Corticosteroid injections are commonly used but may be contraindicated in som...
Eligibility Criteria
Inclusion
- 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
- Adults aged 18-70 years
- Symptom duration of 1-12 months
- Provision of informed consent.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT07183436
Start Date
November 1 2023
End Date
July 1 2025
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400