Efficacy of Combined Intra-Articular Hyaluronic Acid and Ketorolac versus Ketorolac Alone in the Treatment of Adhesive Capsulitis: A Randomized Controlled Trial

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230908006

Enrollment

Registered

2023-09-08

Start date

2023-11-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The patients with unilateral adhesive capsulitis who had conservative treatment more than 1 month adhesive capsulitis, frozen shoulder

Interventions

Intra-articular hyaluronic acid with ketorolac injection affected shoulder with posterior approach of glenohumeral joint by orthopedics sport medicine under ultrasound guidance Dose : Hyaluronic acid

Experimental Drug,Active Comparator Drug

Hyaluronic acid with ketorolac intra-articular injection,Ketorolac intra-articular injection

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Eligible participants were adults diagnosed with adhesive capsulitis defined by limitation of shoulder motion more than 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 criteria

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

Design outcomes

Primary

Measure	Time frame
Shoulder function Baseline, 2, 6, 12, and 24 weeks post-injection Thai SPADI score	—

Secondary

Measure	Time frame
Passive range of motion Baseline, 2, 6, 12, and 24 weeks post-injection Goniometer,Pain score Baseline, 2, 6, 12, and 24 weeks post-injection Visual analog scale score,Analgesic medication use 0-24 weeks post-injection Logbook,Adverse events 0-24 weeks post-injection Logbook	—

Countries

Thailand

Contacts

Public ContactPratantat Charoenchaipong

Faculty of Medicine Ramathibodi Hospital, Mahidol University

pratantat@gmail.com0853318301

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026