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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-07-01

Brief Summary

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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.

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Detailed Description

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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 some patients. Hyaluronic acid (HA) and ketorolac each have shown benefit, yet evidence on their combined use is limited.

This randomized, double-blind, controlled trial enrolled 56 adults with adhesive capsulitis. Participants were randomized 1:1 to receive either HA plus ketorolac or ketorolac alone as a single intra-articular injection, followed by standardized rehabilitation. Follow-up assessments were conducted at 2, 6, 12, and 24 weeks.

The primary outcome was functional outcome measured by the Thai SPADI. Secondary outcomes included pain (VAS), PROM, analgesic use, and adverse events. Both groups improved significantly in function and pain, without significant between-group differences. However, the HA+ketorolac group showed modest but significant improvements in external rotation and adduction range of motion. Safety outcomes were favorable in both groups, with only one mild adverse event reported.

This study demonstrates that intra-articular HA combined with ketorolac and ketorolac alone are safe and effective alternatives to corticosteroid injection for adhesive capsulitis. The combination may provide additional benefit in range of motion recovery and can be considered in patients for whom corticosteroids are unsuitable.

Conditions

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Adhesive Capsulitis of the Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized in a 1:1 ratio to receive either intra-articular HA+ketorolac or ketorolac alone, each followed by standardized rehabilitation

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hyaluronic Acid and Ketorolac injection

Participants received a single intra-articular injection of Hyaluronic Acid and Ketorolac

Group Type EXPERIMENTAL

Intra-articular Hyaluronic Acid and Ketorolac

Intervention Type DRUG

Single intra-articular injection containing 2 mL moderate-molecular-weight hyaluronic acid (20 mg/2 mL), 1 mL ketorolac (30 mg/mL), and 2 mL lidocaine (10 mg/mL), total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program.

Ketorolac injection

Participants received a single intra-articular injection of ketorolac

Group Type ACTIVE_COMPARATOR

Intra-articular Ketorolac

Intervention Type DRUG

single intra-articular injection containing 1 mL ketorolac (30 mg/mL), 2 mL lidocaine (10 mg/mL), and 2 mL normal saline, total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program.

Interventions

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Intra-articular Hyaluronic Acid and Ketorolac

Single intra-articular injection containing 2 mL moderate-molecular-weight hyaluronic acid (20 mg/2 mL), 1 mL ketorolac (30 mg/mL), and 2 mL lidocaine (10 mg/mL), total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program.

Intervention Type DRUG

Intra-articular Ketorolac

single intra-articular injection containing 1 mL ketorolac (30 mg/mL), 2 mL lidocaine (10 mg/mL), and 2 mL normal saline, total volume 5 mL. Administered under aseptic technique (ultrasound-guided or landmark-based) followed by standardized rehabilitation program.

Intervention Type DRUG

Other Intervention Names

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Hyaluronic Acid and Ketorolac injection Ketorolac injection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No