Adhesive Capsulitis of the Shoulder
Conditions
Keywords
Adhesive capsulitis, Frozen shoulder, Shoulder pain, Hyaluronic acid, Ketorolac, Intra-articular injection, Randomized controlled trial, Range of motion
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 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.
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 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.
Interventions
DRUGIntra-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.
DRUGIntra-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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants randomized in a 1:1 ratio to receive either intra-articular HA+ketorolac or ketorolac alone, each followed by standardized rehabilitation
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder function (Thai SPADI score) | Baseline, 2, 6, 12, and 24 weeks post-injection | Shoulder Pain and Disability Index (Thai version), patient-reported outcome measure, score range 0-100 (higher score = worse disability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (VAS score) | Baseline, 2, 6, 12, and 24 weeks post-injection | Visual Analog Scale for shoulder pain, 0-10 (higher score = worse pain) |
| Passive range of motion (PROM) | Baseline, 2, 6, 12, and 24 weeks post-injection | Passive range of motion of the affected shoulder (flexion, extension, abduction, adduction, internal and external rotation) measured with goniometer in degrees |
| Adverse events | 0-24 weeks post-injection | Number and type of treatment-related adverse events (mild, moderate, or severe) reported by participants or observed by investigators |
Countries
Thailand
Outcome results
None listed