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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid and Ketorolac injection | Experimental | Participants received a single intra-articular injection of Hyaluronic Acid and Ketorolac |
|
| Ketorolac injection | Active Comparator | Participants received a single intra-articular injection of ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular Hyaluronic Acid and Ketorolac | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder function (Thai SPADI score) | Shoulder Pain and Disability Index (Thai version), patient-reported outcome measure, score range 0-100 (higher score = worse disability) | Baseline, 2, 6, 12, and 24 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (VAS score) | Visual Analog Scale for shoulder pain, 0-10 (higher score = worse pain) | Baseline, 2, 6, 12, and 24 weeks post-injection |
| Passive range of motion (PROM) | Passive range of motion of the affected shoulder (flexion, extension, abduction, adduction, internal and external rotation) measured with goniometer in degrees |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pratantat Charoenchaipong, MD | Ramathibodi Hospital | Principal Investigator |
| Sorawut Thamyongkit, MD | Chakri Naruebodindra Medical Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21248398 | Result | Lee SC, Rha DW, Chang WH. Rapid analgesic onset of intra-articular hyaluronic acid with ketorolac in osteoarthritis of the knee. J Back Musculoskelet Rehabil. 2011;24(1):31-8. doi: 10.3233/BMR-2011-0272. | |
| 29417082 | Result | Taheri P, Dehghan F, Mousavi S, Solouki R. Comparison of Subacromial Ketorolac Injection versus Corticosteroid Injection in the Treatment of Shoulder Impingement Syndrome. J Res Pharm Pract. 2017 Oct-Dec;6(4):223-227. doi: 10.4103/jrpp.JRPP_17_57. |
| Label | URL |
|---|---|
| Randomized, double-blind, placebo-controlled trial of 60 patients with adhesive capsulitis. Participants were randomized into four arms (saline, corticosteroid, hyaluronic acid, corticosteroid + hyaluronic acid) | View source |
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Participants randomized in a 1:1 ratio to receive either intra-articular HA+ketorolac or ketorolac alone, each followed by standardized rehabilitation
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|
|
| Intra-articular Ketorolac | 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. |
|
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| Baseline, 2, 6, 12, and 24 weeks post-injection |
| Adverse events | Number and type of treatment-related adverse events (mild, moderate, or severe) reported by participants or observed by investigators | 0-24 weeks post-injection |
| 32313809 | Result | Xu J, Qu Y, Li H, Zhu A, Jiang T, Chong Z, Wang B, Shen P, Xie Z. Effect of Intra-articular Ketorolac Versus Corticosteroid Injection for Knee Osteoarthritis: A Retrospective Comparative Study. Orthop J Sports Med. 2020 Apr 10;8(4):2325967120911126. doi: 10.1177/2325967120911126. eCollection 2020 Apr. |
| 35241100 | Result | Mao B, Peng R, Zhang Z, Zhang K, Li J, Fu W. The Effect of Intra-articular Injection of Hyaluronic Acid in Frozen Shoulder: a Systematic Review and Meta-analysis of Randomized Controlled Trials. J Orthop Surg Res. 2022 Mar 3;17(1):128. doi: 10.1186/s13018-022-03017-4. |
| 39353107 | Result | Uhm KE, Chang MC. Comparison of Effectiveness of Intraarticular Hyaluronate and Corticosteroid injections in Adhesive Capsulitis: A Systematic Review and Meta-analysis. Pain Physician. 2024 Sep;27(7):387-400. |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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