Efficacy of Combined Intra-Articular Hyaluronic Acid and Ketorolac Versus Ketorolac Alone in the Treatment of Adhesive Capsulitis: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Shoulder function (Thai SPADI score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years
- •Symptom duration of 1-12 months
- •Provision of informed consent.
排除标准
- •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
研究组 & 干预措施
Hyaluronic Acid and Ketorolac injection
Participants received a single intra-articular injection of Hyaluronic Acid and Ketorolac
干预措施: Intra-articular Hyaluronic Acid and Ketorolac (Drug)
Ketorolac injection
Participants received a single intra-articular injection of ketorolac
干预措施: Intra-articular Ketorolac (Drug)
结局指标
主要结局
Shoulder function (Thai SPADI score)
时间窗: 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)
次要结局
- Pain intensity (VAS score)(Baseline, 2, 6, 12, and 24 weeks post-injection)
- Passive range of motion (PROM)(Baseline, 2, 6, 12, and 24 weeks post-injection)
- Adverse events(0-24 weeks post-injection)