Additive Effects of Hyaluronidase in Intra-articular Steroid Injection Treating the Initial Stage of Adhesive Capsulitis for Shoulder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of visual analogue scale (VAS)
研究概览
简要总结
Adhesive capsulitis (AC) is painful and disabling condition that is associated with a gradual loss of shoulder motion. Intra-articular steroid injection is a common treatment in the initial painful stage of AC, and its use in combination with hyaluronidase may offer increased therapeutic efficacy owing to synergistic effects. We determined the therapeutic efficiency of the co-administration of hyaluronidase in early AC by evaluating symptomatic, anthropometric, and imaging changes.
详细描述
We enrolled eligible patients with primary adhesive capsulitis in the initial stage.The subjects were randomly assigned into 3 groups to receive ultrasound-guided intra-articular injections with 20 mg (group A) and 40 mg triamcinolone acetonide (group B) and 20 mg acetonide combined with hyaluronidase (group C). The outcome measures included the visual analogue scale (VAS), the shoulder disability questionnaire (SDQ), abduction and external rotation range of motion, and intra-sheath fluid (ISF) before treatment and at 2, 4, 8, and 16 weeks after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal findings on simple x-rays of the shoulder but limitations in passive range of motion on physical examination
- •Increased intra-sheath fluid (ISF) sufficient to encircle the long head of the biceps tendon within the upper portion of the bicipital groove of the humerus.
排除标准
- •Ultrasonographic diagnosis of other concomitant fundamental abnormalities causing shoulder pain such as rotator cuff tear, bicipital tendon rupture, calcific tendinopathy, and subacromial-subdeltoid bursitis
- •A history of shoulder injury
- •A history of more than 1 year of conservative treatment for chronic shoulder pain
- •Corticosteroid or hyaluronidase injections within the prior 6 months
- •Hemiplegic shoulder
- •Self-reported history consistent with scapula fracture or disarticulation
- •Ipsilaterally cervical herniated intervertebral disc or brachial plexus injury
- •Diabetes mellitus refractory to insulin therapy or glycated hemoglobin greater than 6.5
- •Refusal to participate in this study
研究组 & 干预措施
Group A
Intra-articular injection, 20 mg (0.5 mL) of triamcinolone acetonide mixed with 2 mL of 2% lidocaine and 7.5 mL of normal saline
干预措施: Triamcinolone Acetonide 40mg/mL (Drug)
Group B
40 mg (1 mL) of triamcinolone acetonide mixed with 2 mL of 2% lidocaine and 7.0 mL of normal saline
干预措施: Triamcinolone Acetonide 40mg/mL (Drug)
Group C
20 mg (0.5 mL) of triamcinolone acetonide and 1 mL of hyaluronidase mixed with 2 mL of 2% lidocaine and 6.5 mL of normal saline
干预措施: Triamcinolone Acetonide 40mg/mL (Drug)
Group C
20 mg (0.5 mL) of triamcinolone acetonide and 1 mL of hyaluronidase mixed with 2 mL of 2% lidocaine and 6.5 mL of normal saline
干预措施: Hyaluronidase Injection (Drug)
结局指标
主要结局
Change of visual analogue scale (VAS)
时间窗: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
Evaluation for the change of VAS that means average degree of shoulder pain for 24 hours before the evaluation (from 0 to 10 points)
次要结局
- Change of degree for the flexion motion of shoulder(Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection)
- Change of area for the intra-sheath fluid(Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection)
- Change of shoulder disability questionnaire (SDQ)(Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection)
- Change of degree for the abduction motion of shoulder(Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection)
研究者
Wonjae Lee, MD PhD
Director for the department of physical medicine and rehabilitation
Veterans Health Service Medical Center, Seoul, Korea