Steroid and Sodium Hyaluronate Hydrodilatation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- change in pain intensity
研究概览
简要总结
This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.
详细描述
Design: a prospective, double-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index
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)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 35-65 years
- •onset of shoulder stiffness since over a month
- •limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.
排除标准
- •ultrasound findings of rotator cuff tears,
- •plain radiography findings of significant glenohumeral joint arthritis,
- •accompanying cervical radiculopathy,
- •systemic inflammatory joint disease,
- •intraarticular injection into the glenohumeral joint within the past 3 months
- •history of surgery on the affected shoulders,
- •regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,
- •allergy to corticosteroid or lidocaine.
研究组 & 干预措施
hydrodilatation with steroid
patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine
干预措施: normal saline (Drug)
hydrodilatation with steroid
patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine
干预措施: lidocaine hydrochloride (Drug)
hydrodilatation with steroid
patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine
干预措施: Triamcinolone Acetonide (Drug)
hydrodilatation with hyaluronic acid and steroid
patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine
干预措施: (Sodium Hyaluronate (Hyruan One , LG) (Drug)
hydrodilatation with hyaluronic acid and steroid
patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine
干预措施: lidocaine hydrochloride (Drug)
hydrodilatation with hyaluronic acid and steroid
patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
change in pain intensity
时间窗: 0, 6, 12weeks
pain intensity was measured by visual analog scale (0-10)
次要结局
- change in glenohumeral joint range of motion(0, 6, 12weeks)
- change in Shoulder Pain And disability index(0, 6, 12 weeks)