The Efficacy of Ultrasound-guided Hydrodilatation With Hyaluronic Acid for Patients With Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- change in constant shoulder score
研究概览
简要总结
This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis.
详细描述
Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis.
Design: a prospective, single-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 hyaluronic acid under ultrasonographic guidance plus PT) and group 2 (PT alone). 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, Constant shoulder score, Shoulder Pain And Disability Index, and the Short Form-36
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a duration of complaints more than 3 months
- •a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
排除标准
- •prior manipulation of the affected shoulder under anesthesia;
- •other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
- •neurologic deficits affecting shoulder function in normal daily activities;
- •shoulder pain caused by cervical radiculopathy
- •a history of drug allergy to hyaluronic acid;
- •pregnancy or lactation;
- •received injection into the affected shoulder during the preceding 3 months
研究组 & 干预措施
physical therapy and hyaluronic acid
patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy
干预措施: hyaluronic acid (hyruan) (Drug)
physical therapy and hyaluronic acid
patient received ultrasound-guided hydrodilatation with hyaluronic acid plus physical therapy
干预措施: physical therapy (Other)
physical therapy only
patient received physical therapy only
干预措施: physical therapy (Other)
结局指标
主要结局
change in constant shoulder score
时间窗: at 6, 12 wk
visual analog scale
次要结局
- change in glenohumeral joint range of motion(at 6, 12 wk)
- change in Short Form-36(at 6, 12 wk)
- change in pain intensity(at 6, 12 wk)
- change in Shoulder Pain And disability index(at 6, 12 wk)