Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in range of motion at 3-months intervention
研究概览
简要总结
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Therapeutic exercise, especially stretch exercise and joint mobilization, remain the mainstay of conservative treatment of frozen shoulder.
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Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect.
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Manipulation or arthroscopic release under general anesthesia may avoid pain during the intervention; however, increased risk of humeral shaft fracture and failure of release of pathological tissue were reported.
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We consider intra-articular injection is a compromized way, from a practical point of veiw, to reduce the pain during physiotherapy.
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We hypothesize that, intra-articular injection with lidocaine before joint mobilization and stretch exercise, can make the patient pain-free during physiotherapy, and the effect of combined therapy is superior to physiotherapy alone in the treatment of frozen shoulder.
详细描述
A randomized controlled trial to compare the effect in treatment of frozen shoulder between combined intra-articular injection with lidocaine plus physiotherapy and physiotherapy alone.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed as unilateral frozen shoulder, with the definition as more than 50% loss of passive movement of the shoulder joint relative to the non-affected side, in one or more of the three movement direction (ie. abduction in the frontal plane, forward flexion in sagittal plane, or external rotation in 0 degree of abduction)
- •Duration of complaints of more than three months
- •Ability to complete questionnaires in Chinese
排除标准
- •History of shoulder fracture, dislocation, or trauma
- •History of Rheumatic arthritis, tumor, or other diseases in the shoulder joints
- •Receive intra-articular corticosteroid injection or manipulation therapy in shoulder joint in recent four weeks
- •Pregnancy or breast feeding
- •Allergic to lidocaine
结局指标
主要结局
Change from Baseline in range of motion at 3-months intervention
时间窗: baseline; 1 month; 2 months; 3 months
* Measured with a conventional goniometer by a physiotherapist, both active and passive range of motion * Including shoulder flexion, abduction, internal rotation, and external rotation * All measurements will be rounded off to the nearest five degrees
Change from Baseline in range of motion at 3 months post-intervention
时间窗: baseline; 1 and 3 months after completion
* Measured with a conventional goniometer by a physiotherapist, both active and passive range of motion * Including shoulder flexion, abduction, internal rotation, and external rotation * All measurements will be rounded off to the nearest five degrees
次要结局
- Visual analog scale (VAS)(baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion)
- Shoulder Rating Questionnaire (SRQ)(baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion)
- Shoulder Disability Questionnaire (SDQ)(baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion)
- 36-Item Short-form health survey (SF-36)(baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion)