Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit to Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Shoulder Pain And disability index
研究概览
简要总结
This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus hydrodilatation with steroid with axillary nerve injection for treating patients with 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 rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.
Design: a prospective, single-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided hydrodilatation with steroid via posterior approach) and group 2 (ultrasound guided hydrodilatation with steroid via posterior approach as well as axillary nerve injection). 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, and 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 (Investigator, 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 (to prevent the inclusion of patients with secondary AC),
- •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
- •intra-articular 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 and axillary nerve injection
patient received ultrasound-guided steroid hydrodilatation via posterior recess
干预措施: steroid hydrodilatation (Drug)
hydrodilatation and axillary nerve injection
patient received ultrasound-guided steroid hydrodilatation via posterior recess
干预措施: axillary nerve injection (Drug)
hydrodilatation only
patient received ultrasound-guided steroid hydrodilatation only
干预措施: steroid hydrodilatation (Drug)
结局指标
主要结局
Shoulder Pain And disability index
时间窗: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.function. The score is divided into four sections: pain, activity of daily living, ROM and strength
次要结局
- pain intensity(Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline)
- glenohumeral joint range of motion(Change at baseline, 6 weeks, 12 weeks)