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临床试验/NCT03678038
NCT03678038已完成不适用

Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年9月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
64
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 rotator interval approach 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 rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). 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, 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
Single (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

入选标准

  • Diagnosis of frozen shoulder by physical examination and ultrasonography

排除标准

  • other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,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 xylocaine or corticosteroid
  • pregnancy or lactation;
  • received injection into the affected shoulder during the preceding 3 months
  • history of surgeries on the affected shoulders
  • Secondary frozen shoulder

研究组 & 干预措施

rotator interval injection

Experimental

patient received ultrasound-guided steroid injection via rotator interval

干预措施: Triamcinolone (Shincort) injection to rotator interval (Drug)

posterior recess injection

Active Comparator

patient received ultrasound-guided steroid injection via posterior recess

干预措施: Triamcinolone (Shincort) injection to posterior glenuhumeral recess (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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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