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临床试验/NCT03677895
NCT03677895Unknown不适用

What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年10月8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
入组人数
200
试验地点
1
主要终点
constant shoulder score

研究概览

简要总结

To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients

详细描述

Objective

To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients and also investigate the factors associated with clinically important improvement after subdeltoid hyaluronic acid for rotator cuff disorder.

Design: Prospective, longitudinal comparison study.

Participants: Patients with rotator cuff disease

Intervention: Three subacromial injection with hyaluronic acid with 2 week-interval.

Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 4 and post-treatment at week 12.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

outcome assessor does not know the rotator cuff condition of patients

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • presence of another medical or psychological condition, including cancer, rheumatoid arthritis, endocrine disease (i.e., diabetes), major depression, or schizophrenia;
  • previous major trauma history at currently affected shoulder; 3 primary osteoarthritis of the glenohumeral joint in a simple radiograph; 4previous injection history at the affected shoulder within 3 months

研究组 & 干预措施

patients with rotator cuff disorders

Experimental

patients with rotator cuff disorders, including impingment, rotator cuff disorders and rotator cuff tear receiving hyaluronic acid injection over subacromial bursa

干预措施: Hyaluronic Acid (Drug)

结局指标

主要结局

constant shoulder score

时间窗: 12 weeks

the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength

次要结局

  • pain intensity measured by visual analog scale(0, 6, 12 weeks)
  • Shoulder Pain And disability index(0, 6, 12 weeks)
  • glenohumeral joint range of motion(0, 6, 12 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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