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临床试验/NCT03120923
NCT03120923已完成4 期

A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials

Ramathibodi Hospital0 个研究点目标入组 52 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
52
主要终点
VAS

研究概览

简要总结

This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome

详细描述

Patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10mL total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4mL total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). Evaluations using a visual analog scale (VAS) for pain during motion, and the Western Ontario Rotator Cuff Index (WORC) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • participants with clinically diagnosed the rotator cuff impingement
  • participants aged 20 years and older
  • at least 1 month's duration
  • pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain)

排除标准

  • patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion >30° in ≥2 planes of movement)
  • previous trauma history at currently affected shoulder
  • previous corticosteroid injection history at the affected shoulder
  • abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs
  • use of medication such as antiplatelet agent or anticoagulation.

研究组 & 干预措施

Lidocaine 3 cc & Triamcinolone Acetonide

Experimental

干预措施: Lidocaine 3 cc (Drug)

Lidocaine 3 cc & Triamcinolone Acetonide

Experimental

干预措施: Triamcinolone Acetonide (Drug)

Lidocaine 9cc & Triamcinolone Acetonide

Active Comparator

干预措施: Lidocaine 9 cc (Drug)

Lidocaine 9cc & Triamcinolone Acetonide

Active Comparator

干预措施: Triamcinolone Acetonide (Drug)

结局指标

主要结局

VAS

时间窗: 8 weeks

Visual analog score

次要结局

  • Adverse reaction(8 weeks)
  • WORC(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jatupon Kongtharvonskul

Dr

Khon Kaen University

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