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临床试验/NCT01449448
NCT01449448撤回不适用

A Double-blind Randomized Controlled Trial Comparing the Effects of Subacromial Injection With Corticosteroid Versus NSAID in Patients With Shoulder Impingement Syndrome

Madigan Army Medical Center0 个研究点开始时间: 2000年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
UCLA Shoulder Rating Scale

研究概览

简要总结

Injection with corticosteroid is one of the most common non-operative interventions in the treatment of subacromial impingement; however, its use is limited by its potential side effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac. Thirty-two patients diagnosed with external shoulder impingement syndrome were included in this double-blinded randomized controlled clinical trial. Each patient was randomized into the Steroid group or NSAID group.

详细描述

After a single injection into the subacromial space, the patients were instructed to perform home physical therapy and follow-up in four weeks. Each patient was evaluated in terms of arc of motion, Visual Analog Scale and the UCLA Shoulder Rating Scale.

The outcome measures were taken at the preinjection state, immediately post injection, and at 4 weeks follow-up.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Shoulder pain characteristic of subacromial impingement syndrome with passive and/or active abduction in the 60-120 arc of motion (positive impingement sign)
  • Diagnosis of subacromial bursitis based on tenderness to palpation anterior/lateral to the acromion. Pain may be exacerbated with the shoulder held in internal rotation (positive Hawkins test)

排除标准

  • Age <18 years
  • Symptoms less than one month
  • Previous shoulder injections within the past 3 months
  • Evidence of os-acromiale or other confounding shoulder pathology on plain radiographs
  • Evidence of shoulder osteoarthritis
  • Full thickness rotator cuff tear evidenced by MRI, cuff weakness after lidocaine injection, or positive drop-arm sign
  • Systemic inflammatory condition
  • Pending litigation or work-related claims related to the shoulder
  • Previous shoulder surgery on the affected shoulder
  • Evidence of local infection
  • Evidence of adhesive capsulitis
  • Previous history of gastrointestinal ulcers or bleeding disorders
  • Evidence of shoulder instability

研究组 & 干预措施

NSAID

Experimental

Test Group: This group was given subacromial injections of Ketorolac.

干预措施: Ketorolac (Drug)

Steroid

Active Comparator

This group was given a subacromial injection triamcinolone.

干预措施: Triamcinolone (Drug)

结局指标

主要结局

UCLA Shoulder Rating Scale

时间窗: 4 Weeks

This scoring system consists of subjective assessments of pain, function and satisfaction, as well as objective measurements of active forward elevation and strength in forward flexion.

次要结局

  • Visual Analog Scale(4 Weeks)
  • Range of Motion(4 Weeks)

研究者

申办方类型
Fed
责任方
Sponsor

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