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临床试验/NCT05266391
NCT05266391已完成不适用

Comparison of Clinical Results of Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections in Subacromial Impingement Syndrome

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Visual analogue scale (VAS)

研究概览

简要总结

Since pain is usually accompanied by a substantial effect on daily life that results in the extensive use of healthcare resources. In subacromial impingement syndrome, shoulder pain affects the quality of life negatively by affecting upper extremity functions and interrupting night sleep. It is very important to control the pain in order to reduce the loss to the labor force and prevent the pain from becoming chronic. Various physical treatment methods such as ultrasound, hot pack, transcutaneous electrical nerve stimulation, etc., and injections or medical agents are recommended. This study aimed to compare the effects of ultrasound (US)-guided in comparison to landmark guided subacromial corticosteroids injection on shoulder range of motion (ROM), pain, and functional status in patients with subacromial impingement syndrome (SAIS).

详细描述

Patients were assigned to two groups: Group-1 included patients who received US-guided subacromial corticosteroid injections; Group-2 included patients who underwent blind subacromial corticosteroid injections. The primary Outcome Measure was a Visual analog scale. Secondary Outcome Measures were Shoulder joint range of motion (ROM), Shoulder Pain and Disability Index (SPADI), The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Shoulder posterolateral pain that increased with shoulder abduction,
  • Restriction of the shoulder passive and active range of motion (ROM),
  • Patients with positive Neer and Hawkins impingement test,
  • Patients with SAIS whose diagnosis was confirmed by magnetic resonance imaging (MRI), and
  • Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).

排除标准

  • Patients who received corticosteroid, local anesthetic, hyaluronic acid, and platelet-rich plasma injections in the shoulder in the last one year,
  • patients who had previous history of surgery or fracture in their thorax, neck, upper extremity or shoulder joint,
  • patients with a rheumatological, cognitive or psychiatric, central or peripheral neurological disease (stroke, spinal cord injury, brachial plexus injury, etc.),
  • patients whose MRI presented a partial or complete rotator cuff tear, calcific tendinitis or labral tear.

结局指标

主要结局

Visual analogue scale (VAS)

时间窗: Change from baseline visual analogue scale score at 1 month

It is a scale scored from 0 to 10 to evaluate the severity of pain. Patients are asked to rate the pain they feel as '0' for no pain and '10' for the most severe pain they have encountered in their life

次要结局

  • Shoulder Pain and Disability Index (SPADI)(Change from baseline Shoulder Pain and Disability Index at 1 month)
  • Shoulder joint range of motion (ROM)(Change from baseline Shoulder joint range of motion at 1 month)
  • The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)(Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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