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临床试验/NCT00349648
NCT00349648Unknown不适用

Conservative or Operative Treatment for the Shoulder Impingement Syndrome? A Randomized Controlled Trial of 140 Patients Followed Up for Two Years.

Kanta-Häme Central Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2001年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
2
主要终点
shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization

研究概览

简要总结

Study hypothesis: The impingement syndrome of the rotator cuff is a common cause of shoulder pain for which the most effective treatment is unknown. Steroid injections and anti-inflammatory analgetics are considered as effective methods. Physiotherapy and acromioplasty are commonly used treatments.

Hypothesis: Arthroscopy and acromioplasty in addition to conservative treatment is equally effective as conservative treatment alone for shoulder impingement syndrome.

详细描述

The aim of this study was to examine the effectiveness of arthroscopic acromioplasty in the treatment of the shoulder impingement syndrome. Nonoperative treatment consisted of information given by a trained physiotherapist. The patients were supervised with a progressive programme to improve the mobility and muscle strength of the shoulder region which was regularly controlled. The exercises aimed at strengthening the stabilising muscles of the glenohumeral joint (m. trapezius, m. deltoides, m. supraspinatus and m. infraspinatus) and activating the decompressive muscles of the the subacromial space (m. teres major and minor, m. subscapularis). The programme lasted for three months. In addition the patients were given advice for daily home exercise.

In the surgical group the patients underwent an arthroscopic examination and acromioplasty done by one experienced orthopaedic specialist. Postoperatively the patients received similar physiotherapeutical information and training programme than in the conservative treatment group.

The follow-up evaluations were performed at 3, 6 and 12 months from the beginning of each treatment in addition at 24 months counted from the randomization. A trained research physiotherapist who was blinded to the treatment group and had not been involved in their treatment performed a standardized assessment of all patients. The range of motion, muscle strengths and Neer´s tests were recorded. At each evaluation the patients completed a structured questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • a positive clinical Neer's test
  • shoulder pain resistant to rest
  • shoulder pain resistant to anti-inflammatory drugs
  • shoulder pain resistant to subacromial steroid injections
  • shoulder pain resistant to ordinary physiotherapy with a minimum history of three months

排除标准

  • glenohumeral or acromioclavicular arthritis
  • glenohumeral instability
  • total rupture of the rotator cuff
  • cervical syndrome
  • adhesive capsulitis
  • neuropathy of the shoulder region

结局指标

主要结局

shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization

次要结局

  • pain at night
  • disability
  • ability to work
  • ranges of motion
  • cost-effectiveness

研究者

发起方
Kanta-Häme Central Hospital
申办方类型
Other Gov

研究点 (2)

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