Clinical Trial: Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Central Hospital of Kanta-Hame

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Central Hospital of Kanta-Hame

Dates:
Date Received: July 6, 2006
Date Started: March 2001
Date Completion: July 2006
Last Updated: July 6, 2006
Last Verified: July 2006