Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

Study Overview
=================
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 Description
-----------------
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.

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

Conditions
-----------------
Shoulder Impingement Syndrome

Intervention / Treatment
-----------------
* Procedure: acromioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: glenohumeral or acromioclavicular arthritis glenohumeral instability total rupture of the rotator cuff cervical syndrome adhesive capsulitis neuropathy of the shoulder region

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: acromioplasty|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at night |  |  | 
| disability |  |  | 
| ability to work |  |  | 
| ranges of motion |  |  | 
| cost-effectiveness |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subacromial, impingement, acromioplasty, physiotherapy