Operative Versus Non-operative Management of Subacromial Impingement

Study Overview
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Brief Summary
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The study aims at determining the effectiveness and cost-effectiveness of surgical management of subacromial impingement (including partial tears) compared to conservative treatment. The research setting is prospective, randomised, and controlled. The aim of the study is to search out evidence based data of indications for subacromial decompression. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when subacromial impingement is suspected. The investigators hypothesise that there are subgroups of patients suffering from subacromial impingement that benefit from surgery whereas other subgroups are best treated conservatively.

Detailed Description
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Subgroup analysis: age sex duration of symptoms presence of trauma before symptoms presence of partial tear degenerative findings other findings in MRI or arthroscopy type of operation co-morbidities occupation pain (VAS) objective shoulder function activities of daily living

Official Title
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The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement

Conditions
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Subacromial Impingement Syndrome

Intervention / Treatment
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* Procedure: Acromioplasty
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 35 years old duration of symptoms at least three months despite non-operative treatment accepts both treatment options (operative and physical therapy) must have pain in abduction of the shoulder must have painful arc must have pain in two of the three isometric tests (0 and 30 degrees of abduction, or external rotation) a positive result in the impingement test (a subacromial injection of lidocaine reduces pain) Exclusion Criteria: previous shoulder operations too high risk for operation any disease or social problem reducing the ability to co-operate rheumatoid arthritis severe arthrosis of the glenohumeral or acromioclavicular joint a full-thickness rotator cuff tear in MRI arthrography a progressive malign disease adhesive capsulitis high-energy trauma before symptoms cervical syndrome shoulder instability

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acromioplasty<br>Acromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment | Procedure: Acromioplasty<br>* Arthroscopic or open acromioplasty<br>* Other names: Subacromial decompression;|
| Active Comparator: Physiotherapy<br>Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment | Procedure: Physiotherapy<br>* Physiotherapy according to a standardized protocol<br>* Other names: Non-operative treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 24 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 3 months after intervention | 
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 6 months after intervention | 
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 12 months after intervention | 
| Change in pain (VAS) and objective shoulder function (Constant score) | VAS (0 to 100 mm), Constant score (0 to 100 points) | 5 years after uintervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Subacromial impingement, RCT, Effectiveness, Cost-effectiveness