Operative Versus Non-operative Management of Subacromial Impingement

Central Finland Hospital District

Status: Active, not recruiting

Conditions: Subacromial Impingement Syndrome

Treatments: Procedure: Physiotherapy; Procedure: Acromioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00637013

B07103

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Acromioplasty

Active Comparator group

Description:

Acromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment

Treatment:

Procedure: Acromioplasty

Physiotherapy

Active Comparator group

Description:

Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment

Treatment:

Procedure: Physiotherapy