Operative Versus Non-operative Management of Subacromial Impingement

Not Applicable

Active, not recruiting

• Conditions: Subacromial Impingement Syndrome
• Interventions: Procedure: Physiotherapy; Procedure: Acromioplasty

• Registration Number: NCT00637013
• Lead Sponsor: Central Finland Hospital District

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-17
• Study Start: 2008-06
• Primary Completion: 2017-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-11
• Last Update Posted: 2024-02-13
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in pain (VAS) and objective shoulder function (Constant score)	24 months after intervention	VAS (0 to 100 mm), Constant score (0 to 100 points)

Secondary Outcome Measures

Name	Time	Method
Change in pain (VAS) and objective shoulder function (Constant score)	5 years after uintervention	VAS (0 to 100 mm), Constant score (0 to 100 points)

Trial Locations

Locations (3)

University of Helsinki; 🇫🇮 Helsinki, Finland

Central Finland Health District; 🇫🇮 Jyväskylä, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland