Overview

This trial is active, not recruiting.

Condition subacromial impingement syndrome
Treatments acromioplasty, physiotherapy
Sponsor Central Finland Hospital District
Collaborator Academy of Finland
Start date June 2008
End date December 2017
Trial size 100 participants
Trial identifier NCT00637013, B07103

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Acromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
acromioplasty Subacromial decompression
Arthroscopic or open acromioplasty
(Active Comparator)
Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
physiotherapy Physical therapy
Physiotherapy according to a standardized protocol

Primary Outcomes

Measure
Change in pain (VAS) and objective shoulder function (Constant score)
time frame: 24 months after intervention

Secondary Outcomes

Measure
Change in pain (VAS) and objective shoulder function (Constant score)
time frame: 3 months after intervention
Change in pain (VAS) and objective shoulder function (Constant score)
time frame: 6 months after intervention
Change in pain (VAS) and objective shoulder function (Constant score)
time frame: 12 months after intervention
Change in pain (VAS) and objective shoulder function (Constant score)
time frame: 5 years after uintervention

Eligibility Criteria

Male or female participants at least 35 years old.

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

Additional Information

Official title The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement
Principal investigator Ilkka Kiviranta, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Central Finland Hospital District.