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Operative Versus Non-operative Management of Subacromial Impingement

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00637013
Enrollment
100
Registered
2008-03-17
Start date
2008-06-30
Completion date
2027-01-31
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacromial Impingement Syndrome

Keywords

Subacromial impingement, Shoulder, RCT, Effectiveness, Cost-effectiveness

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

Interventions

PROCEDUREAcromioplasty

Arthroscopic or open acromioplasty

PROCEDUREPhysiotherapy

Physiotherapy according to a standardized protocol

Sponsors

Academy of Finland
CollaboratorOTHER
Oulu University Hospital
CollaboratorOTHER
Central Finland Hospital District
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain (VAS) and objective shoulder function (Constant score)24 months after interventionVAS (0 to 100 mm), Constant score (0 to 100 points)

Secondary

MeasureTime frameDescription
Change in pain (VAS) and objective shoulder function (Constant score)3 months after interventionVAS (0 to 100 mm), Constant score (0 to 100 points)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026