Operative Versus Non-operative Management of Subacromial Impingement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Operative or Conservative Treatment for Subacromial Impingement Syndrome?

NCT00428870

Subacromial Impingement Syndrome

UNKNOWN NA

Operative Versus Non-operative Management of Rotator Cuff Tear

NCT00695981

Rotator Cuff Tear

ACTIVE_NOT_RECRUITING NA

Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises

NCT01037673

Subacromial Impingement Syndrome

COMPLETED NA

Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

NCT00632996

Shoulder Impingement Syndrome

COMPLETED PHASE2

Conservative or Operative Treatment for the Shoulder Impingement Syndrome?

NCT00349648

Shoulder Impingement Syndrome

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subacromial Impingement Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acromioplasty

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

Group Type ACTIVE_COMPARATOR

Acromioplasty

Intervention Type PROCEDURE

Arthroscopic or open acromioplasty

Physiotherapy

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

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type PROCEDURE

Physiotherapy according to a standardized protocol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acromioplasty

Arthroscopic or open acromioplasty

Intervention Type PROCEDURE

Physiotherapy

Physiotherapy according to a standardized protocol

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Subacromial decompression Physical therapy Non-operative treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No