Actively Recruiting
The Effect of Arthroscopic Subacromial Decompression in Patients With Subacromial Impingement Syndrome Who Are Non-responders to Non-operative Treatment. A Double-blinded, Randomized, Controlled Trial.
Led by Hvidovre University Hospital · Updated on 2025-04-30
160
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding arthroscopic subacromial decompression (ASAD) to glenohumeral arthroscopy improves outcomes for patients with subacromial impingement syndrome (SIS) who have not responded to non-operative treatment. This trial is a patient- and assessor-blinded, randomized controlled study designed to compare these two surgical approaches and their effects on patient-reported shoulder pain and disability after 12 months. Participants are randomly assigned to one of two groups. The intervention group receives glenohumeral arthroscopy combined with ASAD, which involves decompressing the subacromial space by removing inflamed tissue and bone spurs. The control group receives glenohumeral arthroscopy alone, with a small skin incision to mimic the ASAD procedure for blinding purposes. Both groups follow the same postoperative care including discharge with an arm sling and a three-month supervised physiotherapy program with progressive exercises. During the study, participants will undergo scheduled assessments including the Shoulder Pain and Disability Index (SPADI) at 12 and 24 months, Oxford Shoulder Score at 24 months, and measurements of shoulder motion and pain at 12 months. Researchers will monitor patient satisfaction and shoulder function over time. The trial follows CONSORT guidelines and ensures participants can withdraw at any time. The total participation duration includes baseline examination and follow-up evaluations up to 24 months.
CONDITIONS
Brief Title
The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of subacromial impingement syndrome confirmed by consultant plus at least 3 positive tests from Hawkin's, Neer's, Jobe's, Painful arc, and external rotation resistance test
- Positive response to subacromial injection test
- Shoulder pain with gradual onset
- Considered a surgical candidate by an orthopedic shoulder specialist
- Symptoms lasting at least 6 months
- Completed at least 3 months of supervised shoulder training
- No improvement in symptoms for at least 3 months
- Expected ability to attend rehabilitation and follow-up examinations
You will not qualify if you...
- Terminal or severe medical illness (ASA score ≥ 4), systemic musculoskeletal or inflammatory joint diseases, symptomatic cervical spine pathology, or thoracic outlet syndrome
- Full-thickness rotator cuff tear, calcified tendonitis, labral tear, frozen shoulder, biceps tendon pathology, acromioclavicular or glenohumeral osteoarthrosis, or other shoulder pathologies
- Previous surgery or radiotherapy on the affected shoulder
- Pregnancy
- Ongoing workers compensation or job rehabilitation case
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical day plus immediate recovery
Participants undergo either glenohumeral arthroscopy with arthroscopic subacromial decompression or glenohumeral arthroscopy with a skin incision. After surgery, participants are discharged with an arm sling and begin rehabilitation.
1 surgical visit (in-person)
Duration - 3 months
Participants follow a rehabilitation program consisting of 3 months of physiotherapy in a municipally setting with progressive exercises to guide recovery.
Regular physiotherapy visits over 3 months
Duration - Up to 24 months after surgery
Participants have follow-up assessments to evaluate shoulder pain, disability, satisfaction, and shoulder function up to 24 months after surgery.
1 to 2 visits depending on assessment schedule
Trial Site Locations
Total: 1 location
1
Hvidovre Univeristy Hospital
Hvidovre, Denmark, Denmark, 2650
Actively Recruiting
Research Team
A
Adam Witten, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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