Effect of surgery on shoulder pain in patients not helped by other treatments
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.
This study is testing if adding a specific shoulder surgery can help people with shoulder pain who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre, Denmark) |
| Trial ID | NCT04644042 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether adding arthroscopic subacromial decompression to glenohumeral arthroscopy improves outcomes for patients with subacromial impingement syndrome who have not responded to non-operative treatments. It is a randomized, controlled trial with two groups: one receiving both surgeries and the other receiving only glenohumeral arthroscopy. Participants will undergo a standardized rehabilitation program post-surgery, and their progress will be assessed using the Shoulder Pain and Disability Index at 12 months. The study follows CONSORT guidelines to ensure rigorous methodology.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with subacromial impingement syndrome who have not improved after at least three months of non-operative treatment.
Not a fit: Patients with severe medical conditions, full-thickness rotator cuff tears, or other specific shoulder pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective surgical option for patients suffering from persistent shoulder pain.
How similar studies have performed: Previous studies have shown varying success with similar surgical approaches, but this specific combination of interventions is being tested for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * SIS diagnosis (Consultant's clinical diagnosis of SIS + at least 3 out of 5 positive tests from the following: Hawkin's, Neer's, Jobe's, Painful arc and external rotation resistance test) * Positive subacromial injection test * Insidious onset of shoulder pain * Considered a surgical candidate by an orthopedic shoulder specialist. * Symptoms for at least 6 months * Completion of at least 3 months supervised shoulder training * No improvement in symptoms for at least 3 months * The patient must be expected to be able to attend rehabilitation and post-examinations. Exclusion Criteria: * Terminal illness or severe medical illness (ASA score higher than or equal to 4), systemic musculoskeletal disease, inflammatory joint disease (e.g. rheumatoid arthritis), symptomatic cervical spine pathology or thoracic outlet syndrome. * Full-thickness rotator cuff tear, calcified tendonitis, labral tear, frozen shoulder, biceps tendon pathology, acromioclavicular osteoarthrosis, glenohumeral osteoarthrosis or other concomitant shoulder pathology. * Previous surgery or radiotherapy on the affected shoulder. * Pregnancy * Ongoing workers compensation case or job rehabilitation process
Where this trial is running
Hvidovre, Denmark
- Hvidovre Univeristy Hospital — Hvidovre, Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Adam Witten, MD
- Email: adam.witten.02@regionh.dk
- Phone: 004528780809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.