Effect of surgery on shoulder pain in patients not helped by other treatments
Official title: 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.
Run by Hvidovre University Hospital · NCT04644042 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre, Denmark) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | June 1, 2029 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT04644042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with subacromial impingement syndrome who have not improved after at least three months of non-operative treatment.
✕Probably not a fit
Patients with severe medical conditions, full-thickness rotator cuff tears, or other specific shoulder pathologies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown varying success with similar surgical approaches, but this specific combination of interventions is being tested for the first time.
Who can join: the full rules
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 it's running
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Hvidovre Univeristy Hospital
Hvidovre, Denmark, Denmark Recruiting
Study contacts
- Study coordinator: Adam Witten, MD
- Email: adam.witten.02@regionh.dk
- Phone: 004528780809
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Functional electrical stimulation plus shoulder exercises for older adults with rotator cuff pain
In older adults with rotator cuff–related shoulder pain, this study tests whether adding functional electrical stimulation to a shoulder exercise program improves muscle coordination and reduces impingement compared with exercises alone.
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This trial tests whether adding Mulligan mobilization or proprioceptive neuromuscular facilitation to standard physical therapy helps adults with Subacromial Impingement Syndrome.
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Blood Flow Restriction Training vs Pilates for Subacromial Impingement
In people with subacromial impingement, this study tests whether adding low-load blood flow restriction training or Pilates to standard therapy helps reduce pain and improve shoulder function.
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This trial will test whether supervised physiotherapy or a home exercise program works better for adults aged 30–65 with unilateral subacromial impingement syndrome.
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This trial will test whether virtual reality–based exercises or Mulligan mobilization, each added to exercise therapy, better improve shoulder posture and function in adults aged 30–50 with subacromial impingement syndrome.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.