Clinical trial Recruiting at 1 site Interventional Ages 18 to 99

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.

More Subacromial Impingement Syndrome trials

Quick facts

Study typeInterventional
Ages18 Years to 99 Years
SexAll
Enrollment160 (estimated)
SponsorHvidovre University Hospital
Academic / other
Locations1 site (Hvidovre, Denmark)
StatusRecruiting
StartedSeptember 1, 2021
Main results expectedDecember 31, 2028
Study endsJune 1, 2029
Registry record updatedApril 30, 2025
Trial IDNCT04644042 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

  • Hvidovre Univeristy Hospital
    Hvidovre, Denmark, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.