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.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To investigate if glenohumeral arthroscopy and arthroscopic subacromial decompression is more effective than glenohumeral arthroscopy alone in improving patient-reported outcome at 12 months in patients with subacromial impingement syndrome (SIS) who are non-responders to non-operative treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Hvidovre Univeristy Hospital
RECRUITING
Hvidovre
Contact Information
Primary
Adam Witten, MD
adam.witten.02@regionh.dk
004528780809
Time Frame
Start Date:2021-09-01
Estimated Completion Date:2029-06-01
Participants
Target number of participants:160
Treatments
Experimental: Glenohumeral arthroscopy and arthroscopic subacromial decompression
The intervention group will receive a glenohumeral arthroscopy and ASAD. Participants are discharged with an arm sling and referred to 3 months physiotherapy in a municipally setting. Participants are given a rehabilitation program containing progressive exercises to guide the rehabilitation.
Active_comparator: Glenohumeral arthroscopy and skin incision
The control group will receive a glenohumeral arthroscopy, but no treatment concerning the subacromial structures. To allow for the best possible blinding, a 7-10 mm incision, mimicking the one used for ASAD, is performed on the lateral side of the arm 2-3 distal to the acromion. Participants are discharged with an arm sling and referred to 3 months physiotherapy in a municipally setting. Participants are given a rehabilitation program containing progressive exercises to guide the rehabilitation.