Clinical trial NCT04644042: The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The trial is designed as a patient and assessor-blinded, randomized, controlled trial with two parallel groups. Participants are randomized 1:1 to either ASAD and glenohumeral arthroscopy (intervention group) or glenohumeral arthroscopy alone (control group). The two groups are subscribed identical postoperative rehabilitation consisting of 3 months physiotherapy in a municipally setting. The primary endpoint is the Shoulder Pain and Disability Index (SPADI) 12 months after surgical intervention. The study will adhere to the CONSORT guidelines.

All participants will be recruited consecutively from the outpatient clinic, Arthroscopic Center, Copenhagen University Hospital, Hvidovre. Consultant orthopedic surgeons will conduct the initial eligibility screening as part of their consultation. Eligible participants will be provided with thorough verbal and written information about the trial and their right to withdraw at any time. Patients given their written, informed consent to participate in the trial, will receive scheduled appointments for the baseline examination.

Eligibility 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

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 12 months after surgical intervention.
Secondary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 24 months
measure: Oxford Shoulder Score
timeFrame: 24 months
measure: Patient Satisfaction
timeFrame: 12 months
measure: Active Shoulder Abduction Range Of Motion (AROM)
timeFrame: 12 months
measure: Pain during Active Shoulder Abduction Range Of Motion (NPRS-AROM)
timeFrame: 12 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Univeristy Hospital
Study officials:
affiliation: Sports Orthopedic Research Center - Copenhagen (SORC-C), Hvidovre Hospital
name: Kristoffer Barfod, MD
role: STUDY_DIRECTOR
References: