The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
- Conditions
- Subacromial Impingement Syndrome
- Interventions
- Procedure: Glenohumeral arthroscopy + Arthroscopic Subacromial DecompressionProcedure: Glenohumeral arthroscopy + lateral skin incision
- Registration Number
- NCT04644042
- Lead Sponsor
- Hvidovre University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glenohumeral arthroscopy and arthroscopic subacromial decompression Glenohumeral arthroscopy + 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. Glenohumeral arthroscopy and skin incision Glenohumeral arthroscopy + lateral 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.
- Primary Outcome Measures
Name Time Method Shoulder Pain and Disability Index (SPADI) 12 months after surgical intervention. The primary outcome is SPADI 12 months after surgical intervention.
- Secondary Outcome Measures
Name Time Method Shoulder Pain and Disability Index (SPADI) 24 months SPADI is registered as a secondary outcome 3, 6 and 24 months after surgical intervention.
Oxford Shoulder Score 24 months Oxford Shoulder Score is registered 3, 6, 12 and 24 months after surgical intervention.
Patient Satisfaction 12 months Patient satisfaction will be assessed using three questions:
1. "How are the problems related to your shoulder now, compared with before surgery?" (response options: no problems at all, much better, slightly better, no change, slightly worse, much worse)
2. "Overall, how pleased have you been with the result of your surgery so far?" (response options: very pleased, fairly pleased, not very pleased, very disappointed)
3. "If you could go back in time, would you still choose to have the shoulder operation?" (response options: yes, no, not sure).Active Shoulder Abduction Range Of Motion (AROM) 12 months Active Shoulder Abduction Range Of Motion is registered at 3 and 12 months after surgical intervention.
Pain during Active Shoulder Abduction Range Of Motion (NPRS-AROM) 12 months Pain during active shoulder abduction range of motion is evaluated using the numeric pain rating scale (NPRS) at 3 and 12 months after surgical intervention.
Trial Locations
- Locations (1)
Hvidovre Univeristy Hospital
🇩🇰Hvidovre, Denmark