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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression (Procedure)
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.
干预措施: Glenohumeral arthroscopy + lateral skin incision (Procedure)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: 12 months after surgical intervention.
The primary outcome is SPADI 12 months after surgical intervention.
次要结局
- Oxford Shoulder Score(24 months)
- Shoulder Pain and Disability Index (SPADI)(24 months)
- Patient Satisfaction(12 months)
- Active Shoulder Abduction Range Of Motion (AROM)(12 months)
- Pain during Active Shoulder Abduction Range Of Motion (NPRS-AROM)(12 months)
研究者
Adam Witten
MD
Hvidovre University Hospital