Arthroscopic Decompression Versus Diagnostic Arthroscopy Without Subacromial Decompression Versus Supervised Exercise Therapy in Treatment of Subacromial Impingement Syndrome. A Blinded Randomized Controlled Trail.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Pain at rest
研究概览
简要总结
pShoulder impingement syndrome is common and number of operations done per year is growing. The aim of this study is to compare the value of arthroscopic subacromial decompression (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The results of treatment are measured at 3 months, 6 months, 12 months, 24 months, 5 years and 10 years. Primary outcome measures are pain at rest and activity (VASs) and secondary outcomes are functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change , quality of life assessment (SF-36 and 15D) and costs. At 10 year follow-up, MRI imaging is obtained and the findings compared to baseline imaging.
详细描述
Applicant information:
Name: Mika Paavola, MD, PhD Address: Helsinki University Central Hospital, Töölö Hospital, Topeliuksenkatu 5, P.O. Box 266, FIN-00029 HUS, Finland Tel: +358 50 523 8382 Fax: +358 9 471 87481 Email: mika.paavola@hus.fi
Trial record details:
Protocol / serial number: N/A Title: Arthroscopic decompression versus diagnostic arthroscopy without subacromial decompression versus supervised exercise therapy in treatment of subacromial impingement syndrome. A blinded randomized controlled trail.
Acronym: N/A Study hypothesis: Operative and diagnostic arthroscopy is equally effective as conservative treatment (supervised exercise therapy) alone for subacromial impingement syndrome.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the first phase orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of Helsinki University Hospital, (either Töölö Hospital or Jorvi Hospital) or District Hospital of Tampere (Hatanpää Hospital) and fulfill the following inclusion criteria:
- •Subjects are 35 to 65 years of age female or male and have a characteristic history and symptoms of subacromial impingement syndrome at least 3 months.
- •Symptoms have no relieved with appropriate conservative treatment (i.e. physiotherapy, NSAIDs and subacromial corticosteroid injection).
- •They have clinical findings of impingement syndrome; painful arc sign and pain in shoulder abduction, positive findings in two of three isometric shoulder abduction tests (0 degree, 30 degree and external rotation), and positive subacromial injection test.
排除标准
- •Previous surgery of affected shoulder
- •Symptomatic osteoarthrosis of acromio-clavicular joint
- •Full thickness rotator cuff tear based on clinical findings and MRI
- •Long-term cervical syndrome
- •Instability of shoulder
- •Reluctance to participate in any study groups (i.e. any treatment options of the study)
- •Reduced co-operation (drug or alcohol abuse, mental illness)
研究组 & 干预措施
Arthroscopic acromioplasty
Arthroscopic acromioplasty
干预措施: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation) (Procedure)
Sham surgery
Shoulder arthroscopy without active treatment and subacromial arthroscopy without bursectomy, decompression or other active interventions
干预措施: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation) (Procedure)
Conservative treatment
Standardized exercise rehabilitation (supervised by physiotherapist)
干预措施: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation) (Procedure)
结局指标
主要结局
Pain at rest
时间窗: 2 years (primary)
Assessed with 10-cm visual analog scales (VASs).
Pain during activity
时间窗: 2 years (primary)
Assessed with 10-cm visual analog scales (VASs).
次要结局
- SF-36 and 15D(2 years (primary))
- Constant score and Simple Shoulder test(2 years (primary))
- Costs(2 years (primary))
- global assessment of change,(2 years (primary))
研究者
Mika Paavola
MD, PhD
University of Helsinki