The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Need for surgery
研究概览
简要总结
Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.
详细描述
There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )
- •Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
- •Symptom duration of minimum 3 months.
- •Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:
- •Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop & Veer, 2003)
- •Painful arc during active abduction (Ombregt, Bisschop & Veer, 2003)
- •Positive Neers sign (Neer, 1972 ; Tennent, Beach & Meyers, 2003)
- •Positive Jobes test (Jobe & Moynes, 1982 ; Tennent, Beach & Meyers, 2003)
- •Positive Hawkins-Kennedy impingement test (Hawkins & Kennedy, 1980)
排除标准
- •Shoulder pain due to trauma, e.g. fall.
- •Reduced ROM consistent with adhesive capsulitis/frozen shoulder
- •History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
- •Full thickness rupture of rotator cuff tendon
- •OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
- •Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
- •Subjects suffering from serious psychiatric illness.
- •Subjects unable to understand English or Norwegian.
- •Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.
结局指标
主要结局
Need for surgery
时间窗: 12 weeks (end of treatment) and 6 months post treatment
Dichotomised questionnaire yes or no
Shoulder function
时间窗: 4 weeks , 12 weeks and 6 months
Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.
Shoulder Pain
时间窗: 4 weeks , 12 weeks and 6 months
Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
Generic health status
时间窗: 12 weeks and 6 months
EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
次要结局
- Rotator cuff force(12 weeks ( end of treatment))
- Tendon thickness(12 weeks ( end of treatment ))
- Analgesics and corticosteroid injections(4 weeks , 12 weeks and 6 months)
- Patient global impression of change(4 weeks, 12 weeks & 6 months)
- Tendon pain pressure threshold(12 weeks ( end of treatment ))
研究者
Sturla Haslerud
Sturla Haslerud , PT , Msc Orthopedics & Reumatology , PhD candidate
Bergen University College