Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Shoulder Pain And Disability Index (SPADI)
研究概览
简要总结
The aim of this study is therefore to examine the clinical effectiveness and provide an economic analysis of individual versus group physiotherapy, following corticosteroid injection, for management of Subacromial Impingement (SAI) of the shoulder.
详细描述
This trial was a single blind, randomised, equivalence trial comparing rotator cuff rehabilitation classes with traditional individual physiotherapy in subacromial impingement of the shoulder. A total of 200 patients were planned to be recruited from patients with painful shoulder referred to the Ulster Community and Hospitals Trust and community physiotherapy at the Ulster, Ards and Bangor sites or injection clinics at the Ulster Hospital. Local General Practitioners were also informed of the study and invited to refer appropriate patients.
Intervention - Triamcinolone 40 mg (1 ml) and 6 weekly rotator cuff rehabilitation classes Control - Triamcinolone 40 mg (1 ml) and routine physiotherapy 6 sessions weekly for 6 weeks
The injection technique involving a lateral approach to the subacromial space was used. An interval of between 1 and 3 weeks was allowed between injection and commencement of classes or physiotherapy.
Classes were planned to be run by a rotating group of physiotherapists with at least 1 year of musculoskeletal outpatient's experience. They were to receive instruction on the protocol to use in the classes. Classes were to consist of six 30 min sessions on a weekly basis. A minimum of 5 and maximum of 10 participants were to attend. Advice was to be given on the nature of the condition. Subjects were to be instructed and supervised in exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises. Subjects were to be introduced to ongoing classes as they are recruited to the trial.
Six sessions of routine physiotherapy at weekly intervals were to be undertaken. Treatment was to be based on evidence-based guidelines for the treatment of shoulder impingement (Evidence-based clinical guidelines for the diagnosis, assessment and physiotherapy management of shoulder impingement syndrome Chartered Society of Physiotherapists 2005) and consist of mobilisation techniques and supervised exercises and stretches. A therapist with at least 1 year of musculoskeletal outpatients experience was to provide treatments.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Off site randomisation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral shoulder pain of more than 4 weeks duration and a Shoulder Pain and Disability Index (SPADI) score of >= 30 as this represents significant disability. Shoulder pain is defined as pain in the shoulder region, including the upper arm, elicited by active or passive shoulder movement. The diagnosis of "subacromial pain" is defined by range as no limitation in passive range of movement or restriction of passive range of movement mainly in abduction rather than external rotation.
排除标准
- •inability to give informed consent
- •physiotherapy or injection treatment for current shoulder pain in previous 3 months
- •blood coagulation disorders
- •bilateral shoulder pain
- •evidence of systemic infection
- •abnormal shoulder X-ray defined as significant glenohumeral or subacromial joint space narrowing suggesting osteoarthritis of glenohumeral joint or complete rotator cuff rupture,
- •evidence of rotator cuff tear, tested by external rotation lag sign, drop sign, internal rotation lag sign and static muscle resistance in external rotation, internal rotation and abduction,
- •history of significant trauma to the shoulder,
- •inflammatory joint disease,
- •history of cerebrovascular accident,
- •allergy or contraindication to Triamcinolone/contraindication to injection.
- •evidence of referred pain from cervical spine disease.
- •pregnancy or breast feeding
- •patients whose first language is not English
研究组 & 干预措施
Group Physiotherapy
1 class per week for 6 weeks (30 min length) aiming for 5-10 participants per class. Classes included advice on the nature of the condition and exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises
干预措施: Rotator cuff rehabilitation classes (Other)
Group Physiotherapy
1 class per week for 6 weeks (30 min length) aiming for 5-10 participants per class. Classes included advice on the nature of the condition and exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises
干预措施: Triamcinolone Injection (Drug)
Routine Physiotherapy
Individual physiotherapy sessions: 6 sessions weekly (30 min) for 6 weeks. Treatment was based on evidence-based guidelines for the treatment of shoulder impingement (CSP 2005) and consisted of mobilisation techniques, supervised exercises and stretches.
干预措施: Individual Physiotherapy (Other)
Routine Physiotherapy
Individual physiotherapy sessions: 6 sessions weekly (30 min) for 6 weeks. Treatment was based on evidence-based guidelines for the treatment of shoulder impingement (CSP 2005) and consisted of mobilisation techniques, supervised exercises and stretches.
干预措施: Triamcinolone Injection (Drug)
结局指标
主要结局
Shoulder Pain And Disability Index (SPADI)
时间窗: 26 Weeks
The shoulder pain and disability index
次要结局
- EuroQuol 5 - Dimensions - 3 Levels (EQ-5D-3L)(26 weeks)
- Hospital Anxiety and Depression Scale (HADS)(26 weeks)
- Global patient self-assessment(26 weeks)
- Short Form 36 version 2 (SF36v2)(26 weeks)
- Internal rotation(26 weeks)
- Active range of external rotation(26 weeks)
研究者
Ian Ryans
General Practitioner
South Eastern Health and Social Care Trust