Physiotherapy in Adhesive Capsulitis Pathology: Effect of an Education Based Approach on Arthroscopic Evaluation Results, Joint Range of Motion, Psychosocial Factors, Shoulder Pain and Arm Function
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- parameters on arthrographic investigation by means of MRI
研究概览
简要总结
This study aims, by means of a randomized control trial, to investigate which treatment method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises) gives better results on clinically relevant outcomes (range of glenohumeral motion, psychological factors, pain, shoulder function, quality of life) and on parameters derived from arthroscopic glenohumeral investigation by means of MRI.
Furthermore, associations between (1) the results on the MRI investigation, (2) the range of glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be assessed at different time-points (before and at 6-12-18 and 52 weeks after the first injection).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 % loss of passive GH external rotation motion, together with motion losses greater than 25% in at least two other GH movements, as compared to the unaffected side
- •the pain accompanying the motion losses has to be present for at least one month. During that month, the pain and mobility deficits have to be stable or get worse
排除标准
- •bilateral frozen shoulder
- •systemic and/or neurologic disease or a self-reported pathologic condition of the cervical/thoracic region, elbow or wrist/hand
研究组 & 干预措施
manual therapy and home-exercises
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
干预措施: Physical therapy focus on manual therapy and home-exercises (Other)
education and supported home exercises
corticosteroid injection + physiotherapy with focus on education and supported home exercises
干预措施: Physical therapy focus on education and supported home exercises (Other)
结局指标
主要结局
parameters on arthrographic investigation by means of MRI
时间窗: week 18
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Scapulothoracic, glenohumeral and elbow joint range of motion
时间窗: week 52
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Disability of the shoulder, elbow and hand questionnaire
时间窗: week 52
assessment of upper limb function
Brief pain inventory
时间窗: week 52
assessment of current, worst and night pain on a 11 point likert scale
次要结局
- Tampa scale of kinesiophobia(week 52)
- Hospital anxiety and depression scale(week 52)
- EQ-5D-5L questionnaire(week 52)
- Self-efficacy questionnaire(week 52)
研究者
Annick Timmermans
prof. dr.
Hasselt University