Clinical and MRI Predictive Factors of the Response to Arthrographic Distension and Intensive Physiotherapy in Severe Capsulitis: Improvement of Pain and Function at 1 Month
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Physical Impairment: numeric verbal scale of pain
研究概览
简要总结
The purpose of this study is to identify clinical and MRI factors associated to a better response to arthrographic distension in patients with severe capsulitis.
详细描述
Patients presenting to the physical medicine and rehabilitation department [tertiary care] of Cochin Hospital for severe adhesive capsulitis for whom first-line medical treatment is not effective. The first-line treatment including analgesic, NSAIDs and / or intra-articular infiltration of a corticosteroid derivative and multi-weekly physiotherapy
These patients are integrated into a usual protocol (routine care) consisting of performing an MRI with intravenous injection of gadolinium to confirm the diagnostic and eliminated others causes of shoulder stiffness. IV gadolinium-enhanced MRI can increase the performance of the signal analysis changes of the Synovium and capsule in the Axillary Recess and Rotator interval as compared with unenhanced measures The treatment consists in one to three arthrographic distensions by physiological serum, xylocaine 1% and injection of an ampoule of corticosteroids (DIPROSTENE) associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor). The primary objective of arthrographic distension is the expansion and rupture of the glenohumeral capsule in the subscapularis recess. It consists after local anesthesia, in an injection under pressure of air or liquid - opacifier or physiological serum - in the glenohumeral joint associated with an infiltration of cortisone derivatives at the end of the operation. Physical treatment aimed at rapid amplitude gain is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthro-distension may be repeated once or twice during the mobilization period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age greater than or equal to 18 years,
- •Symptomatic shoulder (pain or stiffness) for at least 3 months.
- •Patient with failure of treatment including at least NSAIDs, analgesics, +/- intra-articular corticosteroid infiltration and physiotherapy.
- •Painful shoulder at inclusion (EN > 5)
- •Limitation of passive amplitudes of the glenohumeral joint, of at least 25% of 2 of the 3 mobility sectors (lateral arm elevation, anterior elevation and lateral rotation in the RE1 position), compared to the opposite side
- •Absence of glenohumeral arthropathy and abarticular calcification on the standard x-ray of both shoulders.
- •Affiliation to a social security
- •Information and collection of patient consent
- •Exclusion Criteria
- •Obtain patient consent impossible
- •Cognitive disorders considered moderate to severe by the investigator
- •Unbalanced diabetes mellitus (glycated hemoglobin> 10%)
- •Anticoagulant treatment that cannot be interrupted
- •Hemostatic disorders (known history, platelet count <120,000, prothrombin level <75%)
- •Allergy to xylocaine, Gadolinium, Diprostene
- •Biological inflammatory syndrome
- •Pregnant woman (beta human chorionic gonadotropin dosage) or breastfeeding
- •Language barrier to the integration of a rehabilitation program or the performance of a reliable assessment.
- •People under protective measures
- •Refusal to participate
排除标准
- 未提供
结局指标
主要结局
Physical Impairment: numeric verbal scale of pain
时间窗: 1 month
self-evaluated numeric verbal scale of pain, ranging from 0 to 10 (lesser is better)
次要结局
- Shoulder Pain and Disability Index (SPADI)(1 month)
- Physical Impairment : mobility of shoulder joints(1 month)
- Fear-Avoidance Beliefs Questionnaire (FABQ)(1 month)
- Psychological Impairment : Hospital Anxiety and Depression Scale (HADS)(1 month)
- Physical Impairment: numeric verbal scale of night pain(1 month)
- Physical Impairment: numeric verbal scale of maximum pain(1 month)
- Disabilities of the Arm, Shoulder and Hand (DASH)(1 months)
- Disability : numeric verbal scale of disability(1 month)