Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
研究概览
简要总结
A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.
详细描述
Pre-inclusion: information, collection of consent, collection of antecedents and biometric data, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ-C30 and H&N35 questionnaires.
Surgical intervention (J0) and randomization into 2 groups:
Group 1 - systematic early rehabilitation Group 2 - without systematic rehabilitation
M3, M6, M12: collection of complications, adjuvant treatments, number of physiotherapy sessions performed, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ- C30 and H&N35 questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Proficiency in the oral and written French language
- •unilateral or bilateral cervical lymph node dissection preserving the accessory spinal nerve
- •Karnofsky index ≥ 80%
- •Age ≥ 18 years
排除标准
- •cognitive disorders
- •predictable difficulties in compliance with treatment and/or follow-up
- •pre-existing pathology involving shoulder and its mobility, independent of head and neck cancer
- •comorbidity preventing rehabilitation of the shoulder
- •time to start rehabilitation after 6 weeks postoperatively
- •pregnant women
- •majors under guardianship
- •refusal to participate in the study
结局指标
主要结局
Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
时间窗: 6 months postoperatively (M6)
The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.
次要结局
- visual analog score for pain (M3, M6 and M12)(3, 6 and 12 months postoperatively (M3, M6 and M12))
- evaluate the compliance of patients to rehabilitation(12 months postoperatively (M12))
- Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)(3 and 12 months postoperatively (M3 and M12))
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck cancer module (H&N35)(3, 6 and 12 months postoperatively (M3, M6 and M12))
- goniometric measurement of flexion and abduction of the shoulder(3, 6 and 12 months postoperatively (M3, M6 and M12))
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(3, 6 and 12 months postoperatively (M3, M6 and M12))