Effectiveness of a Short, Intensive and Standardised Spa Therapy for Subacute and Chronic Low Back Pain on Return to Work for Patients in Sick Leave From 4 to 24 Weeks Duration : a Randomized Controlled Trial Using a Modified Zelen Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Frequency of return to work
研究概览
简要总结
The purpose of this study is to determine whether an intensive 5 days long multidisciplinary program (including spa therapy, exercises and patients'education) is more effective regarding return to work than usual care in subacute and chronic low back pain for people in sick leave from 4 to 24 weeks duration, and for which an extension of sick leave is considered
详细描述
Sick leave due to low back pain (LBP) is costly and compromises workforce productivity. Sick leave itself, fears and believes regarding return to work, and a low self-esteem have been identified as independent predictors of extended sick leave. Previous data suggested that multidisciplinary rehabilitation programs, including physical activities and psychobehavioral management, should decrease sick leave duration in chronic LBP. However these programs are heavy (at least 4 weeks long), and are often proposed to patients at the end of the management (over 6 months after the beginning of symptoms). Another approach could be to propose a shorter multidisciplinary program (for example 5 days long), earlier in the history of LBP to break the vicious circle as soon as possible. The target population could be people suffering from subacute LBP with sick leave duration between 4 and 24 weeks.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged from 18 to 60 years (included)
- •Low back pain (or back and radicular pain with back pain the most painful)
- •Sick leave between 4 and 24 weeks duration, without expected return to work
- •A prior medical evaluation is made and the results will be communicated to the patient
- •Patient giving his informed consent to participate in the study
- •Patient affiliated to or beneficiary of social insurance
排除标准
- •Cognition or behavioral disorders making it impossible to assess
- •Inability to speak and write French
- •Contra-indication to perform a short spa therapy
研究组 & 干预措施
Spa therapy, exercise and educational therapy
Spa therapy, exercise and educational therapy
干预措施: Spa therapy, exercise and educational therapy (Other)
Usual care and counselling (Back book)
Usual care and counselling (Back book)
干预措施: Usual care (Other)
结局指标
主要结局
Frequency of return to work
时间窗: 1 year
Frequency of return to work 1 year after the inclusion date
次要结局
- Function(1 year)
- Pain(Every 2 weeks during 1 year)
- Quality of life(1 year)
- TWIST(1 year)
- Sick leave(1 year)