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临床试验/NCT01648738
NCT01648738
已完成
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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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 88 人2012年7月
适应症Low Back Pain

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Low Back Pain
发起方
Assistance Publique - Hôpitaux de Paris
入组人数
88
试验地点
1
主要终点
Frequency of return to work
状态
已完成
最后更新
8年前

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.

注册库
clinicaltrials.gov
开始日期
2012年7月
结束日期
2016年4月
最后更新
8年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

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

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

  • Pain(Every 2 weeks during 1 year)
  • Function(1 year)
  • Quality of life(1 year)
  • TWIST(1 year)
  • Sick leave(1 year)

研究点 (1)

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