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临床试验/NCT03088969
NCT03088969已完成不适用

Validation of the French Version of the Questionnaires of Self-efficacy Received From the People With a Chronic Low Back Pain After Return to the Work (10 and 19 Items)

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)

研究概览

简要总结

The back pain connected to the work stay a major problem in industrialized countries, in particular because of the repercussions of this affection on the work (sick leave, absenteeism, handicap and inaptitude). It is difficult to consider among all the patients with a Chronic Low Back Pain in the work: how much they are going to stop. However, Investigator can consider that approximately 20 % of the patients have a sick leave. Several studies showed well that more the sick leave work stoppage goes on more the risk of not resumption of work increases. Several risk factors were associated to the evolutionary forecast of the pathology and thus to the extension extra time of the sick leave: individual, environmental, psychosocial and organizational.

The evaluation of the self-efficiency perceived of return in the work of the patients by a validated auto-questionnaire is thus an additional objective parameter determining the risk factors of unfavorable evolution of the patients with Low Back Pain. This parameter also allows highlight other levers of actions in the therapeutic education.

详细描述

First stage: the translation of the RTWSE in French followed the recommendations of the literature, which recommend a double translation, then a double back - translation with synthesis of the data in every stage. A final commission deliberate then a final translation, culturally adapted.

The second stage: the RTWSE is given to the patients with a Chronic Back Pain in the program of functional restoration of the rachis. Questionnaire FABQ, BARBECUE and Quebec are also given to the patient to obtain the status "faith" and the "functional" status. The questionnaire JDI as well as the analog visual scale is given to estimate the global professional satisfaction. The pain is estimated by a digital scale. The score IPAQ allows to estimate the level of physical activity of the patients. The HAD allows to estimate the level of anxiety and depression of the patients.

The additional questionnaires used for several reasons: in routine for the evaluation of the patients with a Chronic Back Pain; to characterize the patients and within the framework of the study for the validity of convergence and difference of questionnaires RTWSE 10 and 19 items.

The third stage: the questionnaire RTWSE is given again to the patient at 72 hours interval while the state of the patient is considered as stable.

The fourth stage: the questionnaires are given at J21 and in 2 months apart for the study of the sensibility in the change with the FABQ, BARBECUE, Quebec and the IPAQ.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes
  • Adult (>18 years old)
  • Chronic Low Back Pain evolving for at least 3 months
  • Acceptance to participate in the study
  • Patients affiliated to a social security scheme (beneficiary entitled)

排除标准

  • Patient under guardianship, or protection of justice.
  • Patient in the incapacity to answer the questionnaire.

结局指标

主要结局

Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)

时间窗: at 2 months

次要结局

  • Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)(at 2 months)
  • The fears and the faiths measured by questionnaire FABQ(at 2 months)
  • Level of physical activity measured by short questionnaire IPAQ(at 2 months)
  • The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain(at 2 months)
  • The knowledge of emotional state measured by questionnaire HAD(at 21 days)
  • Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC(at 2 months)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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