Validation of the French Version RTWSE (Return To Work Self Efficacy Scale)

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: questionnaire RTWSE

• Registration Number: NCT03088969
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-24
• Primary Completion: 2017-12
• Study Completion: 2018-07-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient with a chronic back pain	questionnaire RTWSE	-

Primary Outcome Measures

Name	Time	Method
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)	at 2 months

Secondary Outcome Measures

Name	Time	Method
The fears and the faiths measured by questionnaire FABQ	at 2 months
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)	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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France