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

Chronic Low Back Pain Clinical Trial

— RTWSE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088969
• Other study ID #: CHU-309
• Status: Completed
• Start date: April 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 30, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• questionnaire RTWSE
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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (7)

Brouwer S, Franche RL, Hogg-Johnson S, Lee H, Krause N, Shaw WS. Return-to-work self-efficacy: development and validation of a scale in claimants with musculoskeletal disorders. J Occup Rehabil. 2011 Jun;21(2):244-58. doi: 10.1007/s10926-010-9262-4. — View Citation

Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. — View Citation

Gourmelen J, Chastang JF, Ozguler A, Lanoë JL, Ravaud JF, Leclerc A. Frequency of low back pain among men and women aged 30 to 64 years in France. Results of two national surveys. Ann Readapt Med Phys. 2007 Nov;50(8):640-4, 633-9. Epub 2007 Jun 27. English, French. — View Citation

Ozguler A, Leclerc A, Landre MF, Pietri-Taleb F, Niedhammer I. Individual and occupational determinants of low back pain according to various definitions of low back pain. J Epidemiol Community Health. 2000 Mar;54(3):215-20. — View Citation

Rossignol M, Rozenberg S, Leclerc A. Epidemiology of low back pain: what's new? Joint Bone Spine. 2009 Dec;76(6):608-13. doi: 10.1016/j.jbspin.2009.07.003. — View Citation

Shaw WS, Reme SE, Linton SJ, Huang YH, Pransky G. 3rd place, PREMUS best paper competition: development of the return-to-work self-efficacy (RTWSE-19) questionnaire--psychometric properties and predictive validity. Scand J Work Environ Health. 2011 Mar;37(2):109-19. doi: 10.5271/sjweh.3139. Epub 2011 Jan 4. — View Citation

Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. Epub 2006 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)		at 0 day
Primary	Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)		at 3 days
Primary	Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)		at 21 days
Primary	Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)		at 2 months
Secondary	The fears and the faiths measured by questionnaire FABQ		at day 0
Secondary	The fears and the faiths measured by questionnaire FABQ		at 21 days
Secondary	The fears and the faiths measured by questionnaire FABQ		at 2 months
Secondary	Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)		at day 0
Secondary	Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)		at day 3
Secondary	Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)		at day 21
Secondary	Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)		at 2 months
Secondary	Level of physical activity measured by short questionnaire IPAQ		at day 0
Secondary	Level of physical activity measured by short questionnaire IPAQ		at 2 months
Secondary	The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain		at day 0
Secondary	The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain		at 3 days
Secondary	The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain		at 2 months
Secondary	The knowledge of emotional state measured by questionnaire HAD		at day 0
Secondary	The knowledge of emotional state measured by questionnaire HAD		at 21 days
Secondary	Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC		at day 0
Secondary	Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC		at 21 days
Secondary	Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC		at 2 months