Clinical trial NCT03088969: Validation of the French Version RTWSE (Return To Work Self Efficacy Scale)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Keywords: Chronic Low Back Pain
Function
Self-efficacy
Return to work
Questionnaire
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a chronic back pain

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
timeFrame: at 0 day
measure: Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
timeFrame: at 3 days
measure: Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
timeFrame: at 21 days
measure: Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
timeFrame: at 2 months
Secondary outcomes:
measure: The fears and the faiths measured by questionnaire FABQ
timeFrame: at day 0
measure: The fears and the faiths measured by questionnaire FABQ
timeFrame: at 21 days
measure: The fears and the faiths measured by questionnaire FABQ
timeFrame: at 2 months
measure: Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
timeFrame: at day 0
measure: Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
timeFrame: at day 3
measure: Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
timeFrame: at day 21
measure: Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
timeFrame: at 2 months
measure: Level of physical activity measured by short questionnaire IPAQ
timeFrame: at day 0
measure: Level of physical activity measured by short questionnaire IPAQ
timeFrame: at 2 months
measure: The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
timeFrame: at day 0
measure: The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
timeFrame: at 3 days
measure: The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
timeFrame: at 2 months
measure: The knowledge of emotional state measured by questionnaire HAD
timeFrame: at day 0
measure: The knowledge of emotional state measured by questionnaire HAD
timeFrame: at 21 days
measure: Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
timeFrame: at day 0
measure: Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
timeFrame: at 21 days
measure: Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
timeFrame: at 2 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel COUDEYRE
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: Gourmelen J, Chastang JF, Ozguler A, Lanoe 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. doi: 10.1016/j.annrmp.2007.05.009. Epub 2007 Jun 27. English, French.
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. doi: 10.1136/jech.54.3.215.
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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.
citation: Craig CL, Marshall AL, Sjostrom 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. doi: 10.1249/01.MSS.0000078924.61453.FB.
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. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.