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Completed

NCT Number: NCT03088969

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaire RTWSE

Other

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.

Primary outcomes

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

    Time frame: at 0 day

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

    Time frame: at 3 days

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

    Time frame: at 21 days

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

    Time frame: at 2 months

Secondary outcomes

  1. The fears and the faiths measured by questionnaire FABQ

    Time frame: at day 0

  2. The fears and the faiths measured by questionnaire FABQ

    Time frame: at 21 days

  3. The fears and the faiths measured by questionnaire FABQ

    Time frame: at 2 months

  4. Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)

    Time frame: at day 0

  5. Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)

    Time frame: at day 3

  6. Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)

    Time frame: at day 21

  7. Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)

    Time frame: at 2 months

  8. Level of physical activity measured by short questionnaire IPAQ

    Time frame: at day 0

  9. Level of physical activity measured by short questionnaire IPAQ

    Time frame: at 2 months

  10. The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain

    Time frame: at day 0

  11. The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain

    Time frame: at 3 days

  12. The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain

    Time frame: at 2 months

  13. The knowledge of emotional state measured by questionnaire HAD

    Time frame: at day 0

  14. The knowledge of emotional state measured by questionnaire HAD

    Time frame: at 21 days

  15. Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC

    Time frame: at day 0

  16. Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC

    Time frame: at 21 days

  17. Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC

    Time frame: at 2 months

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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)

Acronym: RTWSE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 24, 2017
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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