Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-06 @ 9:32 AM
Study NCT ID:
NCT03088969
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the French Version RTWSE (Return To Work Self Efficacy Scale)
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RTWSE
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: