Chronic Low Back PainRTWSENCT03088969
Validation of the French Version RTWSE (Return To Work Self Efficacy Scale)
An observational study of Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- questionnaire RTWSE
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to 30 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a chronic back pain
Who may be able to join
- 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)
Who cannot join
- Patient under guardianship, or protection of justice.
- Patient in the incapacity to answer the questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- questionnaire RTWSE
- Keywords
- Chronic Low Back Pain, Function, Self-efficacy, Return to work, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire RTWSEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patient with a chronic back pain | Not described Receives: Other: questionnaire RTWSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Measured: at 0 day
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Measured: at 3 days
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Measured: at 21 days
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Measured: at 2 months
Secondary outcomes (17)
The fears and the faiths measured by questionnaire FABQ
Measured: at day 0
The fears and the faiths measured by questionnaire FABQ
Measured: at 21 days
The fears and the faiths measured by questionnaire FABQ
Measured: at 2 months
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Measured: at day 0
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Measured: at day 3
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Measured: at day 21
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Measured: at 2 months
Level of physical activity measured by short questionnaire IPAQ
Measured: at day 0
Level of physical activity measured by short questionnaire IPAQ
Measured: at 2 months
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
Measured: at day 0
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
Measured: at 3 days
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
Measured: at 2 months
The knowledge of emotional state measured by questionnaire HAD
Measured: at day 0
The knowledge of emotional state measured by questionnaire HAD
Measured: at 21 days
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
Measured: at day 0
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
Measured: at 21 days
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
Measured: at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startApr 2016
- Primary completionDec 2017
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088969
- Sponsor's protocol ID
- CHU-309
- Acronym
- RTWSE
- Status last verified
- Oct 2019
- First submitted
- 20 Mar 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19818666Gourmelen 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.
PubMed 17631977Ozguler 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.
PubMed 10746116Brouwer 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.
PubMed 20865445Shaw 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.
PubMed 21203742Craig 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.
PubMed 12900694Terwee 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.
PubMed 17161752
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03088969
- Acronym / sponsor ID
- RTWSE / CHU-309
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Function, Self-efficacy, Return to work, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with a chronic back pain | – | Other: questionnaire RTWSE |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a chronic back pain
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Patient under guardianship, or protection of justice.
- Patient in the incapacity to answer the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire RTWSEThe 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. | Other | patient with a chronic back pain |
Primary outcome
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Time frame: at 0 day
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Time frame: at 3 days
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Time frame: at 21 days
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items)
Time frame: at 2 months
17 secondary outcomes
The fears and the faiths measured by questionnaire FABQ
Time frame: at day 0
The fears and the faiths measured by questionnaire FABQ
Time frame: at 21 days
The fears and the faiths measured by questionnaire FABQ
Time frame: at 2 months
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Time frame: at day 0
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Time frame: at day 3
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Time frame: at day 21
Average change from baselin in the pain intensity measured on a Visual Analogical Scale (VAS)
Time frame: at 2 months
Level of physical activity measured by short questionnaire IPAQ
Time frame: at day 0
Level of physical activity measured by short questionnaire IPAQ
Time frame: at 2 months
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
Time frame: at day 0
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
Time frame: at 3 days
The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain
Time frame: at 2 months
The knowledge of emotional state measured by questionnaire HAD
Time frame: at day 0
The knowledge of emotional state measured by questionnaire HAD
Time frame: at 21 days
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
Time frame: at day 0
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
Time frame: at 21 days
Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
Time frame: at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 19818666Rossignol 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.
- Background: PubMed 17631977Gourmelen 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.
- Background: PubMed 10746116Ozguler 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.
- Background: PubMed 20865445Brouwer 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.
- Background: PubMed 21203742Shaw 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.
- Background: PubMed 12900694Craig 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.
- Background: PubMed 17161752Terwee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COUDEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric properties of the questionnaires RTWSE (Return To Work Self Efficacy Scale, 10 et 19 items) (time frame: at 0 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088969, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.