Clinical trial NCT03963440: Validation in French Language of the Questionnaire EARS
Official title: Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Physical activity
Questionnaire
Adhesion
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cross-cultural validation study of a questionnaire, interventional research involving the human person chronic low back pain, prospective, with cross-sectional cohort follow-up, multi-centric
Primary purpose: SCREENING

Brief summary: The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain.

Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. It is therefore of paramount importance that compliance with such treatment be assessed to allow for readjustments, as well as drug treatment. No gold standard6-7 measured patient adherence to exercise programs until the creation of the EARS in 2016 by E.Godfrey and his team (Exercise Adherence Rating Scale, literally "joining physical exercise programs")

EARS is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.

Detailed description: Self-management of the patient to perform these exercises involves good collaboration with the care prescriber, leaving patients to manage and monitor their health. Long-term adherence to care programs, including physical exercise, is paramount for these patients in order to maintain a beneficial long-term effect, which is the case in non-specific chronic low back pain. However, evidence shows that compliance levels following a physical exercise prescription are low, limiting the benefits this could bring.

Currently, EARS is validated for chronic low back pain in its English version. To our knowledge and to the knowledge of the questionnaire's author, E.Godfrey, there are no other studies that have examined the validation of EARS in the French language for chronic low back pain.

Patients will be asked to complete a series of questionnaires after completing the non-opposition form. The management of non-specific chronic low back pain also requires evaluation through questionnaires, in accordance with the usual practices of the services participating in the study. No intervention will be taken.

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 French questionnaire EARS
timeFrame: 0 day, 2 days, 15 days, 3 months
Secondary outcomes:
measure: The fears and the faiths measured by questionnaire FABQ
timeFrame: at day 0, 15 days, 3 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, 15 days, 3 months
measure: The knowledge of emotional state measured by questionnaire HAD
timeFrame: at day 0, 15 days, 3 months
measure: Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC
timeFrame: at day 0, 15 days, 3 months
measure: Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ
timeFrame: at day 0, 15 days, 3 months
measure: The personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"
timeFrame: at day 0, 15 days, 3 months
measure: The evaluation of the self-efficiency perceived of return in the work by means of the questionnaire RTWSE (10 items)
timeFrame: at day 0, 15 days, 3 months
measure: Level of physical activity measured by short questionnaire IPAQ
timeFrame: at day 0, 15 days, 3 months
measure: Patient Global Impression of Change by Scale PGIC
timeFrame: 15 days, 3 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Lille
country: France
facility: CHU de Lille
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de nîmes
city: Paris
country: France
facility: Hôpital COCHIN
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Emmanuel COUDEYRE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. doi: 10.1097/00007632-198709000-00002.
citation: Beinart NA, Goodchild CE, Weinman JA, Ayis S, Godfrey EL. Individual and intervention-related factors associated with adherence to home exercise in chronic low back pain: a systematic review. Spine J. 2013 Dec;13(12):1940-50. doi: 10.1016/j.spinee.2013.08.027. Epub 2013 Oct 26.
citation: Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
citation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
citation: Hall AM, Kamper SJ, Hernon M, Hughes K, Kelly G, Lonsdale C, Hurley DA, Ostelo R. Measurement tools for adherence to non-pharmacologic self-management treatment for chronic musculoskeletal conditions: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):552-62. doi: 10.1016/j.apmr.2014.07.405. Epub 2014 Aug 6.