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Clinical Trials/NCT03963440
NCT03963440
Completed
N/A

Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain

University Hospital, Clermont-Ferrand5 sites in 1 country120 target enrollmentFebruary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
120
Locations
5
Primary Endpoint
Psychometric properties of the French questionnaire EARS
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 31, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Psychometric properties of the French questionnaire EARS

Time Frame: 0 day, 2 days, 15 days, 3 months

(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)

Secondary Outcomes

  • The fears and the faiths measured by questionnaire FABQ(at day 0, 15 days, 3 months)
  • Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ(at day 0, 15 days, 3 months)
  • The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain(at day 0, 15 days, 3 months)
  • The knowledge of emotional state measured by questionnaire HAD(at day 0, 15 days, 3 months)
  • Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC(at day 0, 15 days, 3 months)
  • Patient Global Impression of Change by Scale PGIC(15 days, 3 months)
  • The personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"(at day 0, 15 days, 3 months)
  • The evaluation of the self-efficiency perceived of return in the work by means of the questionnaire RTWSE (10 items)(at day 0, 15 days, 3 months)
  • Level of physical activity measured by short questionnaire IPAQ(at day 0, 15 days, 3 months)

Study Sites (5)

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