Validation in French Language of the Questionnaire EARS

NCT03963440 | Completed

• 2 other identifiers: RNI 2018 COUDEYRE2018-A00616-49
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain; Physical activity; Questionnaire; Adhesion

Outcome Measures

Primary Outcomes (1)

• Psychometric properties of the French questionnaire EARS

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

  0 day, 2 days, 15 days, 3 months

Secondary Outcomes (9)

• The fears and the faiths measured by questionnaire FABQ

  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

• Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ

  at day 0, 15 days, 3 months

Study Arms (1)

Cohorte 1

EXPERIMENTAL

Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care). Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care. Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments.

Other: Exercise Adherence Rating Scale (EARS)

Interventions

Exercise Adherence Rating Scale (EARS) OTHER

Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care). Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care. Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments.

Also known as: Quebec Back Pain Disability Scale, International Physical Activity Scale (IPAQ), Hospital Anxiety and Depression (HAD), Evaluation du fardeau lié à la réalisation des exercices physiques (ETBQ), Back Belief Questionnaire (BBQ), Arthritis Self-Efficacy Scale pour les lombalgies chroniques (ASES), Return To Work Self Efficacy Scale (RTWSE-10 items), Fear Avoidance Belief Questionnaire (FABQ), Impression globale de changement par le patient (PGIC)

Cohorte 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient under guardianship, or protection of justice.
• Patient in the incapacity to answer the questionnaire.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (5)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Lille

Lille, 59000, France

Location

CHU de Montpellier

Montpellier, 34000, France

Location

CHU de nîmes

Nîmes, 30000, France

Location

Hôpital COCHIN

Paris, 75014, France

Location

Related Publications (5)

• 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.

  PMID: 2961080 BACKGROUND

• 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.

  PMID: 24169445 BACKGROUND

• 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.

  PMID: 25511175 BACKGROUND

• 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.

  PMID: 11124735 BACKGROUND

• 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.

  PMID: 25108098 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Tissue Adhesions

Condition Hierarchy (Ancestors)

Behavior; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel COUDEYRE, MD-PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 24, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 15, 2024

Record last verified: 2019-05

Locations

FR (5)