Validation in French Language of the Questionnaire EARS

NCT ID: NCT03963440

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cohorte 1

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.

Group Type EXPERIMENTAL

Exercise Adherence Rating Scale (EARS)

Intervention Type 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.

Interventions

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Exercise Adherence Rating Scale (EARS)

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.

Intervention Type OTHER

Other Intervention Names

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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)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel COUDEYRE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CHU de Lille

Lille, , France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

CHU de nîmes

Nîmes, , France

Site Status

Hôpital COCHIN

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 2961080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24169445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25511175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11124735 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25108098 (View on PubMed)

Other Identifiers

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2018-A00616-49

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2018 COUDEYRE

Identifier Type: -

Identifier Source: org_study_id

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