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Validation in French Language of the Questionnaire EARS (EARS)

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ClinicalTrials.gov Identifier: NCT03963440
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: Exercise Adherence Rating Scale (EARS) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: 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.

Other: 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.

Other Names:
  • 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)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The fears and the faiths measured by questionnaire FABQ [ Time Frame: at day 0, 15 days, 3 months ]

    The FABQ can help predict those that have a high pain avoidance behavior. Clinically, these people may need to be supervised more than those that confront their pain.

    The FABQ contains 2 scales: a work scale (FABQ-W) composed of 7 items and a physical activity scale (FABQ-PA) composed of 4 items. The two scales are scored separately. Higher FABQ scores indicate elevated fear-avoidance beliefs.

    "FABQ-W" has a point score that ranges from 0-42 points. It can be calculated as follows: (Total points for items 6, 7, 9, 10 11, 12 and 15) = Work scale score.

    "FABQ-PA" can range from 0-24 points. Scores are calculated as follows: (Total points for items 2, 3, 4 and 5) = Physical activity scale score.


  2. The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain [ Time Frame: at day 0, 15 days, 3 months ]
    The questionnaire consists of 14 items and each item is scored on a 5‐point Likert agreement scale (ranging from strongly agree to strongly disagree). Only nine items are used in the scoring of the questionnaire with the remaining items considered 'distracters' from which no scores are derived. Possible scores range between 9 and 45, with lower scores indicating more maladaptive or pessimistic beliefs about back pain.

  3. The knowledge of emotional state measured by questionnaire HAD [ Time Frame: at day 0, 15 days, 3 months ]

    The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. HADS gives clinically meaningful results as a psychological screening tool and can assess the symptom severity and caseness of anxiety disorders and depression in patients with illness and the general population.

    One questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

    Scoring :

    0-7- normal, 8-10-borderling abnormal, 11-21-abnormal


  4. Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC [ Time Frame: at day 0, 15 days, 3 months ]
    This questionnaire is about the way your back pain is affecting your daily life. People with back problems may find it difficult to perform some of their daily activities. For each activity there is a scale of 0 to 5 :0 - " not difficult at all " , 1 - " minimally difficult " , 2 - " somewhat difficult " , 3 - " fairly difficult " , 4 - " very difficult " and 5 - " unable to do ". Minimum detectable change (90% confidence) 15 points.

  5. Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ [ Time Frame: at day 0, 15 days, 3 months ]
    (Exercise Therapy Burden Questionnaire), consisting of 10 items. For each activity there is a scale of 0 to 10 : 0 - not agree at all, 10 - completely agree. Some items of the ETBQ belong to side effects and others to the workload of health care. (lower score=better)

  6. The personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale" [ Time Frame: at day 0, 15 days, 3 months ]
    The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).

  7. The evaluation of the self-efficiency perceived of return in the work by means of the questionnaire RTWSE (10 items) [ Time Frame: at day 0, 15 days, 3 months ]
    10-item RTWSE scale with the goal of assessing self-efficacy of workers to return to work within two conceptual domains: controlling pain at work and obtaining help. For each question there is a scale of to 5: 1 - not sure at all, 5 - really sure. Higher score = better self-efficiency.

  8. Level of physical activity measured by short questionnaire IPAQ [ Time Frame: at day 0, 15 days, 3 months ]

    Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level Scoring a MODERATE level of physical activity on the IPAQ means some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days.

    Scoring a LOW level of physical activity on the IPAQ means any of the criteria for either MODERATE of HIGH levels of physical activity.


  9. Patient Global Impression of Change by Scale PGIC [ Time Frame: 15 days, 3 months ]

    This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. It consists of one item.

    Patient choose: 1 -No change (or condition has gotten worse), 2 - Almost the same, hardly any change at all, 3 - A little better, but no noticeable change, 4 - Somewhat better, but the change has not made any real difference, 5 - Moderately better, and a slight but noticeable change, 6 - Better and a definite improvement that has made a real and worthwhile difference, 7 - A great deal better and a considerable improvement that has made all the difference.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963440


Contacts
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Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre       promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Emmanuel COUDEYRE         
CHU de Lille Not yet recruiting
Lille, France, 59000
Principal Investigator: DEMAILLE         
CHU de Montpellier Not yet recruiting
Montpellier, France, 34000
Principal Investigator: TAVARES         
CHU de nîmes Not yet recruiting
Nîmes, France, 30000
Principal Investigator: DUPEYRON         
Hôpital COCHIN Recruiting
Paris, France, 75014
Principal Investigator: NGUYEN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Emmanuel COUDEYRE, MD-PhD University Hospital, Clermont-Ferrand

Publications:
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03963440     History of Changes
Other Study ID Numbers: RNI 2018 COUDEYRE
2018-A00616-49 ( Other Identifier: 2018-A00616-49 )
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Chronic low back pain
Physical activity
Questionnaire
Adhesion

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms