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出境医 / 临床实验 / Validation in French Language of the Questionnaire EARS (EARS)

Validation in French Language of the Questionnaire EARS (EARS)

Study Description
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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
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
Arms and Interventions
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)

Outcome Measures
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.



Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Emmanuel COUDEYRE, MD-PhD University Hospital, Clermont-Ferrand
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
Psychometric properties of the French questionnaire EARS [ Time Frame: 0 day, 2 days, 15 days, 3 months ]
Acceptability: data quality will be considered satisfactory if more than 95% of the scale date are fully computable. Internal Consistency will be determined through Cronbach's α coefficient.Internal validity will be determined by study of correlation between the domains composing the scale (standard, P=0.30-0.70). Reproducibility: Lin concordance correlation coefficient will be used to determine the test-retest reliability of the EARS scale. Convergent and Divergent Validity. The relationships between EARS scale score and other quantitative measures (FABQ, BBQ, ETBQ) will be studied using correlation coefficients (Pearson or Spearman according to statistical distribution).Questionnaire responses will also be confronted with HAD, IPAQ, ASES and RTWSE scales. Sensitivity to change: Calculation of the effect-size will be performed Comparing pre and post-re-education EARS values will be proposed to study sensitivity to change. Correlation between PGIC score and EARS score will be studied
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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.
  • 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.
  • 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
  • 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.
  • 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)
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation in French Language of the Questionnaire EARS
Official Title  ICMJE Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE 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)
Study Arms  ICMJE 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.

Intervention: Other: Exercise Adherence Rating Scale (EARS)
Publications *
  • 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. Review.
  • 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. Review.
  • Bocéréan 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.
  • 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. Review.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963440
Other Study ID Numbers  ICMJE RNI 2018 COUDEYRE
2018-A00616-49 ( Other Identifier: 2018-A00616-49 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel COUDEYRE, MD-PhD University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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