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 |
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Chronic Low Back Pain | Other: Exercise Adherence Rating Scale (EARS) | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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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:
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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 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
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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lise Laclautre | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
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 |
Principal Investigator: | Emmanuel COUDEYRE, MD-PhD | University Hospital, Clermont-Ferrand |
Tracking Information | |||||
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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 |
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)
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 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 |
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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:
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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)
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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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 |
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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 |