Validation in French Language of the Questionnaire EARS

Chronic Low Back Pain Clinical Trial

— EARS  

Official title:

Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963440
• Other study ID #: RNI 2018 COUDEYRE
• Secondary ID: 2018-A00616-49
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU de Lille	Lille
France	CHU de Montpellier	Montpellier
France	CHU de nîmes	Nîmes
France	Hôpital COCHIN	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The fears and the faiths measured by questionnaire FABQ	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.	at day 0, 15 days, 3 months
Secondary	The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain	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.	at day 0, 15 days, 3 months
Secondary	The knowledge of emotional state measured by questionnaire HAD	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	at day 0, 15 days, 3 months
Secondary	Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC	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.	at day 0, 15 days, 3 months
Secondary	Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ	(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)	at day 0, 15 days, 3 months
Secondary	The personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"	The ASES includes 20 questions that represent three subscales: pain, function, and other symptoms. Score ranging : from 1 to 10 (higher = greater self-efficacy).	at day 0, 15 days, 3 months
Secondary	The evaluation of the self-efficiency perceived of return in the work by means of the questionnaire RTWSE (10 items)	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.	at day 0, 15 days, 3 months
Secondary	Level of physical activity measured by short questionnaire IPAQ	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.	at day 0, 15 days, 3 months
Secondary	Patient Global Impression of Change by Scale PGIC	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.	15 days, 3 months