Validation of the Evaluation of the Perception of Physical Activity Questionnaire Adapted to Chronic Low Back Pain (EPAP-LOMB)

Validation du Questionnaire d'Evaluation de la Perception de l'Activité Physique (EPAP) adapté à la Lombalgie Chronique

Physical exercise has a fundamental position in the chronic low back pain treatment. However, the physical activity level is often low in these patients and the adherence to the care program is not enough in the long term. The French Evaluation of the Perception of Physical Activity (EPPA) is a valid and reliable questionnaire, developed by N. Coste et al in 2020, that assesses the perceived barriers to and facilitators of physical activity in patients with knee osteoarthritis. To our knowledge, there is no valid and reliable instrument allowing such an assessment in chronic low back pain.

The main objective of this study is to adapt the EPPA to chronic low back pain and to evaluate its psychometric properties.

This validation would allow its use in current practice to adapt the care strategy, to personalize rehabilitation of each patient with chronic low back pain in order to have a better adherence to rehabilitation programs.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low Back Pain

Detailed Description

The EPPA was adapted to chronic low back pain and named EPPA-LOMB. It comprises 26 items.

Patients with chronic low back pain will be recruited during a medical consultation in the Physical Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand and the Notre-Dame Functional Rehabilitation Center of Chamalières (France); or the first day of a functional spine rehabilitation program (3-week program in a day hospital) in the Physical Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand.

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.

All patients will complete questionnaires at inclusion.

Patients included during a medical consultation will receive an e-mail to complete online the EPPA-LOMB and visual analogic scales on pain and level of physical activity, 7 days after inclusion.

Patients included the first day of a functional spine rehabilitation program will complete questionnaires at the end of the program, 21 days after inclusion. They will be seen 3 months after their discharge during a follow-up medical consultation and will complete another time the questionnaires. Only patients not included in the study E-lombactifs (NCT04264949) will complete the questionnaire at 3 months.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Emmanuel Coudeyre
    • Contact: Emmanuel Coudeyre; Email: ecoudeyre@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic low back pain seen in the Physical Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand and in the Notre-Dame Functional Rehabilitation Center of Chamalières (France).

Description

Inclusion Criteria:

• Adults (18 years old and older)
• Patients with chronic low back pain evolving for at least 3 months, with a diagnosis confirmed by the French Health Authority and the classification from the French and European recommendations, that is lumbar pain, without red flags, with a possible pain radiculopathy
• Acceptance to participate in the study.
• Capable of providing informed consent to participate in this study.

Exclusion Criteria:

• Patients not diagnosed according to the French Health Authority and the classification from the French and European recommendations
• Refusal to participate
• Patients in the incapacity to answer the questionnaires
• Patients with a medical contraindication to physical activity
• Patients under guardianship, or protection of justice.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EPPA-LOMB	Acceptability, internal validity, convergent validity, validity of structure against external criteria of the French questionnaire EPPA-LOMB.	0 day
Change of EPPA-LOMB from baseline at 7 days	Test-retest reliability of the French questionnaire EPPA-LOMB.	0 day, 7 days
Change of EPPA-LOMB from baseline at 21 days	Responsiveness of the French questionnaire EPPA-LOMB.	0 day, 21 days
Change of EPPA-LOMB from baseline at 3 months	Responsiveness of the French questionnaire EPPA-LOMB.	0 day, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogic scale for physical activity	Visual analogic scale for physical activity (VAS physical activity) from 0- no physical activity to 10-very intense physical activity	0 day, 7 days, 21 days, 3 months
Visual analogic scale for pain	Visual analogic scale for pain (VAS pain) from 0-no pain to 10-the worst pain	0 day, 7 days, 21 days, 3 months
OSWESTRY Disability Index (ODI)	The functional disability is measured by the OSWESTRY Disability Index (ODI). Ten items rated from 0 to 5 compose a valid and reliable scale with a total score ranging between 0 and 50.	0 day, 21 days, 3 months
Fear Avoidance Belief Questionnaire (FABQ)	The fears and the faiths are measured by the Fear Avoidance Belief 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 and "FABQ-PA" can range from 0-24 points.	0 day, 21 days, 3 months
Exercise Adherence Rating Scale (EARS)	The Exercise Adherence Rating Scale (EARS) is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.A 6-item adherence scale assess adherence to prescribed home exercise. These six items are scored on a 5-point Likert scale (0 = completely agree, 4 = completely disagree). Items 2, 3 and 5 are negatively worded questions. Therefore, higher sum scores (0-24) indicate greater exercise adherence by reversing scores of Items 1, 4, and 6. Ten supplementary items assess reasons for adherence and non-adherence.	0 day, 21 days, 3 months
the Hospital Anxiety and Depression Scale (HADS)	The knowledge of emotional state is measured by the Hospital Anxiety and Depression Scale (HADS). The 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. The questionnaire, comprising fourteen items. Each item is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.	0 day, 21 days, 3 months
Socio-demographic and medical characteristics.	Gender, age, body mass index, time since first symptoms, family situation, edicational level, type and frequency of regular physical activities, type and frequency of regular leisure activities, type of treatment provided for chronic low back pain, comorbidity, antalgic treatment	0 day

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre de Rééducation Fonctionnelle de Notre-Dame, Chamalières
• Investigators: Principal Investigator: Emmnauel COUDEYRE, ecoudeyre@chu-clermontferrand.fr

Publications and helpful links

General Publications

• Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
• Bailly F, Trouvin AP, Bercier S, Dadoun S, Deneuville JP, Faguer R, Fassier JB, Koleck M, Lassalle L, Le Vraux T, Liesse B, Petitprez K, Ramond-Roquin A, Renard JF, Roren A, et al. Recommandations et arbre décisionnel sur la prise en charge de la lombalgie avec ou sans radiculalgie. Revue du Rhumatisme. 2022 ; 89 : 345-353.

Helpful Links

• French Health Authority recommendations for the diagnosis of chronic low back pain

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Chronic low back pain; Barriers; Patient-reported outcome; Psychometric properties; Facilitators
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: RNI 2023 COUDEYRE; 2023-A00504-41 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No