Clinical trial NCT05942196: Validation of the Evaluation of the Perception of Physical Activity Questionnaire Adapted to Chronic Low Back Pain
Official title: Validation Du Questionnaire D'Evaluation De La Perception De L'Activité Physique (EPAP) Adapté À La Lombalgie Chronique
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Physical activity
Patient-reported outcome
Facilitators
Barriers
Psychometric properties
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Centre de Rééducation Fonctionnelle de Notre-Dame, Chamalières
First posted: 2023-07-12
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: EPPA-LOMB
timeFrame: 0 day
measure: Change of EPPA-LOMB from baseline at 7 days
timeFrame: 0 day, 7 days
measure: Change of EPPA-LOMB from baseline at 21 days
timeFrame: 0 day, 21 days
measure: Change of EPPA-LOMB from baseline at 3 months
timeFrame: 0 day, 3 months
Secondary outcomes:
measure: Visual analogic scale for physical activity
timeFrame: 0 day, 7 days, 21 days, 3 months
measure: Visual analogic scale for pain
timeFrame: 0 day, 7 days, 21 days, 3 months
measure: OSWESTRY Disability Index (ODI)
timeFrame: 0 day, 21 days, 3 months
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: 0 day, 21 days, 3 months
measure: Exercise Adherence Rating Scale (EARS)
timeFrame: 0 day, 21 days, 3 months
measure: the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 day, 21 days, 3 months
measure: Socio-demographic and medical characteristics.
timeFrame: 0 day
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: ecoudeyre@chu-clermontferrand.fr
name: Emmnauel COUDEYRE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.