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AzTrials

Chronic Low Back PainEPAP-LOMBNCT05942196

Validation of the Evaluation of the Perception of Physical Activity Questionnaire Adapted to Chronic Low Back Pain

An observational study of Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Chronic Low Back Pain
How many people
99 participants
Where
1 siteFrance
Study dates
12 Jun 2023to 28 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
Chronic low back pain, Physical activity, Patient-reported outcome, Facilitators, Barriers, Psychometric properties
Medical subject headings
Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EPPA-LOMB

    Acceptability, internal validity, convergent validity, validity of structure against external criteria of the French questionnaire EPPA-LOMB.

    Measured: 0 day

  2. Change of EPPA-LOMB from baseline at 7 days

    Test-retest reliability of the French questionnaire EPPA-LOMB.

    Measured: 0 day, 7 days

  3. Change of EPPA-LOMB from baseline at 21 days

    Responsiveness of the French questionnaire EPPA-LOMB.

    Measured: 0 day, 21 days

  4. Change of EPPA-LOMB from baseline at 3 months

    Responsiveness of the French questionnaire EPPA-LOMB.

    Measured: 0 day, 3 months

Secondary outcomes (7)

  1. 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

    Measured: 0 day, 7 days, 21 days, 3 months

  2. Visual analogic scale for pain

    Visual analogic scale for pain (VAS pain) from 0-no pain to 10-the worst pain

    Measured: 0 day, 7 days, 21 days, 3 months

  3. 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.

    Measured: 0 day, 21 days, 3 months

  4. 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.

    Measured: 0 day, 21 days, 3 months

  5. 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.

    Measured: 0 day, 21 days, 3 months

  6. 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.

    Measured: 0 day, 21 days, 3 months

  7. 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

    Measured: 0 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start12 Jun 2023
  3. Primary completion9 Jan 2025
  4. Study completion28 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05942196
Sponsor's protocol ID
RNI 2023 COUDEYRE
Other IDs
2023-A00504-41
Acronym
EPAP-LOMB
Status last verified
Jul 2024
First submitted
14 Jun 2023
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 29971708

  • 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.

  • Monborne I, Ducret J, Visa MP, Coudeyre E, Lanhers C, Guiguet-Auclair C. French physical activity perception questionnaire for chronic low back pain: development and preliminary validation. Ann Phys Rehabil Med. 2026 Jun;69(5):102113. doi: 10.1016/j.rehab.2026.102113. Epub 2026 Apr 14.

    PubMed 41985266

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Low Back Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EPPA-LOMB (time frame: 0 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05942196, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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