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Completed

NCT Number: NCT05942196

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

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.

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Key information

Conditions

Chronic Low Back Pain Behavior Motor Activity

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. EPPA-LOMB

    Time frame: 0 day

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

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

    Time frame: 0 day, 7 days

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

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

    Time frame: 0 day, 21 days

    Responsiveness of the French questionnaire EPPA-LOMB.

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

    Time frame: 0 day, 3 months

    Responsiveness of the French questionnaire EPPA-LOMB.

Secondary outcomes

  1. Visual analogic scale for physical activity

    Time frame: 0 day, 7 days, 21 days, 3 months

    Visual analogic scale for physical activity (VAS physical activity) from 0- no physical activity to 10-very intense physical activity

  2. Visual analogic scale for pain

    Time frame: 0 day, 7 days, 21 days, 3 months

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

  3. OSWESTRY Disability Index (ODI)

    Time frame: 0 day, 21 days, 3 months

    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.

  4. Fear Avoidance Belief Questionnaire (FABQ)

    Time frame: 0 day, 21 days, 3 months

    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.

  5. Exercise Adherence Rating Scale (EARS)

    Time frame: 0 day, 21 days, 3 months

    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.

  6. the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 0 day, 21 days, 3 months

    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.

  7. Socio-demographic and medical characteristics.

    Time frame: 0 day

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Centre de Rééducation Fonctionnelle de Notre-Dame, Chamalières

Registry information

Official study title

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

Acronym: EPAP-LOMB

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2023
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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