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Completed

NCT Number: NCT04931758

Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain

In patients with chronic low back pain, the Fremantle Back Awareness Questionnaire (FreBAQ) measures the duration and intensity of pain and functional limitations. The FreBAQ is a simple tool created to assess disturbances in the body representation of the back, and the only one existing in chronic low back pain. It is a 9-item self-questionnaire in which each item is measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)". It assesses neglect, perceived body image of the back, accuracy in proprioceptive perception of back movements.

The psychometric properties of the FreBAQ in English, Japanese, Dutch, Turkish and German are validated and acceptable; however, they have never been studied in French and no validated version of this questionnaire in French exists.

The study investigators hypothesize that the French version of the FreBAQ has good psychometric qualities, allowing it to be used in the French chronic low back pain population.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject with no history of chronic low back pain and with a lumbar VAS <2 for more than 3 months.
  • Patient with chronic low back pain: pain localized between the edge of the last lower ribs and the intergluteal groove (17) for more than 3 months.
  • Patient with a lumbar VAS > 2 for more than 3 months.
  • Patient whose low back pain is of common origin (no underlying organic etiology).
  • In case of lumbar-radicular pain, patient with a VAS (lumbar) > VAS (leg)
  • Patient who speaks and understands French
  • Patient with no history of arthrodesis or lumbar disc prosthesis
  • Subject affiliated or beneficiary of a health insurance plan.
  • The patient must have given their free and informed consent and signed the consent form

Exclusion criteria

  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient pregnant, parturient or breastfeeding

Treatment and study plan

Pain questionnaire

Other

Subjects will take the FreBAQ questionnaire at Day 0 and a subgroup of 35 controls and 15 patients will take the same questionnaire at Day 7

Primary outcomes

  1. Pre-test of French version of FreBAQ on 20 representative patients

    Time frame: Baseline

    9-item self-administered questionnaire newly translated into French using a standard translation-retro-translation system, each item measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)

Secondary outcomes

  1. FreBAQ score

    Time frame: Day 0

    a 9-item self-administered questionnaire, each item measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)

  2. FreBAQ score in a subgroup of 50 subjects (35 patients and 15 controls)

    Time frame: Day 7

    a 9-item self-administered questionnaire, each item measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)

  3. Evaluation of the internal consistency of the French version of the FreBAQ

    Time frame: Day 0

    Analyzed by calculating Cronbach's alpha.

  4. Evaluation of the unidimensionality of the French version of the FreBAQ

    Time frame: Day 0

    Analyzed using principal component analysis methods

  5. Assessment of the reliability (test-retest) of the questionnaire in French

    Time frame: Day 7

    Measurement of the reliability of the questionnaire in French between the initial test and a test at Day 7: calculation of Bland & Altman's limits of agreement,

  6. Assessment of the reproducibility (test-retest) of the questionnaire in French

    Time frame: Day 7

    Measurement of the reproducibility of the questionnaire in French between the initial test and a test at Day 7: calculation of the intra-class correlation coefficient

  7. Assessment of the discriminant validity of the questionnaire in French

    Time frame: Day 0

    Comparison of scores between control subjects and chronic low back pain patients by calculating the area under the ROC curve

  8. Assessment of the concurrent validity

    Time frame: Day 0

    Correlation of the French questionnaire score with the duration of low back pain

  9. Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest

    Time frame: Day 0

    FreBAQ score compared with VAS result

  10. Correlation of the French questionnaire score with lumbar VAS in movement

    Time frame: Day 0

    FreBAQ score compared with VAS result

  11. Correlation of the French questionnaire score with disability

    Time frame: Day 0

    FreBAQ score compared with Oswestry Disability Index - a 10-section questionnaire with a results calculated as a percentage

  12. Correlation of the French questionnaire score with false beliefs

    Time frame: Day 0

    FreBAQ score compared with back beliefs questionnaire - a 14-tem questionnaire on a 0-5 scale

  13. Correlation of the French questionnaire score with fear avoidance beliefs

    Time frame: Day 0

    FreBAQ score compared with Fear Avoidance Belief Questionnaire - 16-item questionnaire scored between 0-6. Scale 1 = beliefs about work with a score ranging from 0 -42; Scale 2 = beliefs about physical activity with a score ranging from 0-24

  14. Correlation of the French questionnaire score with kinesiophobia

    Time frame: Day 0

    FreBAQ score compared with Tampa scale of Kinesiophobia - total score 68, with a cut-off of 40 for significant kinesiophobia

  15. Correlation of the French questionnaire score with catastrophism

    Time frame: Day 0

    FreBAQ score compared with Pain Catastrophizing Scale - a 13-item questionnaire on a 0-4 Likert scale

  16. Correlation of the French questionnaire score with anxiety and depression

    Time frame: Day 0

    FreBAQ score compared with Hospital Anxiety and Depression Scale - a 14-item questionnaire on a 0-9 Likert scale

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: FreBAQ

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Dec 10, 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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