Clinical trial NCT04931758: Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain
Official title: Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic low back pain defined as pain localized between the edge of the last lower ribs and the intergluteal groove (17) for more than 3 months followed in the Physical Medicine and Rehabilitation Department of the CHU of Nîmes and persons recruited among the members of the service and their entourage, as well as all patients coming for consultation in the service with no history of chronic low back pain and lumbar VAS \< 2 for more than 3 months.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pre-test of French version of FreBAQ on 20 representative patients
timeFrame: Baseline
Secondary outcomes:
measure: FreBAQ score
timeFrame: Day 0
measure: FreBAQ score in a subgroup of 50 subjects (35 patients and 15 controls)
timeFrame: Day 7
measure: Evaluation of the internal consistency of the French version of the FreBAQ
timeFrame: Day 0
measure: Evaluation of the unidimensionality of the French version of the FreBAQ
timeFrame: Day 0
measure: Assessment of the reliability (test-retest) of the questionnaire in French
timeFrame: Day 7
measure: Assessment of the reproducibility (test-retest) of the questionnaire in French
timeFrame: Day 7
measure: Assessment of the discriminant validity of the questionnaire in French
timeFrame: Day 0
measure: Assessment of the concurrent validity
timeFrame: Day 0
measure: Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest
timeFrame: Day 0
measure: Correlation of the French questionnaire score with lumbar VAS in movement
timeFrame: Day 0
measure: Correlation of the French questionnaire score with disability
timeFrame: Day 0
measure: Correlation of the French questionnaire score with false beliefs
timeFrame: Day 0
measure: Correlation of the French questionnaire score with fear avoidance beliefs
timeFrame: Day 0
measure: Correlation of the French questionnaire score with kinesiophobia
timeFrame: Day 0
measure: Correlation of the French questionnaire score with catastrophism
timeFrame: Day 0
measure: Correlation of the French questionnaire score with anxiety and depression
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU Nîmes
name: Alexis Homs
role: PRINCIPAL_INVESTIGATOR
References: