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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Pain Questionnaire

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

• Study Contact: Name: Alexis Homs; Phone Number: 04.66.68.42.36; Email: alexis.homs@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • CHU de NIMES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with low back pain	Other: Pain Questionnaire; 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
Controls	Other: Pain Questionnaire; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-test of French version of FreBAQ on 20 representative patients	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)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FreBAQ score	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)	Day 0
FreBAQ score in a subgroup of 50 subjects (35 patients and 15 controls)	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)	Day 7
Evaluation of the internal consistency of the French version of the FreBAQ	Analyzed by calculating Cronbach's alpha.	Day 0
Evaluation of the unidimensionality of the French version of the FreBAQ	Analyzed using principal component analysis methods	Day 0
Assessment of the reliability (test-retest) of the questionnaire in French	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,	Day 7
Assessment of the reproducibility (test-retest) of the questionnaire in French	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	Day 7
Assessment of the discriminant validity of the questionnaire in French	Comparison of scores between control subjects and chronic low back pain patients by calculating the area under the ROC curve	Day 0
Assessment of the concurrent validity	Correlation of the French questionnaire score with the duration of low back pain	Day 0
Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest	FreBAQ score compared with VAS result	Day 0
Correlation of the French questionnaire score with lumbar VAS in movement	FreBAQ score compared with VAS result	Day 0
Correlation of the French questionnaire score with disability	FreBAQ score compared with Oswestry Disability Index - a 10-section questionnaire with a results calculated as a percentage	Day 0
Correlation of the French questionnaire score with false beliefs	FreBAQ score compared with back beliefs questionnaire - a 14-tem questionnaire on a 0-5 scale	Day 0
Correlation of the French questionnaire score with fear avoidance beliefs	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	Day 0
Correlation of the French questionnaire score with kinesiophobia	FreBAQ score compared with Tampa scale of Kinesiophobia - total score 68, with a cut-off of 40 for significant kinesiophobia	Day 0
Correlation of the French questionnaire score with catastrophism	FreBAQ score compared with Pain Catastrophizing Scale - a 13-item questionnaire on a 0-4 Likert scale	Day 0
Correlation of the French questionnaire score with anxiety and depression	FreBAQ score compared with Hospital Anxiety and Depression Scale - a 14-item questionnaire on a 0-9 Likert scale	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NIMAO/2020-2/AH-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No