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

NCT04931758 | Completed

• 2 other identifiers: NIMAO/2020-2/AH-12021-A00373-38
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• FreBAQ score

  Day 0

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

  Day 7

• Evaluation of the internal consistency of the French version of the FreBAQ

  Day 0

• Evaluation of the unidimensionality of the French version of the FreBAQ

  Day 0

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

  Day 7

Study Arms (2)

Patients with low back pain

Other: Pain Questionnaire

Controls

Other: Pain Questionnaire

Interventions

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

Controls; Patients with low back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

Location

Related Publications (1)

• Homs AF, Ragon A, Mura T, Terribile G, Alonso S, Dupeyron AF. Validation of the French version of the Fremantle Back Awareness Questionnaire in patients with chronic low back pain. Eur J Phys Rehabil Med. 2025 Apr;61(2):295-304. doi: 10.23736/S1973-9087.24.08412-0. Epub 2025 Mar 10.

  PMID: 40066561 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexis Homs

  CHU Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 18, 2021
• Study Start: May 23, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)