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

NCT ID: NCT04931758

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-23

Study Completion Date

2023-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with low back pain

Pain Questionnaire

Intervention Type 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

Pain Questionnaire

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexis Homs

Role: PRINCIPAL_INVESTIGATOR

CHU Nîmes

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Nîmes

Nîmes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 40066561 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A00373-38

Identifier Type: OTHER

Identifier Source: secondary_id

NIMAO/2020-2/AH-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spinal Kinematics Variability
NCT03507296 COMPLETED