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

Low Back Pain Clinical Trial

— FreBAQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931758
• Other study ID #: NIMAO/2020-2/AH-1
• Status: Completed
• Start date: May 23, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Evaluation of the internal consistency of the French version of the FreBAQ	Analyzed by calculating Cronbach's alpha.	Day 0
Secondary	Evaluation of the unidimensionality of the French version of the FreBAQ	Analyzed using principal component analysis methods	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of the concurrent validity	Correlation of the French questionnaire score with the duration of low back pain	Day 0
Secondary	Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest	FreBAQ score compared with VAS result	Day 0
Secondary	Correlation of the French questionnaire score with lumbar VAS in movement	FreBAQ score compared with VAS result	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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