Low Back PainFreBAQNCT04931758
Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain
An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pain Questionnaire
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2022to 28 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant, parturient or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Pain Questionnaire
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with low back pain | Not described Receives: Other: Pain Questionnaire | |
| Controls | Not described Receives: Other: Pain Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (16)
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)
Measured: 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)
Measured: Day 7
Evaluation of the internal consistency of the French version of the FreBAQ
Analyzed by calculating Cronbach's alpha.
Measured: Day 0
Evaluation of the unidimensionality of the French version of the FreBAQ
Analyzed using principal component analysis methods
Measured: 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,
Measured: 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
Measured: 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
Measured: Day 0
Assessment of the concurrent validity
Correlation of the French questionnaire score with the duration of low back pain
Measured: Day 0
Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest
FreBAQ score compared with VAS result
Measured: Day 0
Correlation of the French questionnaire score with lumbar VAS in movement
FreBAQ score compared with VAS result
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start23 May 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Homs, Principal investigator, CHU Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931758
- Sponsor's protocol ID
- NIMAO/2020-2/AH-1
- Other IDs
- 2021-A00373-38
- Acronym
- FreBAQ
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2021
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40066561
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04931758
- Acronym / sponsor ID
- FreBAQ / NIMAO/2020-2/AH-1
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with low back pain | – | Other: Pain Questionnaire |
| Controls | – | Other: Pain Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (3 listed)
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant, parturient or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain QuestionnaireSubjects 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 | Other | Controls, Patients with low back pain |
Primary outcome
Pre-test of French version of FreBAQ on 20 representative patients
Time frame: Baseline
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)
16 secondary outcomes
FreBAQ score
Time frame: Day 0
FreBAQ score in a subgroup of 50 subjects (35 patients and 15 controls)
Time frame: Day 7
Evaluation of the internal consistency of the French version of the FreBAQ
Time frame: Day 0
Evaluation of the unidimensionality of the French version of the FreBAQ
Time frame: Day 0
Assessment of the reliability (test-retest) of the questionnaire in French
Time frame: Day 7
Assessment of the reproducibility (test-retest) of the questionnaire in French
Time frame: Day 7
Assessment of the discriminant validity of the questionnaire in French
Time frame: Day 0
Assessment of the concurrent validity
Time frame: Day 0
Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest
Time frame: Day 0
Correlation of the French questionnaire score with lumbar VAS in movement
Time frame: Day 0
Correlation of the French questionnaire score with disability
Time frame: Day 0
Correlation of the French questionnaire score with false beliefs
Time frame: Day 0
Correlation of the French questionnaire score with fear avoidance beliefs
Time frame: Day 0
Correlation of the French questionnaire score with kinesiophobia
Time frame: Day 0
Correlation of the French questionnaire score with catastrophism
Time frame: Day 0
Correlation of the French questionnaire score with anxiety and depression
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 40066561Homs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Homs principal investigator
CHU Nîmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-test of French version of FreBAQ on 20 representative patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04931758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.