Low Back Pain
Conditions
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.
Interventions
OTHERPain 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
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-test of French version of FreBAQ on 20 representative patients | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FreBAQ score in a subgroup of 50 subjects (35 patients and 15 controls) | Day 7 | 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) |
| Evaluation of the internal consistency of the French version of the FreBAQ | Day 0 | Analyzed by calculating Cronbach's alpha. |
| Evaluation of the unidimensionality of the French version of the FreBAQ | Day 0 | Analyzed using principal component analysis methods |
| Assessment of the reliability (test-retest) of the questionnaire in French | Day 7 | 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, |
| Assessment of the reproducibility (test-retest) of the questionnaire in French | Day 7 | 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 |
| Assessment of the discriminant validity of the questionnaire in French | Day 0 | Comparison of scores between control subjects and chronic low back pain patients by calculating the area under the ROC curve |
| Assessment of the concurrent validity | Day 0 | Correlation of the French questionnaire score with the duration of low back pain |
| FreBAQ score | Day 0 | 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) |
| Correlation of the French questionnaire score with lumbar VAS in movement | Day 0 | FreBAQ score compared with VAS result |
| Correlation of the French questionnaire score with disability | Day 0 | FreBAQ score compared with Oswestry Disability Index - a 10-section questionnaire with a results calculated as a percentage |
| Correlation of the French questionnaire score with false beliefs | Day 0 | FreBAQ score compared with back beliefs questionnaire - a 14-tem questionnaire on a 0-5 scale |
| Correlation of the French questionnaire score with fear avoidance beliefs | Day 0 | 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 |
| Correlation of the French questionnaire score with kinesiophobia | Day 0 | FreBAQ score compared with Tampa scale of Kinesiophobia - total score 68, with a cut-off of 40 for significant kinesiophobia |
| Correlation of the French questionnaire score with catastrophism | Day 0 | FreBAQ score compared with Pain Catastrophizing Scale - a 13-item questionnaire on a 0-4 Likert scale |
| Correlation of the French questionnaire score with anxiety and depression | Day 0 | FreBAQ score compared with Hospital Anxiety and Depression Scale - a 14-item questionnaire on a 0-9 Likert scale |
| Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest | Day 0 | FreBAQ score compared with VAS result |
Countries
France
Outcome results
None listed