Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pre-test of French version of FreBAQ on 20 representative patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient pregnant, parturient or breastfeeding
结局指标
主要结局
Pre-test of French version of FreBAQ on 20 representative patients
时间窗: 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)
次要结局
- Assessment of the reproducibility (test-retest) of the questionnaire in French(Day 7)
- Correlation of the French questionnaire score with catastrophism(Day 0)
- Evaluation of the internal consistency of the French version of the FreBAQ(Day 0)
- Assessment of the reliability (test-retest) of the questionnaire in French(Day 7)
- Assessment of the concurrent validity(Day 0)
- Correlation of the French questionnaire score with fear avoidance beliefs(Day 0)
- Correlation of the French questionnaire score with kinesiophobia(Day 0)
- Correlation of the French questionnaire score with disability(Day 0)
- Correlation of the French questionnaire score with false beliefs(Day 0)
- FreBAQ score in a subgroup of 50 subjects (35 patients and 15 controls)(Day 7)
- Assessment of the discriminant validity of the questionnaire in French(Day 0)
- Evaluation of the unidimensionality of the French version of the FreBAQ(Day 0)
- Correlation of the French questionnaire score with lumbar VAS in movement(Day 0)
- Correlation of the French questionnaire score with anxiety and depression(Day 0)
- FreBAQ score(Day 0)
- Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest(Day 0)