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临床试验/NCT05217017
NCT05217017已完成不适用

Psychometric Validation of the French Version of the Fear Avoidance Component Scale (FACS)

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
FACS

研究概览

简要总结

Chronic musculoskeletal disorders are global burden for economy. Fear-avoidance (FA) seems be a predictor for the transition from subacute to chronic pain. One of the most famous scales to access FA is the Tampa scale of kinesiophobia, but several responders think some items are not clear, too narrow or too general. A new scale, the Fear-Avoidance Components Scale (FACS) was developed by Neblett et al. in 2015 to assess FA. It is a comprehensive set of concepts that more effectively addresses all the essential issues of the FA concept than the current scales. The new scale comprehensively assesses all cognitive, emotional, and behavioral components related to the updated FA model by combining items from well-known scales in the context of the FA model with items on perceived injury-related victimization and blame. A French version of the FACS is currently lacking. The aim of this study is to provide a translation and validation of a French version of FACS in patients with musculoskeletal disorders.

详细描述

The process is done in two steps to allow the achievement of our two study objectives (translation and validation), with two different cohorts of patients.

First, for the French translation of the FACS, a pre-test with a first cohort of 30 patients will be performed. These patients will have to fill in the French version of the paper questionnaire and answer a second one on their interpretation and understanding of the questions. Each question will be evaluated by the patient. A report will be made with the patients' answers to the questionnaire and reported to the translation committee, then modifications will be made to the translation if necessary. If changes are made, a second pre-test will be done until no changes are needed.

In a second phase, once the French version is finalized, the second cohort of 50 patients will follow the patient schedule presented in Table I. In more detail, at the initial consultation, the diagnosis of chronic pain should be made by the center's orthopedist. At the same time, the orthopedist, resident, or research assistant will validate, through free and informed consent, whether or not the patient agrees to participate in the study, i.e., T0. At this T0, the patient will have to fill out the four questionnaires, which are FACS, Tampa scale for kinesiophobia French Canadian version (EKT-CF), Pain catastrophizing scale French Canadian version (PCS-CF) and Hospital anxiety and depression scale French version (HADS). The questionnaires will be completed in paper form.

At T1, i.e. seven days later, the patient will have to take the FACS French version again on the REDcap platform. This time frame is short enough to allow for a similar or even identical state of function as at T0 for the assessment of test-retest reliability. Patients with a significant change in status will be excluded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least 18 years old
  • •Current chronic pain complaint is not surgically treated (at least 6 weeks of pain)
  • •Not being currently treated by a physiotherapist for pain complaint
  • •French language is mother tongue

排除标准

  • •Pain from a non-musculoskeletal origin (e.g., tumour)
  • •Neurological disease
  • •Impaired cognition

研究组 & 干预措施

Chronic pain

Experimental

Fear-avoidance components scale

干预措施: FACS (Diagnostic Test)

结局指标

主要结局

FACS

时间窗: day 7

The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100

TSK

时间窗: day 0

Questionnaire evaluating kinesiophobia (for all participants) 17 items total score from 17-68

PCS

时间窗: day 0

Pain catastrophizing scale (for all participants) 13 items total score from 0-52

HADS

时间窗: day 0

Hospital anxiety and depression scale is a questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale

FACS

时间窗: day 0

The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillaume Léonard

Professor

Université de Sherbrooke

研究点 (1)

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