Clinical trial NCT05217017: French Version of Fear-Avoidance Component Scale (FACS-FR)
Official title: Psychometric Validation of the French Version of the Fear Avoidance Component Scale (FACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kinesiophobia
Chronic Pain
Keywords: Kinesiophobia
Chronic Pain
Fear-avoidance
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: FACS
timeFrame: day 0
measure: FACS
timeFrame: day 7
measure: TSK
timeFrame: day 0
measure: PCS
timeFrame: day 0
measure: HADS
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du CHUS (CRCHUS)
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Guillaume Leonard, Pr
role: STUDY_DIRECTOR
References: