French Version of Fear-Avoidance Component Scale (FACS-FR)

Chronic Pain Clinical Trial

— FACS-Fr  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217017
• Other study ID #: 2022-4356b
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: March 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Kinesiophobia

Intervention

Diagnostic Test:
• FACS
Diagnostic Test: Assessment of disability and behavior (by questionnaires)

Locations

Country	Name	City	State
Canada	Centre de recherche du CHUS (CRCHUS)	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACS	The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100	day 0
Primary	FACS	The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100	day 7
Primary	TSK	Questionnaire evaluating kinesiophobia (for all participants) 17 items total score from 17-68	day 0
Primary	PCS	Pain catastrophizing scale (for all participants) 13 items total score from 0-52	day 0
Primary	HADS	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	day 0