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

Primary Purpose

Kinesiophobia, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FACS
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kinesiophobia focused on measuring Kinesiophobia, Chronic Pain, Fear-avoidance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de recherche du CHUS (CRCHUS)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic pain

Arm Description

Fear-avoidance components scale

Outcomes

Primary Outcome Measures

FACS
The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100
FACS
The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100
TSK
Questionnaire evaluating kinesiophobia (for all participants) 17 items total score from 17-68
PCS
Pain catastrophizing scale (for all participants) 13 items total score from 0-52
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

Secondary Outcome Measures

Full Information

First Posted
January 19, 2022
Last Updated
March 25, 2023
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT05217017
Brief Title
French Version of Fear-Avoidance Component Scale (FACS-FR)
Acronym
FACS-Fr
Official Title
Psychometric Validation of the French Version of the Fear Avoidance Component Scale (FACS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kinesiophobia, Chronic Pain
Keywords
Kinesiophobia, Chronic Pain, Fear-avoidance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic pain
Arm Type
Experimental
Arm Description
Fear-avoidance components scale
Intervention Type
Diagnostic Test
Intervention Name(s)
FACS
Intervention Description
Diagnostic Test: Assessment of disability and behavior (by questionnaires)
Primary Outcome Measure Information:
Title
FACS
Description
The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100
Time Frame
day 0
Title
FACS
Description
The fear-avoidance component scale evaluating fear-avoidance (for all participants) 20 items range from 0-100
Time Frame
day 7
Title
TSK
Description
Questionnaire evaluating kinesiophobia (for all participants) 17 items total score from 17-68
Time Frame
day 0
Title
PCS
Description
Pain catastrophizing scale (for all participants) 13 items total score from 0-52
Time Frame
day 0
Title
HADS
Description
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
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Leonard, Pr
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
Facility Information:
Facility Name
Centre de recherche du CHUS (CRCHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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