NCT05217017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

January 19, 2022

Last Update Submit

March 25, 2023

Conditions

Keywords

KinesiophobiaChronic PainFear-avoidance

Outcome Measures

Primary Outcomes (5)

  • FACS

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

    day 0

  • FACS

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

    day 7

  • TSK

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

    day 0

  • PCS

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

    day 0

  • 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

Study Arms (1)

Chronic pain

EXPERIMENTAL

Fear-avoidance components scale

Diagnostic Test: FACS

Interventions

FACSDIAGNOSTIC_TEST

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

Chronic pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche du CHUS (CRCHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

KinesiophobiaChronic Pain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guillaume Leonard, Pr

    Université de Sherbrooke

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 1, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations