Dutch Version Fear-Avoidance Component Scale (FACS)

Validation and Reliability of the Dutch Version of the Fear-Avoidance Component Scale (FACS)

Chronic musculoskeletal disorders such as low back and neck pain are responsible for an enormous global burden. Fear-avoidance (FA) can be a predictor for the transition from subacute to chronic low back pain. In patients with neck pain, those who were less fearful about harming their neck, had higher pain tolerance, which might have a positive impact on their level of disability. A new scale, the Fear-Avoidance Component Scale (FACS) was developed by Neblett, Mayer, Hartzell, Williams and Gatchel (2015) to assess FA. It consists of an all-encompassing set of constructs that more effectively deals with all critical issues of the FA concept than current scales do. Current scales have been criticized because of following findings: limited construct validity, little evidence on treatment responsiveness, a lack of evidence-based cut-off scores and items being too narrow or too general. The new scale comprehensively assesses all cognitive, emotional and behavioral components related to the updated version of the FA model by combining items of well-known scales in context of the FA model with items on one's perception of victimization and blame related to an injury. A Dutch version of the FACS is currently lacking. Subsequently, the aim of this study is to investigate different psychometric properties of the generated Dutch version in patients with musculoskeletal disorders.

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Musculoskeletal Pain; Neck Pain; Low Back Pain, Recurrent; Shoulder Pain; PROMs; Fear of Pain; Musculoskeletal Pain Disorder; Knee Pain Chronic; Fear of Injury
• Intervention / Treatment: Diagnostic test: Assessment of disability and behavior (by questionnaires)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liesbet De Baets, PhD, PT; Phone Number: +3211286939; Email: Liesbet.DeBaets@uhasselt.be
• Study Contact Backup: Name: Lotte Janssens, PhD, PT; Phone Number: +3211292174; Email: LotteJanssens@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3590
    • Lotte Janssens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria for all patients

• between 18-80 years old
• current pain complaint is not surgically treated
• not being currently treated by a physiotherapist for pain complaint
• Dutch language is mother tongue
• At least 6 weeks of pain Exclusion criteria for all patients
• Pain from a non-musculoskeletal origin (e.g., tumour)
• neurological disease
• impaired cognition Inclusion criteria for healthy controls
• Not being disabled due to MSK pain based on cut-off per disability questionnaire
• Between 18-80 years old
• Dutch language is mother tongue

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with musculoskeletal disorders; Patients with either shoulder pain, knee pain, hip pain, low back pain, pelvic pain or neck pain as their primary pain complaint, lasting for 6 weeks or longer	Diagnostic test: Assessment of disability and behavior (by questionnaires); Assessment of disability and behavior (by questionnaires)
Sham Comparator: Healthy controls; Age- and gender-matched healthy controls (without musculoskeletal pain)	Diagnostic test: Assessment of disability and behavior (by questionnaires); Assessment of disability and behavior (by questionnaires)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The fear-avoidance component scale (FACS)	Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100	day 0
The fear-avoidance component scale (FACS)	Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100	day 7
Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients	Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale	day 0
Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients	Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale	day 7
Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients	Questionnaire evaluating disability (only used in patients with hip pain) Subscores per domain 40 items 5 point scale 5 domains: symptoms (5 items), pain (10 items), activities of daily living (17 items), sport and leisure time (4 items), quality of life (4 items)	day 0
Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients	Questionnaire evaluating disability (only used in patients with hip pain) Subscores per domain 40 items 5 point scale 5 domains: symptoms (5 items), pain (10 items), activities of daily living (17 items), sport and leisure time (4 items), quality of life (4 items)	day 7
Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients	Questionnaire evaluating disability (only used in patients with knee pain) Subscores per domain 42 items 5 domains: pain (9 items), symptoms (7 items), activities of daily life (17 items), sports and leisure (5 items), quality of life (4 items) 5 point Likert scale	day 0
Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients	Questionnaire evaluating disability (only used in patients with knee pain) Subscores per domain 42 items 5 domains: pain (9 items), symptoms (7 items), activities of daily life (17 items), sports and leisure (5 items), quality of life (4 items) 5 point Likert scale	day 7
Oswestry Disability Index for patients with low back pain	Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100	day 0
Oswestry Disability Index for patients with low back pain	Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100	day 7
Neck Disability Index for neck pain patients	Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100	day 0
Neck Disability Index for neck pain patients	Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100	day 7
Fear-avoidance beliefs questionnaire	3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)	day 0
Fear-avoidance beliefs questionnaire	3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)	day 7
Tampa scale for kinesiophobia	Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68	day 0
Tampa scale for kinesiophobia	Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68	day 7
Pain catastrophizing scale	Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52	day 0
Pain catastrophizing scale	Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52	day 7
IEQ-Dutch scale for perceived injustice	Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48	day 0
IEQ-Dutch scale for perceived injustice	Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48	day 7
Hospital anxiety and depression scale	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
Hospital anxiety and depression scale	Questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale	day 7

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital
• Investigators: Principal Investigator: Annick Timmermans, PhD, PT, Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Arthralgia; Back Pain; Low Back Pain; Neck Pain; Shoulder Pain; Somatoform Disorders; Rheumatic Diseases; Collagen Diseases; Musculoskeletal Pain
• Other Study ID Numbers: 18.61/REVA18.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No