Dutch Version Fear-Avoidance Component Scale (FACS)

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994861
• Other study ID #: 18.61/REVA18.02
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Fear of Injury
• Fear of Pain
• Hip Pain Chronic
• Knee Pain Chronic
• Low Back Pain
• Low Back Pain, Recurrent
• Musculoskeletal Pain
• Musculoskeletal Pain Disorder
• Neck Pain
• PROMs
• Rheumatic Diseases
• Shoulder Pain
• Somatoform Disorders

Intervention

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

Locations

Country	Name	City	State
Belgium	Lotte Janssens	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The fear-avoidance component scale (FACS)	Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100	day 0
Primary	The fear-avoidance component scale (FACS)	Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100	day 7
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Fear-avoidance beliefs questionnaire	3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)	day 0
Primary	Fear-avoidance beliefs questionnaire	3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)	day 7
Primary	Tampa scale for kinesiophobia	Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68	day 0
Primary	Tampa scale for kinesiophobia	Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68	day 7
Primary	Pain catastrophizing scale	Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52	day 0
Primary	Pain catastrophizing scale	Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52	day 7
Primary	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
Primary	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
Primary	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
Primary	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