Clinical trial NCT03994861: Dutch Version Fear-Avoidance Component Scale (FACS)
Official title: Validation and Reliability of the Dutch Version of the Fear-Avoidance Component Scale (FACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Musculoskeletal Pain Disorder
Fear of Pain
Fear of Injury
Low Back Pain, Recurrent
Neck Pain
Shoulder Pain
Knee Pain Chronic
Hip Pain Chronic
PROMs
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2019-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with musculoskeletal disorders are compared to matched healthy controls.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The fear-avoidance component scale (FACS)
timeFrame: day 0
measure: The fear-avoidance component scale (FACS)
timeFrame: day 7
measure: Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients
timeFrame: day 0
measure: Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients
timeFrame: day 7
measure: Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients
timeFrame: day 0
measure: Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients
timeFrame: day 7
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients
timeFrame: day 0
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients
timeFrame: day 7
measure: Oswestry Disability Index for patients with low back pain
timeFrame: day 0
measure: Oswestry Disability Index for patients with low back pain
timeFrame: day 7
measure: Neck Disability Index for neck pain patients
timeFrame: day 0
measure: Neck Disability Index for neck pain patients
timeFrame: day 7
measure: Fear-avoidance beliefs questionnaire
timeFrame: day 0
measure: Fear-avoidance beliefs questionnaire
timeFrame: day 7
measure: Tampa scale for kinesiophobia
timeFrame: day 0
measure: Tampa scale for kinesiophobia
timeFrame: day 7
measure: Pain catastrophizing scale
timeFrame: day 0
measure: Pain catastrophizing scale
timeFrame: day 7
measure: IEQ-Dutch scale for perceived injustice
timeFrame: day 0
measure: IEQ-Dutch scale for perceived injustice
timeFrame: day 7
measure: Hospital anxiety and depression scale
timeFrame: day 0
measure: Hospital anxiety and depression scale
timeFrame: day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Lotte Janssens
Study officials:
affiliation: Hasselt University
name: Annick Timmermans, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: