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Completed

NCT Number: NCT03994861

Dutch Version 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.

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Key information

Conditions

Musculoskeletal Pain Arthralgia Back Pain Collagen Diseases Connective Tissue Diseases Fear of Injury Fear of Pain Hip Pain Chronic Joint Diseases Knee Pain Chronic Low Back Pain Low Back Pain, Recurrent Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Disorder Neck Pain Neurologic Manifestations PROMs Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lotte Janssens

Hasselt, 3590, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of disability and behavior (by questionnaires)

Diagnostic Test

Assessment of disability and behavior (by questionnaires)

Primary outcomes

  1. The fear-avoidance component scale (FACS)

    Time frame: day 0

    Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100

  2. The fear-avoidance component scale (FACS)

    Time frame: day 7

    Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100

  3. Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients

    Time frame: day 0

    Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale

  4. Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients

    Time frame: day 7

    Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale

  5. Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients

    Time frame: day 0

    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)

  6. Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients

    Time frame: day 7

    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)

  7. Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients

    Time frame: day 0

    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

  8. Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients

    Time frame: day 7

    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

  9. Oswestry Disability Index for patients with low back pain

    Time frame: day 0

    Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100

  10. Oswestry Disability Index for patients with low back pain

    Time frame: day 7

    Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100

  11. Neck Disability Index for neck pain patients

    Time frame: day 0

    Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100

  12. Neck Disability Index for neck pain patients

    Time frame: day 7

    Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100

  13. Fear-avoidance beliefs questionnaire

    Time frame: day 0

    3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)

  14. Fear-avoidance beliefs questionnaire

    Time frame: day 7

    3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)

  15. Tampa scale for kinesiophobia

    Time frame: day 0

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

  16. Tampa scale for kinesiophobia

    Time frame: day 7

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

  17. Pain catastrophizing scale

    Time frame: day 0

    Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52

  18. Pain catastrophizing scale

    Time frame: day 7

    Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52

  19. IEQ-Dutch scale for perceived injustice

    Time frame: day 0

    Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48

  20. IEQ-Dutch scale for perceived injustice

    Time frame: day 7

    Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48

  21. Hospital anxiety and depression scale

    Time frame: day 0

    Questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale

  22. Hospital anxiety and depression scale

    Time frame: day 7

    Questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jun 21, 2019
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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