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Dutch Version Fear-Avoidance Component Scale (FACS)

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ClinicalTrials.gov Identifier: NCT03994861
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Lotte Janssens, Hasselt University

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.

Condition or disease Intervention/treatment Phase
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 Diagnostic Test: Assessment of disability and behavior (by questionnaires) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with musculoskeletal disorders are compared to matched healthy controls.
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Validation and Reliability of the Dutch Version of the Fear-Avoidance Component Scale (FACS)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

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)




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994861


Contacts
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Contact: Liesbet De Baets, PhD, PT +3211286939 Liesbet.DeBaets@uhasselt.be
Contact: Lotte Janssens, PhD, PT +3211292174 LotteJanssens@uhasselt.be

Locations
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Belgium
Lotte Janssens Recruiting
Hasselt, Belgium, 3590
Contact: Lotte Janssens    474435639    Lotte.Janssens@uhasselt.be   
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Annick Timmermans, PhD, PT Hasselt University
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Responsible Party: Lotte Janssens, Prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT03994861    
Other Study ID Numbers: 18.61/REVA18.02
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Musculoskeletal Pain
Rheumatic Diseases
Collagen Diseases
Back Pain
Low Back Pain
Neck Pain
Somatoform Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Mental Disorders
Connective Tissue Diseases