Dutch Version Fear-Avoidance Component Scale (FACS)
Primary Purpose
Musculoskeletal Pain, Musculoskeletal Pain Disorder, Fear of Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Assessment of disability and behavior (by questionnaires)
Sponsored by
About this trial
This is an interventional diagnostic trial for Musculoskeletal Pain
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
Sites / Locations
- Lotte Janssens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Patients with musculoskeletal disorders
Healthy controls
Arm Description
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
Age- and gender-matched healthy controls (without musculoskeletal pain)
Outcomes
Primary Outcome Measures
The fear-avoidance component scale (FACS)
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
The fear-avoidance component scale (FACS)
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
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
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
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)
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)
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
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
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
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
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
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
Fear-avoidance beliefs questionnaire
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Fear-avoidance beliefs questionnaire
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Tampa scale for kinesiophobia
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Tampa scale for kinesiophobia
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Pain catastrophizing scale
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Pain catastrophizing scale
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
IEQ-Dutch scale for perceived injustice
Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48
IEQ-Dutch scale for perceived injustice
Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03994861
First Posted
June 4, 2019
Last Updated
September 24, 2023
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03994861
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with musculoskeletal disorders are compared to matched healthy controls.
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with musculoskeletal disorders
Arm Type
Active Comparator
Arm Description
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
Arm Title
Healthy controls
Arm Type
Sham Comparator
Arm Description
Age- and gender-matched healthy controls (without musculoskeletal pain)
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of disability and behavior (by questionnaires)
Intervention Description
Assessment of disability and behavior (by questionnaires)
Primary Outcome Measure Information:
Title
The fear-avoidance component scale (FACS)
Description
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
Time Frame
day 0
Title
The fear-avoidance component scale (FACS)
Description
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
Time Frame
day 7
Title
Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients
Description
Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale
Time Frame
day 0
Title
Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients
Description
Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale
Time Frame
day 7
Title
Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients
Description
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)
Time Frame
day 0
Title
Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients
Description
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)
Time Frame
day 7
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients
Description
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
Time Frame
day 0
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients
Description
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
Time Frame
day 7
Title
Oswestry Disability Index for patients with low back pain
Description
Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100
Time Frame
day 0
Title
Oswestry Disability Index for patients with low back pain
Description
Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100
Time Frame
day 7
Title
Neck Disability Index for neck pain patients
Description
Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100
Time Frame
day 0
Title
Neck Disability Index for neck pain patients
Description
Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100
Time Frame
day 7
Title
Fear-avoidance beliefs questionnaire
Description
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Time Frame
day 0
Title
Fear-avoidance beliefs questionnaire
Description
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Time Frame
day 7
Title
Tampa scale for kinesiophobia
Description
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Time Frame
day 0
Title
Tampa scale for kinesiophobia
Description
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Time Frame
day 7
Title
Pain catastrophizing scale
Description
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Time Frame
day 0
Title
Pain catastrophizing scale
Description
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Time Frame
day 7
Title
IEQ-Dutch scale for perceived injustice
Description
Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48
Time Frame
day 0
Title
IEQ-Dutch scale for perceived injustice
Description
Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48
Time Frame
day 7
Title
Hospital anxiety and depression scale
Description
Questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale
Time Frame
day 0
Title
Hospital anxiety and depression scale
Description
Questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale
Time Frame
day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annick Timmermans, PhD, PT
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotte Janssens
City
Hasselt
ZIP/Postal Code
3590
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dutch Version Fear-Avoidance Component Scale (FACS)
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