Dutch Version Fear-Avoidance Component Scale (FACS)

September 24, 2023 updated by: Lotte Janssens, Hasselt University

Validation and Reliability of the Dutch Version of the 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Hasselt, Belgium, 3590
        • Lotte Janssens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
day 0
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
day 7
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
day 0
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
day 7
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)
day 0
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)
day 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
day 0
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
day 7
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
day 0
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
day 7
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
day 0
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
day 7
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)
day 0
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)
day 7
Tampa scale for kinesiophobia
Time Frame: day 0
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
day 0
Tampa scale for kinesiophobia
Time Frame: day 7
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
day 7
Pain catastrophizing scale
Time Frame: day 0
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
day 0
Pain catastrophizing scale
Time Frame: day 7
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
day 7
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
day 0
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
day 7
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
day 0
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
day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jessa Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Annick Timmermans, PhD, PT, Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18.61/REVA18.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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