Musculoskeletal PainNCT03994861
Dutch Version Fear-Avoidance Component Scale (FACS)
A study testing Assessment of disability and behavior (by questionnaires) in people with Musculoskeletal Pain and Musculoskeletal Pain Disorder, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Musculoskeletal Pain Disorder, Fear of Pain
- What is being tested?
- Assessment of disability and behavior (by questionnaires)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2019to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Musculoskeletal Pain, Musculoskeletal Pain Disorder, Fear of Pain, Fear of Injury, Low Back Pain, Recurrent, Neck Pain
- Being tested
- Assessment of disability and behavior (by questionnaires)
- Medical subject headings
- Musculoskeletal Pain, Collagen Diseases, Low Back Pain, Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of disability and behavior (by questionnaires)Diagnostic test
Assessment of disability and behavior (by questionnaires)
| Study group | Role | What they receive |
|---|---|---|
| Patients with musculoskeletal disorders | Active comparator | 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 Receives: Diagnostic Test: Assessment of disability and behavior (by questionnaires) |
| Healthy controls | Sham comparator | Age- and gender-matched healthy controls (without musculoskeletal pain) Receives: Diagnostic Test: Assessment of disability and behavior (by questionnaires) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fear-avoidance component scale (FACS)
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
Measured: day 0
The fear-avoidance component scale (FACS)
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
Measured: day 7
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
Measured: day 0
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
Measured: day 7
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)
Measured: day 0
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)
Measured: day 7
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
Measured: day 0
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
Measured: day 7
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
Measured: day 0
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
Measured: day 7
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
Measured: day 0
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
Measured: day 7
Fear-avoidance beliefs questionnaire
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Measured: day 0
Fear-avoidance beliefs questionnaire
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Measured: day 7
Tampa scale for kinesiophobia
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Measured: day 0
Tampa scale for kinesiophobia
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Measured: day 7
Pain catastrophizing scale
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Measured: day 0
Pain catastrophizing scale
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Measured: day 7
IEQ-Dutch scale for perceived injustice
Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48
Measured: day 0
IEQ-Dutch scale for perceived injustice
Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48
Measured: day 7
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
Measured: day 0
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
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with musculoskeletal disorders are compared to matched healthy controls.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Lotte Janssens, Hasselt University
- Investigators
- Annick Timmermans, PhD, PT, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994861
- Sponsor's protocol ID
- 18.61/REVA18.02
- Status last verified
- Sep 2023
- First submitted
- 4 Jun 2019
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reliability of the Dutch Version of the Fear-Avoidance Component Scale (FACS)
- ClinicalTrials.gov ID
- NCT03994861
- Acronym / sponsor ID
- 18.61/REVA18.02
- Conditions
- Musculoskeletal Pain, Musculoskeletal Pain Disorder, Fear of Pain, Fear of Injury, Low Back Pain, Recurrent, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients with musculoskeletal disorders are compared to matched healthy controls.
| Arm | Type | Receives |
|---|---|---|
| Patients with musculoskeletal disorders | Active comparator | Diagnostic Test: Assessment of disability and behavior (by questionnaires)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 |
| Healthy controls | Sham comparator | Diagnostic Test: Assessment of disability and behavior (by questionnaires)Age- and gender-matched healthy controls (without musculoskeletal pain) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of disability and behavior (by questionnaires)Assessment of disability and behavior (by questionnaires) | Diagnostic test | Healthy controls, Patients with musculoskeletal disorders |
Primary outcome
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
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
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
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
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)
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)
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
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
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
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
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
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
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)
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)
Tampa scale for kinesiophobia
Time frame: day 0
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Tampa scale for kinesiophobia
Time frame: day 7
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Pain catastrophizing scale
Time frame: day 0
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Pain catastrophizing scale
Time frame: day 7
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annick Timmermans, PhD, PT principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of disability and behavior (by questionnaires) in people with Musculoskeletal Pain and Musculoskeletal Pain Disorder, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fear-avoidance component scale (FACS) (time frame: day 0). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.