An interventional study of Assessment of disability and behavior (by questionnaires) in Musculoskeletal Pain, Musculoskeletal Pain Disorder and Fear of Pain, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Hasselt University · Not applicable, Interventional, and Diagnostic
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.
511 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 100 is above the median of 66 across 358 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Hasselt University is the lead sponsor of 203 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for all patients
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)
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)
The fear-avoidance component scale (FACS)
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
Time frame: day 0
The fear-avoidance component scale (FACS)
Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day 7
Fear-avoidance beliefs questionnaire
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Time frame: day 0
Fear-avoidance beliefs questionnaire
3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)
Time frame: day 7
Tampa scale for kinesiophobia
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Time frame: day 0
Tampa scale for kinesiophobia
Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68
Time frame: day 7
Pain catastrophizing scale
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Time frame: day 0
Pain catastrophizing scale
Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day 7
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2019 to primary completion in Jun 2022, 34 months.
Of 213 non-industry interventional studies with no phase under Musculoskeletal Pain, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 34 months is above that.
Counting every sponsor, half of 226 studies reached it within 12 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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