NCT03994861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

June 4, 2019

Last Update Submit

September 24, 2023

Conditions

Musculoskeletal PainMusculoskeletal Pain DisorderFear of PainFear of InjuryLow Back Pain, RecurrentNeck PainShoulder PainKnee Pain ChronicHip Pain ChronicPROMs

Outcome Measures

Primary Outcomes (22)

  • The fear-avoidance component scale (FACS)

    Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100

    day 0

  • The fear-avoidance component scale (FACS)

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100

    day 7

  • Fear-avoidance beliefs questionnaire

    3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)

    day 0

  • Fear-avoidance beliefs questionnaire

    3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)

    day 7

  • Tampa scale for kinesiophobia

    Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68

    day 0

  • Tampa scale for kinesiophobia

    Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68

    day 7

  • Pain catastrophizing scale

    Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52

    day 0

  • Pain catastrophizing scale

    Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52

    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

    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

    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

    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

    day 7

Study Arms (2)

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

Diagnostic Test: Assessment of disability and behavior (by questionnaires)

Healthy controls

SHAM COMPARATOR

Age- and gender-matched healthy controls (without musculoskeletal pain)

Diagnostic Test: Assessment of disability and behavior (by questionnaires)

Interventions

Assessment of disability and behavior (by questionnaires)DIAGNOSTIC_TEST

Assessment of disability and behavior (by questionnaires)

Healthy controlsPatients with musculoskeletal disorders

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pain from a non-musculoskeletal origin (e.g., tumour)
  • neurological disease
  • Not being disabled due to MSK pain based on cut-off per disability questionnaire
  • Between 18-80 years old
  • Dutch language is mother tongue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lotte Janssens

Hasselt, 3590, Belgium

Location

MeSH Terms

Conditions

Musculoskeletal PainCollagen DiseasesLow Back PainNeck PainShoulder Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesBack PainArthralgiaJoint Diseases

Study Officials

  • Annick Timmermans, PhD, PT

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Patients with musculoskeletal disorders are compared to matched healthy controls.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 21, 2019

Study Start

August 1, 2019

Primary Completion

June 1, 2022

Study Completion

June 1, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)