NCT04545853

Brief Summary

The aim of this study is to investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

September 4, 2020

Last Update Submit

December 10, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Movement-evoked pain

    Pain that is experienced in response to a physical task. Participants will perform a lifting task. Participants will be asked to lift a series of 19-canisters that will be arranged in a standardized pattern on a waist-high table. Participants will provide a pain rating on a 11 points Numeric Rating Scale (NRS) with the endpoints no pain" (0) and "excruciating pain" (10)

    Assessed only once at baseline.

  • Illness perceptions

    The illness perception questionnaire-revised (IPQ-R) will be used to measure patients' illness perceptions. In the first domain, called illness identity, the perceived symptoms and their possible relation to the illness are evaluated. In this study, participants will indicate whether or not they believe that a specific symptom is related to pain ("yes" or "no"). The second domain, the beliefs domain, covers 7 dimensions: the acute/chronic timeline, the cyclical character of the illness, the consequences, controllability, curability, emotional representations and illness coherence. The third domain lists 18 possible causes to which individuals attribute their condition, the degree to which individuals perceive themselves as responsible for the illness, as well as the responsibility individuals take for curing themselves. For each item in the second and third domain, patients rate their level of agreement on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree"

    Assessed only once at baseline

  • Pain catastrophizing

    The Pain Catastrophizing Scale (PCS) is a questionnaire to objectify catastrophic thinking about pain. It consists of 13 items describing different thoughts and feelings that individuals may have when experiencing pain. Items are scored on a 5-point scale. A general score and scores on 3 subscales (i.e., helplessness (6 items), magnification (3 items), and rumination (4items)) will be obtained; higher scores indicate more severe catastrophic thoughts about pain

    Assessed only once at baseline

  • Attention to pain

    The Pain Vigilance and Awareness Questionnaire (PVAQ) will be used to investigate patients' attention to pain. It is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain. Scores range from 0 to 80 and high scores correspond to hypervigilance for pain.

    Assessed only once at baseline

  • Fear of injury due to movement

    The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that will be used to measure the fear of (re) injury due to movement. Scores range from 17 to 68, with scores ≤ 37 suggesting low fear of movement and scores \> 37 indicating high fear of movement.

    Assessed only once at baseline

  • Quality of life, an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.

    The 36-item short form health survey (SF-36) is a multidimensional generic questionnaire assessing quality of life, which consists of 8 dimensions: physical functioning (10 items), role constraint caused by physical health problems (4 items), bodily pain (2 items), general health (5 items), vitality (4 items), social functioning (2 items), role constraint caused by emotional problems (3 items) and mental health (5 items). Higher scores reflecting a better health condition

    Assessed only once at baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be recruited by flyers at the University Hospital Brussels, social media. Prior to inviting the eligible participants, the presence of musculoskeletal pain will be confirmed by phone in order to proceed to the informed consent process. Musculoskeletal pain is defined as pain, that potential participants report, feeling in the muscles, joints or bones. This pain can be localized, regional, or widespread.

You may qualify if:

  • years or older,
  • presence of musculoskeletal pain for more than three months,
  • medically stable (no serious health conditions, no pending surgery or invasive medical procedure, no contraindication to physical activity).

You may not qualify if:

  • Presence of co-existing pain conditions of other origins with chronic musculoskeletal pain not being the primary condition (i.e. predominant subject of symptom complaints)
  • severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.)
  • pregnant or given birth in the preceding year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 11, 2020

Study Start

October 1, 2020

Primary Completion

May 15, 2021

Study Completion

June 1, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12