Musculoskeletal PainNCT04545853
Associations Between Pain Perceptions and Movement-evoked Pain.
An observational study of Musculoskeletal Pain, run by Vrije Universiteit Brussel.
Trial summary
The aim of this study is to investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Jun 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 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).
Who cannot join
- 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.
About this study
Official title: Associations Between Pain Perceptions and Movement-evoked Pain: a Cross-sectional Study.
The aim of this study is to investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints.
Read the detailed description
This study will investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints. This study will be carried out as a cross-sectional study. Participants will be recruited by means of flyers and social media.
Pain cognitions will be assessed using questionnaires (The Pain Catastrophizing Scale (PCS), The llness perception questionnaire-revised (IPQ-R), The Pain Vigilance and Awareness Questionnaire (PVAQ), The Tampa Scale for Kinesiophobia (TSK), The 36-item short form health survey (SF-36)), whilst movement-evoked pain will be assessed using a lifting task. Participants will need to rate the experienced pain immediately after completing the task. To estimate the extent to which pain cognitions explain movement-evoked pain, correlational analyses will first be conducted between all variables to determine what variables will be included in the hierarchical regression analysis.
- Conditions
- Musculoskeletal Pain
- Medical subject headings
- Musculoskeletal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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"
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Assessed only once at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Oct 2020
- Primary completion15 May 2021
- Study completion1 Jun 2021
Why it stopped: Due to COVID-19
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn Leemans, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545853
- Sponsor's protocol ID
- MEP_PC
- Status last verified
- Dec 2021
- First submitted
- 4 Sep 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Pain Perceptions and Movement-evoked Pain: a Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT04545853
- Acronym / sponsor ID
- MEP_PC
- Conditions
- Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 11 Sep 2020 (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.
The aim of this study is to investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints.
Detailed description
This study will investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints. This study will be carried out as a cross-sectional study. Participants will be recruited by means of flyers and social media.
Pain cognitions will be assessed using questionnaires (The Pain Catastrophizing Scale (PCS), The llness perception questionnaire-revised (IPQ-R), The Pain Vigilance and Awareness Questionnaire (PVAQ), The Tampa Scale for Kinesiophobia (TSK), The 36-item short form health survey (SF-36)), whilst movement-evoked pain will be assessed using a lifting task. Participants will need to rate the experienced pain immediately after completing the task. To estimate the extent to which pain cognitions explain movement-evoked pain, correlational analyses will first be conducted between all variables to determine what variables will be included in the hierarchical regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Movement-evoked pain
Time frame: Assessed only once at baseline.
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)
Illness perceptions
Time frame: Assessed only once at baseline
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"
Pain catastrophizing
Time frame: Assessed only once at baseline
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
Attention to pain
Time frame: Assessed only once at baseline
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.
Fear of injury due to movement
Time frame: Assessed only once at baseline
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.
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.
Time frame: Assessed only once at baseline
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by Vrije Universiteit Brussel.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Movement-evoked pain (time frame: Assessed only once at baseline.). The study lists 6 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 3 Jan 2022.