xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06019403</url>
    </required_header>
    <id_info>
      <org_study_id>MUSKULO PAIN</org_study_id>
      <nct_id>NCT06019403</nct_id>
    </id_info>
    <brief_title>Association Between a Healthy Lifestyle Behavior and Musculoskeletal Pain</brief_title>
    <official_title>Association Between a Healthy Lifestyle Behavior and Musculoskeletal Pain: an Online Cross-sectional Survey</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université Catholique de Louvain</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fonds National de la Recherche Scientifique</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Université Catholique de Louvain</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Objective: The aim of this online cross-sectional survey is to determine the association&#xD;
        between a combination of lifestyle factors and the presence of musculoskeletal pain (neck&#xD;
        pain, low back pain and/or temporomandibular pain), in the Belgian adult population.&#xD;
  &#xD;
        Methods: Belgian adults from the general population will be recruited using non-probability&#xD;
        sampling (convenience and snowballing). The survey will be available online for a period of 6&#xD;
        months on LimeSurvey software. Multivariable logistic regression analyses will be performed&#xD;
        to determine the association between a combination of lifestyle factors (sleep, physical&#xD;
        activity, stress, weight, smoking, nutrition) and the presence of musculoskeletal pain.&#xD;
  &#xD;
        Discussion: The results of the study will provide data about associations between a&#xD;
        combination of lifestyle factors and the presence of musculoskeletal pain. This could&#xD;
        strengthen current evidence about the importance of adhering to a healthy lifestyle and&#xD;
        improve understanding of its association with musculoskeletal pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Numerous studies have evaluated the association between some lifestyle factors&#xD;
        (e.g., physical activity, sleep, stress) and the presence of musculoskeletal pain (neck pain,&#xD;
        low back pain or temporomandibular pain). However, the vast majority of them studied only one&#xD;
        lifestyle factor at a time, included specific populations (e.g., workers, nurses), or did not&#xD;
        use validated questionnaires. Very few studies to date have investigated the combination of&#xD;
        several lifestyle factors. Assessing a single factor does not represent reality, since&#xD;
        lifestyle factors are correlated with each other (adherence to some encourages adherence to&#xD;
        others, as does non-adherence).&#xD;
  &#xD;
        Objective: The aim of this online cross-sectional survey is to determine the association&#xD;
        between a combination of lifestyle factors and the presence of musculoskeletal pain (neck&#xD;
        pain, low back pain and/or temporomandibular pain), in the Belgian adult population.&#xD;
  &#xD;
        Methods: Belgian adults from the general population will be recruited using non-probability&#xD;
        sampling (convenience and snowballing). The survey will be available online for a period of 6&#xD;
        months on LimeSurvey software. The questionnaire will include questions about general data,&#xD;
        presence of musculoskeletal pain (neck pain, low back pain and temporomandibular pain), and&#xD;
        lifestyle factors (sleep, physical activity, stress, weight, smoking, nutrition).&#xD;
        Multivariable logistic regression analyses will be performed to determine the association&#xD;
        between the combination of lifestyle factors and the presence of musculoskeletal pain.&#xD;
        Musculoskeletal pains (neck, low back, temporomandibular) will be analyzed separately and&#xD;
        together (multisite pain). As sex seems to play a role in the presence of musculoskeletal&#xD;
        pain, different analyses will be performed according to sex (both sexes, males only, females&#xD;
        only). Potential confounding and modifying factors (e.g., age, anxiety, depression,...) will&#xD;
        be included in the multivariable logistic regression models. Results will be presented using&#xD;
        odds ratios (OR) and their 95% confidence intervals.&#xD;
  &#xD;
        Discussion: The results of the study will provide data about associations between a&#xD;
        combination of lifestyle factors and the presence of musculoskeletal pain. This could&#xD;
        strengthen current evidence about the importance of adhering to a healthy lifestyle and&#xD;
        improve understanding of its association with musculoskeletal pain. These findings could help&#xD;
        clinicians manage these musculoskeletal pains, by considering the role a lifestyle behavior&#xD;
        may have on them.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">March 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 20, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Neck pain (in the last 30 days)</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>The presence of neck pain in the last 30 days will be determined using closed questions on pain location, pain intensity, pain-related disability, pain etiology, and pain duration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Low back pain (in the last 30 days)</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>The presence of low back pain in the last 30 days will be determined using closed questions on pain location, pain intensity, pain-related disability, pain etiology, and pain duration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Temporomandibular pain (in the last 30 days)</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>The presence of temporomandibular pain in the last 30 days will be determined using the &quot;Temporo-Mandibular Disorders Pain Screener DC-TMD&quot; questionnaire (which consists of 3 questions designed to screen for the presence of temporomandibular pain in the last 30 days) and closed questions on pain-related disability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multisite pain (in the last 30 days)</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>The presence of multisite pain in the last 30 days will be determined by the presence of more than one musculoskeletal pain in the last 30 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tobacco consumption</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>Tobacco consumption will be assessed through closed questions about the past and current smoking use, but also about passive smoking. Participants will be separated into 5 groups : daily smokers, occasional smokers, ex-smokers, passive smokers, and non smokers. Only non smokers and non passive smokers will be considered &quot;healthy&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-report questionnaire that consists of 19 items related to sleep habits within the past month and 7 clinically relevant domains of sleep difficulties: subjective sleep quality; sleep latency; sleep duration; sleep efficiency; sleep disturbances; use of sleep medication; and daytime dysfunction. Its score ranges from 0 to 21, and a total score &gt; 5 is used to indicate poor sleepers. Participants with a score less than or equal to 5 will be considered &quot;healthy&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>Physical activity will be assessed using the European Health Interview Survey - Physical Activity Questionnaire (EHIS-PAQ). The EHIS-PAQ is a self-report questionnaire that aims to evaluate how far the population is physically active and assesses PA during work, transportation, leisure time, sports, health-enhancing, and muscle-strengthening activities over a typical week. Participants will be considered &quot;healthy&quot; if they perform leisure-time or sports physical activity at least 150 minutes at moderate intensity or 75 minutes at high intensity per week (or a combination of these intensities), and strength training of the major muscles groups at least 2 days per week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Consumption of fruits and vegetables</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>Daily consumption of fruits and vegetables will be assessed by asking participants the amount of servings of fruits and vegetables they eat daily. Participants will be considered &quot;healthy&quot; if they consume 5 or more servings of fruits and vegetables per day (e.g., at least 500g/day).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived stress</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>Perceived stress will be assessed using the &quot;Perceived Stress Scale - 10 items&quot; (PSS-10). PSS-10 assesses the imbalance between the individual's perception of the constraints of his environment and his perception of his own ability to cope with them. PSS-10 is a self-report questionnaire of 10 items, in which people are asked to rate on a 5-point scale the extent to which they experienced each of the listed feelings and thoughts, in the past month (from &quot;never&quot; to &quot;very often&quot;). Participants with a total PSS-10 score between 0 and 13 (&quot;low stress&quot;) will be considered &quot;healthy&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body mass index</measure>
      <time_frame>Baseline (at the time of completing the questionnaire)</time_frame>
      <description>Body Mass Index (BMI) will be assessed by asking participants about their height and weight. Height and weight will be combined to calculate the BMI : weight/height² (kg/m²). Participants with a BMI between 18.5 kg/m² and less than 25 kg/m² will be considered &quot;healthy&quot; (normal weight).</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Neck Pain</condition>
    <condition>Low Back Pain</condition>
    <condition>Temporomandibular Pain</condition>
    <arm_group>
      <arm_group_label>People without musculoskeletal pain</arm_group_label>
      <description>People who do not suffer from musculoskeletal pain (neck pain, low back pain and/or temporomandibular pain), with or without a healthy lifestyle behavior.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>People with musculoskeletal pain</arm_group_label>
      <description>People suffering from musculoskeletal pain (neck pain, low back pain and/or temporomandibular pain), with or without a healthy lifestyle behavior.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Any adult (&gt; 18 years old), male or female, living in Belgium, can complete the&#xD;
          questionnaire.&#xD;
  &#xD;
          The study population will include only adults, men and women, living in Belgium, who have&#xD;
          access to the Internet.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age over 18 years (adults), males or females, living in Belgium&#xD;
  &#xD;
            -  To understand French and/or Dutch&#xD;
  &#xD;
            -  To be able to provide informed consent&#xD;
  &#xD;
            -  To have access to the Internet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age under 18 years&#xD;
  &#xD;
            -  Inability to complete the questionnaire&#xD;
  &#xD;
            -  Inability to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laurent Pitance, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Université Catholique de Louvain</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexandre Luc, MSc</last_name>
      <phone>+32479959115</phone>
      <email>alexandre.luc@uclouvain.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>Université Catholique de Louvain</name>
        <address>
          <city>Bruxelles</city>
          <zip>1200</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Julie Vanacker, PhD</last_name>
        <phone>003227647980</phone>
        <email>julie.vanacker@saintluc.uclouvain.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lifestyle</keyword>
    <keyword>Cross-sectional</keyword>
    <keyword>Musculoskeletal pain</keyword>
    <keyword>Survey</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Pain</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
      <mesh_term>Neck Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06019403
  org study id: MUSKULO PAIN
  nct id: NCT06019403
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective: The aim of this online cross-sectional survey is to determine the association
        between a combination of lifestyle factors and the presence of musculoskeletal pain (neck
        pain, low back pain and/or temporomandibular pain), in the Belgian adult population.
  
        Methods: Belgian adults from the general population will be recruited using non-probability
        sampling (convenience and snowballing). The survey will be available online for a period of 6
        months on LimeSurvey software. Multivariable logistic regression analyses will be performed
        to determine the association between a combination of lifestyle factors (sleep, physical
        activity, stress, weight, smoking, nutrition) and the presence of musculoskeletal pain.
  
        Discussion: The results of the study will provide data about associations between a
        combination of lifestyle factors and the presence of musculoskeletal pain. This could
        strengthen current evidence about the importance of adhering to a healthy lifestyle and
        improve understanding of its association with musculoskeletal pain.
  Background: Numerous studies have evaluated the association between some lifestyle factors
        (e.g., physical activity, sleep, stress) and the presence of musculoskeletal pain (neck pain,
        low back pain or temporomandibular pain). However, the vast majority of them studied only one
        lifestyle factor at a time, included specific populations (e.g., workers, nurses), or did not
        use validated questionnaires. Very few studies to date have investigated the combination of
        several lifestyle factors. Assessing a single factor does not represent reality, since
        lifestyle factors are correlated with each other (adherence to some encourages adherence to
        others, as does non-adherence).
  
        Objective: The aim of this online cross-sectional survey is to determine the association
        between a combination of lifestyle factors and the presence of musculoskeletal pain (neck
        pain, low back pain and/or temporomandibular pain), in the Belgian adult population.
  
        Methods: Belgian adults from the general population will be recruited using non-probability
        sampling (convenience and snowballing). The survey will be available online for a period of 6
        months on LimeSurvey software. The questionnaire will include questions about general data,
        presence of musculoskeletal pain (neck pain, low back pain and temporomandibular pain), and
        lifestyle factors (sleep, physical activity, stress, weight, smoking, nutrition).
        Multivariable logistic regression analyses will be performed to determine the association
        between the combination of lifestyle factors and the presence of musculoskeletal pain.
        Musculoskeletal pains (neck, low back, temporomandibular) will be analyzed separately and
        together (multisite pain). As sex seems to play a role in the presence of musculoskeletal
        pain, different analyses will be performed according to sex (both sexes, males only, females
        only). Potential confounding and modifying factors (e.g., age, anxiety, depression,...) will
        be included in the multivariable logistic regression models. Results will be presented using
        odds ratios (OR) and their 95% confidence intervals.
  
        Discussion: The results of the study will provide data about associations between a
        combination of lifestyle factors and the presence of musculoskeletal pain. This could
        strengthen current evidence about the importance of adhering to a healthy lifestyle and
        improve understanding of its association with musculoskeletal pain. These findings could help
        clinicians manage these musculoskeletal pains, by considering the role a lifestyle behavior
        may have on them.
  observational model: Ecologic or Community
  time perspective: Cross-Sectional
  measure: Neck pain (in the last 30 days)
  time frame: Baseline (at the time of completing the questionnaire)
  description: The presence of neck pain in the last 30 days will be determined using closed questions on pain location, pain intensity, pain-related disability, pain etiology, and pain duration.
  measure: Low back pain (in the last 30 days)
  time frame: Baseline (at the time of completing the questionnaire)
  description: The presence of low back pain in the last 30 days will be determined using closed questions on pain location, pain intensity, pain-related disability, pain etiology, and pain duration.
  measure: Temporomandibular pain (in the last 30 days)
  time frame: Baseline (at the time of completing the questionnaire)
  description: The presence of temporomandibular pain in the last 30 days will be determined using the "Temporo-Mandibular Disorders Pain Screener DC-TMD" questionnaire (which consists of 3 questions designed to screen for the presence of temporomandibular pain in the last 30 days) and closed questions on pain-related disability.
  measure: Multisite pain (in the last 30 days)
  time frame: Baseline (at the time of completing the questionnaire)
  description: The presence of multisite pain in the last 30 days will be determined by the presence of more than one musculoskeletal pain in the last 30 days.
  measure: Tobacco consumption
  time frame: Baseline (at the time of completing the questionnaire)
  description: Tobacco consumption will be assessed through closed questions about the past and current smoking use, but also about passive smoking. Participants will be separated into 5 groups : daily smokers, occasional smokers, ex-smokers, passive smokers, and non smokers. Only non smokers and non passive smokers will be considered "healthy".
  measure: Sleep quality
  time frame: Baseline (at the time of completing the questionnaire)
  description: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-report questionnaire that consists of 19 items related to sleep habits within the past month and 7 clinically relevant domains of sleep difficulties: subjective sleep quality; sleep latency; sleep duration; sleep efficiency; sleep disturbances; use of sleep medication; and daytime dysfunction. Its score ranges from 0 to 21, and a total score > 5 is used to indicate poor sleepers. Participants with a score less than or equal to 5 will be considered "healthy".
  measure: Physical activity
  time frame: Baseline (at the time of completing the questionnaire)
  description: Physical activity will be assessed using the European Health Interview Survey - Physical Activity Questionnaire (EHIS-PAQ). The EHIS-PAQ is a self-report questionnaire that aims to evaluate how far the population is physically active and assesses PA during work, transportation, leisure time, sports, health-enhancing, and muscle-strengthening activities over a typical week. Participants will be considered "healthy" if they perform leisure-time or sports physical activity at least 150 minutes at moderate intensity or 75 minutes at high intensity per week (or a combination of these intensities), and strength training of the major muscles groups at least 2 days per week.
  measure: Consumption of fruits and vegetables
  time frame: Baseline (at the time of completing the questionnaire)
  description: Daily consumption of fruits and vegetables will be assessed by asking participants the amount of servings of fruits and vegetables they eat daily. Participants will be considered "healthy" if they consume 5 or more servings of fruits and vegetables per day (e.g., at least 500g/day).
  measure: Perceived stress
  time frame: Baseline (at the time of completing the questionnaire)
  description: Perceived stress will be assessed using the "Perceived Stress Scale - 10 items" (PSS-10). PSS-10 assesses the imbalance between the individual's perception of the constraints of his environment and his perception of his own ability to cope with them. PSS-10 is a self-report questionnaire of 10 items, in which people are asked to rate on a 5-point scale the extent to which they experienced each of the listed feelings and thoughts, in the past month (from "never" to "very often"). Participants with a total PSS-10 score between 0 and 13 ("low stress") will be considered "healthy".
  measure: Body mass index
  time frame: Baseline (at the time of completing the questionnaire)
  description: Body Mass Index (BMI) will be assessed by asking participants about their height and weight. Height and weight will be combined to calculate the BMI : weight/height² (kg/m²). Participants with a BMI between 18.5 kg/m² and less than 25 kg/m² will be considered "healthy" (normal weight).
  arm group label: People without musculoskeletal pain
  description: People who do not suffer from musculoskeletal pain (neck pain, low back pain and/or temporomandibular pain), with or without a healthy lifestyle behavior.
  arm group label: People with musculoskeletal pain
  description: People suffering from musculoskeletal pain (neck pain, low back pain and/or temporomandibular pain), with or without a healthy lifestyle behavior.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Laurent Pitance, PhD
  role: Principal Investigator
  affiliation: Université Catholique de Louvain
  last name: Alexandre Luc, MSc
  phone: +32479959115
  email: alexandre.luc@uclouvain.be
  facility: 
  contact: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Musculoskeletal Pain
  mesh term: Low Back Pain
  mesh term: Neck Pain
  sharing ipd: No