- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06019403
Association Between a Healthy Lifestyle Behavior and Musculoskeletal Pain
Association Between a Healthy Lifestyle Behavior and Musculoskeletal Pain: an Online Cross-sectional Survey
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexandre Luc, MSc
- Phone Number: +32479959115
- Email: alexandre.luc@uclouvain.be
Study Locations
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Bruxelles, Belgium, 1200
- Recruiting
- Université Catholique de Louvain
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Contact:
- Julie Vanacker, PhD
- Phone Number: 003227647980
- Email: julie.vanacker@saintluc.uclouvain.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Any adult (> 18 years old), male or female, living in Belgium, can complete the questionnaire.
The study population will include only adults, men and women, living in Belgium, who have access to the Internet.
Description
Inclusion Criteria:
- Age over 18 years (adults), males or females, living in Belgium
- To understand French and/or Dutch
- To be able to provide informed consent
- To have access to the Internet
Exclusion Criteria:
- Age under 18 years
- Inability to complete the questionnaire
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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People without musculoskeletal pain
People who do not suffer from musculoskeletal pain (neck pain, low back pain and/or temporomandibular pain), with or without a healthy lifestyle behavior.
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People with musculoskeletal pain
People suffering from musculoskeletal pain (neck pain, low back pain and/or temporomandibular pain), with or without a healthy lifestyle behavior.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Neck pain (in the last 30 days)
Time Frame: Baseline (at the time of completing the questionnaire)
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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.
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Baseline (at the time of completing the questionnaire)
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Low back pain (in the last 30 days)
Time Frame: Baseline (at the time of completing the questionnaire)
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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.
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Baseline (at the time of completing the questionnaire)
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Temporomandibular pain (in the last 30 days)
Time Frame: Baseline (at the time of completing the questionnaire)
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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.
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Baseline (at the time of completing the questionnaire)
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Multisite pain (in the last 30 days)
Time Frame: Baseline (at the time of completing the questionnaire)
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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.
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Baseline (at the time of completing the questionnaire)
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Tobacco consumption
Time Frame: Baseline (at the time of completing the questionnaire)
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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".
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Baseline (at the time of completing the questionnaire)
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Sleep quality
Time Frame: Baseline (at the time of completing the questionnaire)
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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".
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Baseline (at the time of completing the questionnaire)
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Physical activity
Time Frame: Baseline (at the time of completing the questionnaire)
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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.
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Baseline (at the time of completing the questionnaire)
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Consumption of fruits and vegetables
Time Frame: Baseline (at the time of completing the questionnaire)
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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).
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Baseline (at the time of completing the questionnaire)
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Perceived stress
Time Frame: Baseline (at the time of completing the questionnaire)
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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".
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Baseline (at the time of completing the questionnaire)
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Body mass index
Time Frame: Baseline (at the time of completing the questionnaire)
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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).
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Baseline (at the time of completing the questionnaire)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurent Pitance, PhD, Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUSKULO PAIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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