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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06019403
Other study ID # MUSKULO PAIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2023
Est. completion date May 16, 2024

Study information

Verified date May 2024
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1188
Est. completion date May 16, 2024
Est. primary completion date May 16, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Université Catholique de Louvain Bruxelles

Sponsors (2)

Lead Sponsor Collaborator
Université Catholique de Louvain Fonds National de la Recherche Scientifique

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck pain (in the last 30 days) 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. Baseline (at the time of completing the questionnaire)
Primary Low back pain (in the last 30 days) 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. Baseline (at the time of completing the questionnaire)
Primary Temporomandibular pain (in the last 30 days) 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. Baseline (at the time of completing the questionnaire)
Primary Multisite pain (in the last 30 days) 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. Baseline (at the time of completing the questionnaire)
Primary Tobacco consumption 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". Baseline (at the time of completing the questionnaire)
Primary Sleep quality 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". Baseline (at the time of completing the questionnaire)
Primary Physical activity 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. Baseline (at the time of completing the questionnaire)
Primary Consumption of fruits and vegetables 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). Baseline (at the time of completing the questionnaire)
Primary Perceived stress 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". Baseline (at the time of completing the questionnaire)
Primary Body mass index 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). Baseline (at the time of completing the questionnaire)
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