NCT06019403

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,188

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 16, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

August 16, 2023

Last Update Submit

May 17, 2024

Conditions

Keywords

LifestyleCross-sectionalMusculoskeletal painSurvey

Outcome Measures

Primary Outcomes (10)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Age under 18 years
  • Inability to complete the questionnaire
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Neck PainLow Back PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Laurent Pitance, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 31, 2023

Study Start

November 16, 2023

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations