Neck PainNCT06019403
Association Between a Healthy Lifestyle Behavior and Musculoskeletal Pain
An observational study of Neck Pain and Low Back Pain, run by Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Low Back Pain, Temporomandibular Pain
- How many people
- 1,188 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Nov 2023to 16 May 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age under 18 years
- Inability to complete the questionnaire
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain, Low Back Pain, Temporomandibular Pain
- Keywords
- Lifestyle, Cross-sectional, Musculoskeletal pain, Survey
- Medical subject headings
- Neck Pain, Low Back Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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).
Measured: 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".
Measured: 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).
Measured: Baseline (at the time of completing the questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start16 Nov 2023
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
- Investigators
- Laurent Pitance, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019403
- Sponsor's protocol ID
- MUSKULO PAIN
- Status last verified
- May 2024
- First submitted
- 16 Aug 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between a Healthy Lifestyle Behavior and Musculoskeletal Pain: an Online Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT06019403
- Acronym / sponsor ID
- MUSKULO PAIN
- Conditions
- Neck Pain, Low Back Pain, Temporomandibular Pain
- Keywords
- Lifestyle, Cross-sectional, Musculoskeletal pain, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,188 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 31 Aug 2023 (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.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18 years
- Inability to complete the questionnaire
- Inability to provide informed consent
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
Neck pain (in the last 30 days)
Time frame: Baseline (at the time of completing the questionnaire)
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.
Low back pain (in the last 30 days)
Time frame: Baseline (at the time of completing the questionnaire)
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.
Temporomandibular pain (in the last 30 days)
Time frame: Baseline (at the time of completing the questionnaire)
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.
Multisite pain (in the last 30 days)
Time frame: Baseline (at the time of completing the questionnaire)
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.
Tobacco consumption
Time frame: Baseline (at the time of completing the questionnaire)
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".
Sleep quality
Time frame: Baseline (at the time of completing the questionnaire)
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".
Physical activity
Time frame: Baseline (at the time of completing the questionnaire)
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.
Consumption of fruits and vegetables
Time frame: Baseline (at the time of completing the questionnaire)
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).
Perceived stress
Time frame: Baseline (at the time of completing the questionnaire)
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".
Body mass index
Time frame: Baseline (at the time of completing the questionnaire)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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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.
Laurent Pitance, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Low Back Pain, run by Université Catholique de Louvain at 1 site in Belgium.
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 4 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: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neck pain (in the last 30 days) (time frame: Baseline (at the time of completing the questionnaire)). The study lists 10 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 17 May 2024.