Musculoskeletal PainNCT04575974
Lifestyle in Adolescence and Persistent Musculoskeletal Pain in Young Adulthood
An observational study of Musculoskeletal Pain, run by Oslo Metropolitan University.
Trial summary
Experiencing an episode of musculoskeletal (MSK) pain in young age significantly increases the risk of developing MSK pain later in life. Consequently, knowledge on modifiable risk factors early in life is needed. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 8,562 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Feb 2019
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents (13-19 years) from Nord-Trøndelag in Norway.
Who may be able to join
- Respondents in Young-HUNT 3
Who cannot join
- Participants reporting juvenile arthritis
- Participants ≥ 20 years in Young-HUNT3
About this study
Official title: Combined Lifestyle Factors in Adolescence and Later Persistent Musculoskeletal Pain in Young Adulthood: Prospective Analyses From the HUNT Study
Experiencing an episode of musculoskeletal (MSK) pain in young age significantly increases the risk of developing MSK pain later in life. Consequently, knowledge on modifiable risk factors early in life is needed. In this prospective cohort study, data from the population-based Nord-Trøndelag Health Study (HUNT) will be used to investigate whether a combination of lifestyle factors in adolescence is associated with persistent MSK pain in young adulthood.
Read the detailed description
There is need for knowledge on modifiable risk factors for MSK pain in young ages to better target treatment and preventive. A combination of lifestyle factors has been associated with several health issues including MSK pain in adults, but has to the best of our knowledge not previously been investigated as a risk factor for MSK pain in the youth.
OBJECTIVE The objective of this study is to investigate whether a combination of lifestyle factors in adolescence is associated with later persistent MSK pain in young adulthood. Lifestyle factors will be assessed by combing levels of physical activity, sleep problems, fruit/vegetable consumption, alcohol consumption, use of drugs and smoking.
The analysis will be conducted in a sample of adolescents with MSK pain, and in a sample of adolescents without MSK pain in the first survey, separately.
STUDY DESIGN AND PLAN This study will be a prospective cohort study using data from the large population-based Nord Trøndelag Health Study (HUNT). Data from YoungHUNT3 (2006-2008) and HUNT4 (2017-2019) will be used, including the same participants examined With 11-year follow-up. The data in Young-HUNT 3 was collected through questionnaires, interviews and measurements during school time. Adolescents, who did not attend school, received an invitation to participate by mail. The outcome data was obtained by electronic questionnaire or paper from HUNT 4.
EXPOSURE VARIABLE A combined lifestyle variable will be composed based on scorings in the lifestyle variables physical activity level, sleep problems, fruit/vegetable consumption, alcohol consumption, drug use and smoking level from Young-HUNT3, which will all be categorized as healthy/ unhealthy (as defined below). The combined lifestyle variable will be arranged with 0/1 unhealthy lifestyle factors present as the reference category, and 2 factor, 3 factors and ≥4 unhealthy lifestyle factors present as the other categories. The combined variable will be investigated with different thresholds of alcohol consumption.
- Physical activity level: less than 2-3 days a week with sports or exercise is classified as a unhealthy level.
- Sleep problems is measured by two questions; one of whether the adolescents have problems falling asleep at night and one of whether the adolescents wake up early and have problems falling asleep again. Answering "often" or "almost every night" on one or both of these questions is classified as unhealthy.
- Fruit / vegetables consumption is measured by questions of consumption frequency. Answering "several times a day" on both questions will be considered a sufficient consumption.
- Alcohol consumption is measured by a question of whether the participants have ever tried to drink alcohol, and a question of whether the participants have ever been drinking so much that they have felt intoxicated (drunk). Those who have never tried drinking alcohol or have been intoxicated ≤10 times will be classified as healthy. Reporting >10 intoxications will be classified as unhealthy.
- Use of drugs: those who answer that they have tried hash, marijuana or other drugs will form the unhealthy group.
- Smoking will be dichotomized with no smokers in the healthy group and daily and occasional smokers in the unhealthy group. Previously smokers will be included in the no smoking group.
CONFOUNDING FACTORS
Background factors
- Sex
- Age
- Perceived family economic
Health factors
- Psychological distress, measured by the Symptom Checklist-5.
- Other chronic diseases, including asthma, diabetes, migraine and/or epilepsy
- Pain impact on daily activities at baseline (in the analyses of the sample with MSK pain at baseline only)
- Number of pain sites at baseline (in the analyses of the sample with MSK pain at baseline only) (Additional analyses will be conducted with adjustment for BMI, measured by kg/m2).
ANALYSIS METHODS Statistical tests will be two-sided, and p-values <0.05 will be considered statistically significant. P-value and the 95% confidence intervals will be reported. All continuous variables will be investigated for normality through histograms and QQ-plots. Normally distributed descriptive data of study participant will be presented with means and standard deviations (SD), skewed data will be presented with median and ranges and categorical data will be presented as counts and percentages. The analysis will be conducted with STATA statistical software system.
Missing data:
For missing data on the exposure variable and confounding factors, multiple imputation will be considered. Variables with more than 20% missing data will be excluded. Participants with missing outcome data will be excluded from the analyses. Characteristics of the individuals lost to follow-up will be compared to characteristics of responders at follow-up.
Incidence and prevalence:
The prevalence and incidence rate of MSK pain will be presented.
Logistic regression:
Logistic regression will be used to investigate the association between combined lifestyle factors in adolescence and persistent MSK pain in young adulthood. The combined lifestyle factor variable will be investigated with different thresholds of alcohol consumption. The associations will be investigated in unadjusted and adjusted analyses. The adjusted analyses will be conducted first with adjustment for background factors, second with adjustment for background factors and health factors. There will be conducted additional analyses with adjustment for BMI (kg/m2). The results will be reported as odds ratios (ORs) with 95% confidence intervals.
Sub-group analyses:
There will be conducted subgroup analyses for girls and boys separately, if there is a sufficient number of participants.
- Conditions
- Musculoskeletal Pain
- Being tested
- No intervention
- Keywords
- Musculoskeletal pain, Adolescence, young adulthood, Lifestyle, Risk factor
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Adolescents 13-19 years | All adolescents between 13-19 years of age in North Trøndelag county were invited to participate in HUNT 3 and followed up after 11 years. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent musculoskeletal pain lasting 3 months or more during the last year
The outcome was measured by the question: "In the last year, have you had pain or stiffness in muscles or joints that has lasted at least 3 consecutive months?" The responses were dichotomised into yes or no.
Measured: 1 year (measured 11 years after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study startSep 2006
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britt Elin Øiestad, Oslo Metropolitan University
- Investigators
- Britt Elin Øiestad, PhD, Principal investigator, Oslo Metroplitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575974
- Sponsor's protocol ID
- 2019/517B
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available from the HUNT database, but restrictions apply to the availability of these data, which were used under license for the current study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Lifestyle Factors in Adolescence and Later Persistent Musculoskeletal Pain in Young Adulthood: Prospective Analyses From the HUNT Study
- ClinicalTrials.gov ID
- NCT04575974
- Acronym / sponsor ID
- 2019/517B
- Conditions
- Musculoskeletal Pain
- Keywords
- Musculoskeletal pain, Adolescence, young adulthood, Lifestyle, Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,562 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 5 Oct 2020 (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.
Experiencing an episode of musculoskeletal (MSK) pain in young age significantly increases the risk of developing MSK pain later in life. Consequently, knowledge on modifiable risk factors early in life is needed. In this prospective cohort study, data from the population-based Nord-Trøndelag Health Study (HUNT) will be used to investigate whether a combination of lifestyle factors in adolescence is associated with persistent MSK pain in young adulthood.
Detailed description
There is need for knowledge on modifiable risk factors for MSK pain in young ages to better target treatment and preventive. A combination of lifestyle factors has been associated with several health issues including MSK pain in adults, but has to the best of our knowledge not previously been investigated as a risk factor for MSK pain in the youth.
OBJECTIVE The objective of this study is to investigate whether a combination of lifestyle factors in adolescence is associated with later persistent MSK pain in young adulthood. Lifestyle factors will be assessed by combing levels of physical activity, sleep problems, fruit/vegetable consumption, alcohol consumption, use of drugs and smoking.
The analysis will be conducted in a sample of adolescents with MSK pain, and in a sample of adolescents without MSK pain in the first survey, separately.
STUDY DESIGN AND PLAN This study will be a prospective cohort study using data from the large population-based Nord Trøndelag Health Study (HUNT). Data from YoungHUNT3 (2006-2008) and HUNT4 (2017-2019) will be used, including the same participants examined With 11-year follow-up. The data in Young-HUNT 3 was collected through questionnaires, interviews and measurements during school time. Adolescents, who did not attend school, received an invitation to participate by mail. The outcome data was obtained by electronic questionnaire or paper from HUNT 4.
EXPOSURE VARIABLE A combined lifestyle variable will be composed based on scorings in the lifestyle variables physical activity level, sleep problems, fruit/vegetable consumption, alcohol consumption, drug use and smoking level from Young-HUNT3, which will all be categorized as healthy/ unhealthy (as defined below). The combined lifestyle variable will be arranged with 0/1 unhealthy lifestyle factors present as the reference category, and 2 factor, 3 factors and ≥4 unhealthy lifestyle factors present as the other categories. The combined variable will be investigated with different thresholds of alcohol consumption.
- Physical activity level: less than 2-3 days a week with sports or exercise is classified as a unhealthy level.
- Sleep problems is measured by two questions; one of whether the adolescents have problems falling asleep at night and one of whether the adolescents wake up early and have problems falling asleep again. Answering "often" or "almost every night" on one or both of these questions is classified as unhealthy.
- Fruit / vegetables consumption is measured by questions of consumption frequency. Answering "several times a day" on both questions will be considered a sufficient consumption.
- Alcohol consumption is measured by a question of whether the participants have ever tried to drink alcohol, and a question of whether the participants have ever been drinking so much that they have felt intoxicated (drunk). Those who have never tried drinking alcohol or have been intoxicated ≤10 times will be classified as healthy. Reporting >10 intoxications will be classified as unhealthy.
- Use of drugs: those who answer that they have tried hash, marijuana or other drugs will form the unhealthy group.
- Smoking will be dichotomized with no smokers in the healthy group and daily and occasional smokers in the unhealthy group. Previously smokers will be included in the no smoking group.
CONFOUNDING FACTORS
Background factors
- Sex
- Age
- Perceived family economic
Health factors
- Psychological distress, measured by the Symptom Checklist-5.
- Other chronic diseases, including asthma, diabetes, migraine and/or epilepsy
- Pain impact on daily activities at baseline (in the analyses of the sample with MSK pain at baseline only)
- Number of pain sites at baseline (in the analyses of the sample with MSK pain at baseline only) (Additional analyses will be conducted with adjustment for BMI, measured by kg/m2).
ANALYSIS METHODS Statistical tests will be two-sided, and p-values <0.05 will be considered statistically significant. P-value and the 95% confidence intervals will be reported. All continuous variables will be investigated for normality through histograms and QQ-plots. Normally distributed descriptive data of study participant will be presented with means and standard deviations (SD), skewed data will be presented with median and ranges and categorical data will be presented as counts and percentages. The analysis will be conducted with STATA statistical software system.
Missing data:
For missing data on the exposure variable and confounding factors, multiple imputation will be considered. Variables with more than 20% missing data will be excluded. Participants with missing outcome data will be excluded from the analyses. Characteristics of the individuals lost to follow-up will be compared to characteristics of responders at follow-up.
Incidence and prevalence:
The prevalence and incidence rate of MSK pain will be presented.
Logistic regression:
Logistic regression will be used to investigate the association between combined lifestyle factors in adolescence and persistent MSK pain in young adulthood. The combined lifestyle factor variable will be investigated with different thresholds of alcohol consumption. The associations will be investigated in unadjusted and adjusted analyses. The adjusted analyses will be conducted first with adjustment for background factors, second with adjustment for background factors and health factors. There will be conducted additional analyses with adjustment for BMI (kg/m2). The results will be reported as odds ratios (ORs) with 95% confidence intervals.
Sub-group analyses:
There will be conducted subgroup analyses for girls and boys separately, if there is a sufficient number of participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents 13-19 years | – | Other: No interventionAll adolescents between 13-19 years of age in North Trøndelag county were invited to participate in HUNT 3 and followed up after 11 years. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents (13-19 years) from Nord-Trøndelag in Norway.
Key inclusion criteria (1 listed)
- Respondents in Young-HUNT 3
Key exclusion criteria (2 listed)
- Participants reporting juvenile arthritis
- Participants ≥ 20 years in Young-HUNT3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Adolescents 13-19 years |
Primary outcome
Persistent musculoskeletal pain lasting 3 months or more during the last year
Time frame: 1 year (measured 11 years after baseline)
The outcome was measured by the question: "In the last year, have you had pain or stiffness in muscles or joints that has lasted at least 3 consecutive months?" The responses were dichotomised into yes or no.
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 10 Sep 2021.
- Individual participant dataSharing planned: No. Data are available from the HUNT database, but restrictions apply to the availability of these data, which were used under license for the current study.
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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.
Britt Elin Øiestad, PhD principal investigator
Oslo Metroplitan University
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by Oslo Metropolitan University.
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 1 inclusion and 2 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Persistent musculoskeletal pain lasting 3 months or more during the last year (time frame: 1 year (measured 11 years after baseline)). 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 10 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.