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Musculoskeletal PainNCT04575974

Lifestyle in Adolescence and Persistent Musculoskeletal Pain in Young Adulthood

An observational study of Musculoskeletal Pain, run by Oslo Metropolitan University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT04575974
Study groupRoleWhat they receive
Adolescents 13-19 yearsAll 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.

  1. 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.

  1. First posted5 Oct 2020
  2. Study startSep 2006
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Resources

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)
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.

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.

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