Neck PainNCT04201366
Risk Factors and Risk Profiles for Persistent Neck Pain in Young Adults: Results From the HUNT Study
An observational study of Neck Pain, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
Neck pain is one of the most prevalent musculoskeletal disorder in Norway among older adolescents and young adults. Despite this, little research exist on risk factors for neck pain in the transitional life phase from adolescence to young adulthood. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- How many people
- 8,562 participants
- Where
- 1 siteNorway
- 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 from North Trøndelag County in Norway aged 13-19 years.
Who may be able to join
- Adolescents between 13-19 years
Who cannot join
- Adolescents who reports neck/shoulder pain at baseline
- Adolescents who reports juvenile arthritis at baseline (sample 2)
Trial locations and contacts
1 site in 1 country.
About this study
Neck pain is one of the most prevalent musculoskeletal disorder in Norway among older adolescents and young adults. Despite this, little research exist on risk factors for neck pain in the transitional life phase from adolescence to young adulthood. In this prospective cohort study, already collected data from The Nord-Trøndelag Health study, Young HUNT 3 and HUNT 4 will be used to investigate possible risk factors and risk profiles developed in adolescence.
Read the detailed description
Little research exists about risk factors for neck pain in adolescents and young adults. Knowledge of risk factors associated with development of neck pain can inform practice and can further enable preventive initiatives with the aim of reducing this prevalent and costly disorder. By investigating risk profiles as well as single risk factors, it might be possible to identify behavioural patterns and profiles of adolescent most at risk of developing neck pain in young adulthood.
The objective of this study is to investigate potential risk factors and risk profiles for persistent neck pain in adolescence.
This is a prospective cohort study using data from The North Trøndelag Health study (HUNT). The HUNT study is a large population survey conducted in the North Trøndelag County in Norway, consisting of four surveys conducted with 11 years intervals. All inhabitants above 13 years old were invited to participate in either Young HUNT (13-19 years of age) or HUNT (20 years and above).
In this cohort study, data from Young HUNT 3 (2006-2008) and HUNT 4 (2017-2019) will be used to investigate participants from adolescence through young adulthood. The HUNT3 assessment was conducted during school hours, and the students had to answer a comprehensive questionnaire regarding biological, psychological and social factors. In addition, height and weight were measured. For participants not attending school, the questionnaire was sent to their home address, and participants were invited to do the physical measurements in a local field station.The same participants were followed up 11 years later (HUNT4). The participants were sent an invitation letter home and asked to fulfill a questionnaire.
Potential risk factors (from HUNT3):
Gender, body mass index, pain in other body regions, number of pain sites, sleeping problems, physical activity level, depression and anxiety, self esteem, resilience, loneliness and family economy.
Statistical analysis:
All statistical analyses will be conducted using IBM SPSS statistics for Windows version 25 and STATA statistical software system version 15. All statistical test will be two sided and the nominal p-value will be reported. 95% confidence intervals will be reported. Preliminary analyses of frequencies, missing data and normality will be conducted. The assumption of normal distribution will be investigated using histograms and QQ-plots.
Missing data:
Participants with missing data on the main outcome will be excluded from the analyses. Missing data on exposure variables will be handled by a model-based imputation (multiple imputation), unless the missing exceeds 20% and missing at random can be assumed. Exposure variables with more than 20% missing data will be excluded.
Multicollinearity:
Before conducting regression analyses, multicollinearity between the independent variables will be assessed. If independent variables correlates with a coefficient of stronger than 0.7, the risk factor that have the highest correlation with the outcome will be used in the multivariate analysis.
Logistic regression:
The potential risk factors listed above will individually be analysed in univariate models with persistent neck pain as the dependent variables. Variables with a p-value of ≤ 0.10 in univariate analysis will be included in multivariate analyses. Variables with a p-value of ≤ 0.05 will remain in the multivariate model, and the remaining variables no longer be statistically relevant will be removed from the final model. The results will be reported as odds ratios (OR) with corresponding 95% confidence intervals (95% CI).
Risk Matrices:
To identify risk profiles for persistent neck pain, risk matrices will be developed. The odds computed in the final regression model developed will be transformed into probabilities, and the results will be arranged in a risk matrix.
- Conditions
- Neck Pain
- Being tested
- No intervention
- Keywords
- neck pain, musculoskeletal pain, young adults, risk factors
- Medical subject headings
- Neck Pain, 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 |
|---|---|---|
| Sample 1 | All participants fulfilling the inclusion criteria. Receives: Other: No intervention | |
| Sample 2 | Participants fulfilling the inclusion criteria and reports no neck/shoulder pain at baseline. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent neck pain lasting 3 months or more the last year
Persistent neck pain lasting 3 months or more the last year was measured by the Standardised Nordic Questionaire for Musculoskeletal Symptoms. The questionnaire included question about pain or stiffness in the neck that has lasted at least 3 consecutive months the last year, with the responses yes or no.
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- 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 Neck 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201366
- Sponsor's protocol ID
- 2019/517
- Status last verified
- Mar 2020
- First submitted
- 11 Dec 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Risk Profiles for Persistent Neck Pain in Young Adults: Results From the HUNT Study
- ClinicalTrials.gov ID
- NCT04201366
- Acronym / sponsor ID
- 2019/517
- Conditions
- Neck Pain
- Keywords
- neck pain, musculoskeletal pain, young adults, risk factors
- 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
- 17 Dec 2019 (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.
Neck pain is one of the most prevalent musculoskeletal disorder in Norway among older adolescents and young adults. Despite this, little research exist on risk factors for neck pain in the transitional life phase from adolescence to young adulthood. In this prospective cohort study, already collected data from The Nord-Trøndelag Health study, Young HUNT 3 and HUNT 4 will be used to investigate possible risk factors and risk profiles developed in adolescence.
Detailed description
Little research exists about risk factors for neck pain in adolescents and young adults. Knowledge of risk factors associated with development of neck pain can inform practice and can further enable preventive initiatives with the aim of reducing this prevalent and costly disorder. By investigating risk profiles as well as single risk factors, it might be possible to identify behavioural patterns and profiles of adolescent most at risk of developing neck pain in young adulthood.
The objective of this study is to investigate potential risk factors and risk profiles for persistent neck pain in adolescence.
This is a prospective cohort study using data from The North Trøndelag Health study (HUNT). The HUNT study is a large population survey conducted in the North Trøndelag County in Norway, consisting of four surveys conducted with 11 years intervals. All inhabitants above 13 years old were invited to participate in either Young HUNT (13-19 years of age) or HUNT (20 years and above).
In this cohort study, data from Young HUNT 3 (2006-2008) and HUNT 4 (2017-2019) will be used to investigate participants from adolescence through young adulthood. The HUNT3 assessment was conducted during school hours, and the students had to answer a comprehensive questionnaire regarding biological, psychological and social factors. In addition, height and weight were measured. For participants not attending school, the questionnaire was sent to their home address, and participants were invited to do the physical measurements in a local field station.The same participants were followed up 11 years later (HUNT4). The participants were sent an invitation letter home and asked to fulfill a questionnaire.
Potential risk factors (from HUNT3):
Gender, body mass index, pain in other body regions, number of pain sites, sleeping problems, physical activity level, depression and anxiety, self esteem, resilience, loneliness and family economy.
Statistical analysis:
All statistical analyses will be conducted using IBM SPSS statistics for Windows version 25 and STATA statistical software system version 15. All statistical test will be two sided and the nominal p-value will be reported. 95% confidence intervals will be reported. Preliminary analyses of frequencies, missing data and normality will be conducted. The assumption of normal distribution will be investigated using histograms and QQ-plots.
Missing data:
Participants with missing data on the main outcome will be excluded from the analyses. Missing data on exposure variables will be handled by a model-based imputation (multiple imputation), unless the missing exceeds 20% and missing at random can be assumed. Exposure variables with more than 20% missing data will be excluded.
Multicollinearity:
Before conducting regression analyses, multicollinearity between the independent variables will be assessed. If independent variables correlates with a coefficient of stronger than 0.7, the risk factor that have the highest correlation with the outcome will be used in the multivariate analysis.
Logistic regression:
The potential risk factors listed above will individually be analysed in univariate models with persistent neck pain as the dependent variables. Variables with a p-value of ≤ 0.10 in univariate analysis will be included in multivariate analyses. Variables with a p-value of ≤ 0.05 will remain in the multivariate model, and the remaining variables no longer be statistically relevant will be removed from the final model. The results will be reported as odds ratios (OR) with corresponding 95% confidence intervals (95% CI).
Risk Matrices:
To identify risk profiles for persistent neck pain, risk matrices will be developed. The odds computed in the final regression model developed will be transformed into probabilities, and the results will be arranged in a risk matrix.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sample 1 | – | Other: No interventionAll participants fulfilling the inclusion criteria. |
| Sample 2 | – | Other: No interventionParticipants fulfilling the inclusion criteria and reports no neck/shoulder pain at baseline. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents from North Trøndelag County in Norway aged 13-19 years.
Key inclusion criteria (1 listed)
- Adolescents between 13-19 years
Key exclusion criteria (2 listed)
- Adolescents who reports neck/shoulder pain at baseline
- Adolescents who reports juvenile arthritis at baseline (sample 2)
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 | Sample 1, Sample 2 |
Primary outcome
Persistent neck pain lasting 3 months or more the last year
Time frame: 11 years
Persistent neck pain lasting 3 months or more the last year was measured by the Standardised Nordic Questionaire for Musculoskeletal Symptoms. The questionnaire included question about pain or stiffness in the neck that has lasted at least 3 consecutive months the last year, with the responses 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 11 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Oslo Metropolitan University at 1 site in Norway.
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 11 Mar 2020. 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 Norway. 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?
Persistent neck pain lasting 3 months or more the last year (time frame: 11 years). 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 11 Mar 2020.