Musculoskeletal PainNCT05036746
Health Complaints in Adolescence and Future Persistent Musculoskeletal Pain
An observational study of Musculoskeletal Pain, run by Oslo Metropolitan University.
Trial summary
Persistent musculoskeletal (MSK) pain in adolescence is associated with disability, absence from school and reduced quality of life. We know little about risk factors and underlying mechanisms of persistent MSK pain in this age group. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 1,038 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2010to 1 Jun 2013
- 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Norwegian adolescents, 15-19 years old
Who may be able to join
- Adolescents, 15-19 years old, participating in Fit Futures 1
Who cannot join
- Age > 19 years at baseline
- Adolescents reporting persistent musculoskeletal pain at baseline
About this study
Official title: Do Health Complaints in Adolescence Increase the Risk of Future Persistent Musculoskeletal Pain? Analyses From the Population-based Fit Futures Study
Persistent musculoskeletal (MSK) pain in adolescence is associated with disability, absence from school and reduced quality of life. We know little about risk factors and underlying mechanisms of persistent MSK pain in this age group. For example, the effect of other health complaints on the development of persistent MSK pain is scarcely investigated. In this prospective cohort study, data from the Fit Futures study on Norwegian adolescents (15-19 years old) will be used to investigate whether health complaints and an accumulation of health complaints in adolescence are associated with the incidence of persistent MSK pain two years later.
Read the detailed description
There is a need of knowledge on risk factors and underlying mechanisms of persistent MSK pain in adolescence to increase our understanding and facilitate preventative strategies.
OBJECTIVE:
The aims of this prospective cohort study are to investigate whether health complaints and an accumulation of health complaints in adolescence, are associated with the incidence of persistent MSK pain two years later.
METHODS:
This will be a prospective study using data from the Fit Futures study conducted in the northern Norway. Adolescents (15-19 years) were recruited to the first survey (Fit Futures 1, FF1) in 2010/2011, and followed up to years later (Fit Futures 2, FF2). Data was collected through a comprehensive questionnaire and physical tests.
The exposures will be common health complaints in adolescence measured in FF1, including self-reported asthma, allergic rhinitis, atopic eczema, abdominal pain, headache and psychological distress (Hopkins Symptom Checklist).
Potential confounders will include age, sex and parents' socioeconomic status.
Statistical analyses:
Histograms and QQ-plots will be used to investigate the distribution of data. Normally distributed data will be presented with means and standard deviations (SD), while median and range will be used to present skewed data. Categorical data will be presented as counts and percentages. Missing data in exposures and confounders will be considered handled with multiple imputation. Participants with missing data on outcome will be excluded from the analyses. Baseline characteristics of adolescents lost to follow-up or with incomplete outcome data in FF2 will be compared to baseline characteristics of respondents.
A two-year incidence rate of persistent MSK pain will be presented.
Logistic regression analyses, providing odds ratios (ORs) with 95% confidence intervals (CI), will be used to investigate the association between health complaints (measured in FF1) and later persistent MSK pain (measured in FF2). The association between health complaints and persistent MSK pain will first be investigated separately for each complaint (asthma, allergic rhinitis, atopic eczema, psychological distress, headache and abdominal pain), secondly as the number of health complaints regardless of type (using an ordinal count variable). All logistic regression analyses will be conducted as crude and adjusted analyses. Statistical analyses will be conducted with STATA statistical software system.
- Conditions
- Musculoskeletal Pain
- Being tested
- No intervention
- Keywords
- Musculoskeletal pain, Health complaints, Risk
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent musculoskeletal pain
Persistent musculoskeletal pain was measured at the 2-year follow-up by the questions: "Do you have persistent or constantly recurring pain that has lasted for three months or more?", "if you have persistent and constantly recurring pain that has lasted for 3 months or more, how often do you have this pain?" and "if you have persistent or constantly recurring pain that has lasted for 3 months or more, where does it hurt?". Persistent musculoskeletal pain will in this study be defined as pain that persist or constantly recur on a weekly basis or more often, for minimum three months, in one or more of the following pain sites; neck, jaw/temporormandibular joint, upper back, lower back, chest, shoulder, arm/elbow, hand, hip, thigh/knee/shin, ankle/foot.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Sep 2010
- Primary completion1 Jun 2013
- Study completion1 Jun 2013
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
- 1,038 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
- NCT05036746
- Sponsor's protocol ID
- 2019/599B
- Status last verified
- Oct 2021
- First submitted
- 2 Sep 2021
- Last updated
- 18 Oct 2021
- 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 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Health Complaints in Adolescence Increase the Risk of Future Persistent Musculoskeletal Pain? Analyses From the Population-based Fit Futures Study
- ClinicalTrials.gov ID
- NCT05036746
- Acronym / sponsor ID
- 2019/599B
- Conditions
- Musculoskeletal Pain
- Keywords
- Musculoskeletal pain, Health complaints, Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Jun 2013 (actual)
- First posted
- 8 Sep 2021 (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.
Persistent musculoskeletal (MSK) pain in adolescence is associated with disability, absence from school and reduced quality of life. We know little about risk factors and underlying mechanisms of persistent MSK pain in this age group. For example, the effect of other health complaints on the development of persistent MSK pain is scarcely investigated. In this prospective cohort study, data from the Fit Futures study on Norwegian adolescents (15-19 years old) will be used to investigate whether health complaints and an accumulation of health complaints in adolescence are associated with the incidence of persistent MSK pain two years later.
Detailed description
There is a need of knowledge on risk factors and underlying mechanisms of persistent MSK pain in adolescence to increase our understanding and facilitate preventative strategies.
OBJECTIVE:
The aims of this prospective cohort study are to investigate whether health complaints and an accumulation of health complaints in adolescence, are associated with the incidence of persistent MSK pain two years later.
METHODS:
This will be a prospective study using data from the Fit Futures study conducted in the northern Norway. Adolescents (15-19 years) were recruited to the first survey (Fit Futures 1, FF1) in 2010/2011, and followed up to years later (Fit Futures 2, FF2). Data was collected through a comprehensive questionnaire and physical tests.
The exposures will be common health complaints in adolescence measured in FF1, including self-reported asthma, allergic rhinitis, atopic eczema, abdominal pain, headache and psychological distress (Hopkins Symptom Checklist).
Potential confounders will include age, sex and parents' socioeconomic status.
Statistical analyses:
Histograms and QQ-plots will be used to investigate the distribution of data. Normally distributed data will be presented with means and standard deviations (SD), while median and range will be used to present skewed data. Categorical data will be presented as counts and percentages. Missing data in exposures and confounders will be considered handled with multiple imputation. Participants with missing data on outcome will be excluded from the analyses. Baseline characteristics of adolescents lost to follow-up or with incomplete outcome data in FF2 will be compared to baseline characteristics of respondents.
A two-year incidence rate of persistent MSK pain will be presented.
Logistic regression analyses, providing odds ratios (ORs) with 95% confidence intervals (CI), will be used to investigate the association between health complaints (measured in FF1) and later persistent MSK pain (measured in FF2). The association between health complaints and persistent MSK pain will first be investigated separately for each complaint (asthma, allergic rhinitis, atopic eczema, psychological distress, headache and abdominal pain), secondly as the number of health complaints regardless of type (using an ordinal count variable). All logistic regression analyses will be conducted as crude and adjusted analyses. Statistical analyses will be conducted with STATA statistical software system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Norwegian adolescents, 15-19 years old
Key inclusion criteria (1 listed)
- Adolescents, 15-19 years old, participating in Fit Futures 1
Key exclusion criteria (2 listed)
- Age > 19 years at baseline
- Adolescents reporting persistent musculoskeletal pain at baseline
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 | – |
Primary outcome
Persistent musculoskeletal pain
Time frame: Two years
Persistent musculoskeletal pain was measured at the 2-year follow-up by the questions: "Do you have persistent or constantly recurring pain that has lasted for three months or more?", "if you have persistent and constantly recurring pain that has lasted for 3 months or more, how often do you have this pain?" and "if you have persistent or constantly recurring pain that has lasted for 3 months or more, where does it hurt?". Persistent musculoskeletal pain will in this study be defined as pain that persist or constantly recur on a weekly basis or more often, for minimum three months, in one or more of the following pain sites; neck, jaw/temporormandibular joint, upper back, lower back, chest, shoulder, arm/elbow, hand, hip, thigh/knee/shin, ankle/foot.
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 18 Oct 2021.
- 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.
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 18 Oct 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 (time frame: Two 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 18 Oct 2021.