- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05036746
Health Complaints in Adolescence and Future Persistent Musculoskeletal Pain
Do Health Complaints in Adolescence Increase the Risk of Future Persistent Musculoskeletal Pain? Analyses From the Population-based Fit Futures Study
Study Overview
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adolescents, 15-19 years old, participating in Fit Futures 1
Exclusion Criteria:
- Age > 19 years at baseline
- Adolescents reporting persistent musculoskeletal pain at baseline
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/599B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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