Health Complaints in Adolescence and Future Persistent Musculoskeletal Pain

October 8, 2021 updated by: Britt Elin Øiestad, Oslo Metropolitan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Norwegian adolescents, 15-19 years old

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo Metropolitan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019/599B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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