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Musculoskeletal PainNCT04526522

"Social Acceptance Among Peers and Musculoskeletal Pain in Adolescents"

An observational study of Musculoskeletal Pain, run by Oslo Metropolitan University at 1 site in Norway.

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

Musculoskeletal pain is common and often occurs already in adolescence. To be able to target future interventions that aim to prevent new episodes of MSK pain, more studies on modifiable risk factors are necessary. In this prospective cohort study, already collected data from the Fit Futures study will be used. Read more about this study

Who is it for?
Ages 15 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Pain
How many people
961 participants
Where
1 siteNorway
Study dates
1 Sep 2010to Sep 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 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Norwegian adolescents of 15-18 years of age.

Who may be able to join

  • Adolescents between 15 and 16 years who live in Tromsø or Balsfjord Municipality

Who cannot join

  • Persistent MSK pain at baseline

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Oslo Metropolitan University

    Oslo

Other trials in Norway

About this study

Official title: Does Low Social Acceptance Among Peers Increase the Risk of Future Persistent Musculoskeletal Pain in Adolescents? Prospective Data From the Fit Futures Study

Musculoskeletal pain is common and often occurs already in adolescence. To be able to target future interventions that aim to prevent new episodes of MSK pain, more studies on modifiable risk factors are necessary. In this prospective cohort study, already collected data from the Fit Futures study will be used. The aim is to investigate if perceived social acceptance among peers in the first year of high school is associated with musculoskeletal pain in the last year of high school, and if this association is moderated by psychological distress.

Read the detailed description

Few studies have investigated social factors in association with musculoskeletal pain in adolescents, such as perceived peer acceptance. Adolescence is a vulnerable period of life when peer relations is important in order to develop social, emotional and behavioural skills. Social relations have been linked to several health outcomes in previous studies. Therefore, this study aims to investigate if social acceptance among peers is associated with musculoskeletal pain in adolescents.

The research questions are:

  1. Is there a significant association between perceived social acceptance among peers during the first year of high school and persistent MSK pain two years later in adolescents?
  2. Is psychological distress an effect modifier of the relationship between perceived social acceptance among peers during the first year of high school and MSK pain two years later in adolescents?

Method:

This is a prospective cohort study using data from the Fit Futures (FF) study. Students from the first year of high school were included at baseline in Fit Futures 1 (FF1) and followed up for two years later in Fit Futures 2 (FF2). The students answered a comprehensive questionnaire, including biological, psychological, and social variables. They also underwent measurements of height and weight during school hours.

Baseline characteristics will be extracted from FF1 with data collected in the period 2010-2011. Baseline characteristics from adolescents who participated in the study and adolescents who were lost to follow-up will be presented and compared. Information about age, sex, parents socioeconomic status (SES), and body mass index (BMI), will be used to describe the study sample and as potential confounders.

Social acceptance among peers was measured by five questions from the revised Norwegian version of Self-perception Profile for Adolescent; scale for social competence and psychological distress was measured by the Hopkins Symptoms Checklist-10.

Statistical analyses:

All statistical tests will be two-sided, and the nominal p-values will be reported. All confidence intervals (CIs) will be reported as 95%. Preliminary analyses of frequencies, missing data and normality will be conducted. The assumption of normal distribution will be investigated using histograms and QQ-plots. Normally distributed data will be described with means and standard deviations (SDs), skewed data will be presented with medians and ranges. Categorical data will be reported as counts and percentages. All statistical analyses will be conducted using SPSS statistical software (SPSS Inc, Chicago, IL, USA).

Participants with missing data on the outcome will be excluded from the analyses. Missing data on the exposure variable will be handled by multiple imputations unless the missingness is very low (<10%). A two-year incidence rate of participants who reports no MSK pain at baseline and develops persistent MSK pain during the follow-up period will be calculated, presented as percentage with 95% CI.

Logistic regression:

Main analyses will be conducted in a sample of adolescents that report no persistent MSK pain at baseline. Secondary analyses will be conducted in the total sample regardless of pain status at baseline. Binary logistic regression will be conducted with social acceptance among peers as the exposure and persistent MSK pain as the outcome. Sex and chronic diseases will be included as confounders.

Moderation analyses:

The moderation analysis will be performed as described by Hayes, using PROCESS macro model 1 in SPSS. In the analysis, social acceptance will be included as the exposure, MSK pain as the outcome, and psychological distress as the possible effect modifier. Sex and chronic diseases will be included as confounders. Regression coefficients and ORs will be presented in figures and tables. Confidence intervals for the effect modifier will be constructed using a bias-corrected bootstrap method with 5000 bootstrap samples.

Additional analyses:

Drop-out analyses will be conducted to explore possible attrition bias by comparing baseline characteristics between participants lost to follow-up and responders at follow-up. The chi-square test will be used for comparison of categorical variables, independent samples t-test to compare normally distributed continuous variables, and Mann-Whitney U test to compare data with skewed distribution.

Being tested
No intervention
Keywords
musculoskeletal pain, adolescent, 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weekly musculoskeletal pain lasting for at least 3 months or more

    Persistent or recurrent musculoskeletal pain lasting for at least 3 months or more. The questionnaire included question about pain duration in 14 body regions. Shoulder, arm/elbow, hand, hips, thigh/knee/shin, ankle, neck, upper back, lower back were used to define MSK pain based on the body regions from the Nordic Musculoskeletal Pain Questionnaire. The responses were yes or no, and duration ranged from everyday to rarer than every week.

    Measured: 2 years

Secondary outcomes (1)
  1. Severe weekly MSK pain lasting for at least 3 months or more

    Persistent or recurrent MSK pain lasting for at least 3 months or more with a severity of at least 5 on a scale from 0-10 (0= no pain, 10=Worst pain imaginable). The questionnaire included question about pain duration in 14 body regions. Shoulder, arm/elbow, hand, hips, thigh/knee/shin, ankle, neck, upper back, lower back were used to define MSK pain based on the body regions from the Nordic Musculoskeletal Pain Questionnaire. The responses were yes or no, and duration ranged from everyday to rarer than every week.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2020
  2. Study start1 Sep 2010
  3. Primary completion1 Jun 2013
  4. Study completionSep 2013

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
961 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04526522
Sponsor's protocol ID
2019/599
Status last verified
Jun 2021
First submitted
19 Dec 2019
Last updated
10 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jahre H, Grotle M, Smedbraten K, Richardsen KR, Cote P, Steingrimsdottir OA, Nielsen C, Storheim K, Smastuen M, Stensland SO, Oiestad BE. Low social acceptance among peers increases the risk of persistent musculoskeletal pain in adolescents. Prospective data from the Fit Futures Study. BMC Musculoskelet Disord. 2022 Jan 13;23(1):44. doi: 10.1186/s12891-022-04995-6.

    PubMed 35027018

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal 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 1 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 Jun 2021. 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?

Weekly musculoskeletal pain lasting for at least 3 months or more (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04526522, which also lists 1 linked publication.

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 Jun 2021.

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