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.
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.
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:
- 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?
- 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.
- Conditions
- Musculoskeletal Pain
- 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.
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)
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.
- First posted26 Aug 2020
- Study start1 Sep 2010
- Primary completion1 Jun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 961 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04526522
- Acronym / sponsor ID
- 2019/599
- Conditions
- Musculoskeletal Pain
- Keywords
- musculoskeletal pain, adolescent, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 961 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Aug 2020 (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.
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.
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:
- 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?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Norwegian adolescents of 15-18 years of age.
Key inclusion criteria (1 listed)
- Adolescents between 15 and 16 years who live in Tromsø or Balsfjord Municipality
Key exclusion criteria (1 listed)
- Persistent MSK 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
Weekly musculoskeletal pain lasting for at least 3 months or more
Time frame: 2 years
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.
1 secondary outcome
Severe weekly MSK pain lasting for at least 3 months or more
Time frame: 2 years
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 10 Jun 2021.
- Derived from this study: PubMed 35027018Jahre 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.
- 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 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.