Musculoskeletal PainNCT06157112
Students' Lifestyle Behaviour and Later Health Care Utilization Due to Musculoskeletal Pain
An observational study of Musculoskeletal Pain, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
This study aims to assess whether there is an association between students' lifestyle behaviour, in terms of physical activity level, sleep duration, smoking status, alcohol consumption and use of cannabis and other illegal drugs, and later health care utilisation due to musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Lifestyle behaviour (exposure in a observational study)
- How many people
- 50,054 participants
- Where
- 1 siteNorway
- Study dates
- 6 Feb 2018to 5 Apr 2021
- How long will I take part?
- 3 Years
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University full-time students, 18-35 years of age
Who may be able to join
- All full-time Norwegian University students aged 18 to 35 years of age
Who cannot join
- students studying abroad
- students above 35 years of age
- students with health care utilisation due to musculoskeletal pain the last 12 months before baseline
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess whether there is an association between students' lifestyle behaviour, in terms of physical activity level, sleep duration, smoking status, alcohol consumption and use of cannabis and other illegal drugs, and later health care utilisation due to musculoskeletal pain. The study will combine data from a national survey in Norway (SHOT2018), in which all full-time university students in Norway were invited, with data from a register on health care utilisation in primary health care.
Read the detailed description
This study aims to determine:
- whether male and female university students' lifestyle behaviours, in terms of physical activity level, sleep durance, alcohol consumption, smoking and illicit drug use, are associated with future health care utilisation for musculoskeletal pain, back pain or neck pain, and ii) whether the number of adverse lifestyle behaviours is associated with future health care utilisation for musculoskeletal pain, back pain or neck pain.
Study design and setting:
Cohort study, in which data from the Students' Health and Wellbeing study (SHoT) is merged with data from the Norwegian Register of Primary Health Care (NRPHC).
The eligibility criteria:
Inclusion criteria • Participants of the SHoT2018 study (18-35 years of age)
Exclusion criteria
- Participants studying abroad
- Participants above 35 years of age
- Recent health care utilisation for a musculoskeletal pain diagnosis (the last 12 months prior to the exposure assessment)
Primary outcome:
- Health care utilisation for musculoskeletal pain in primary health care, registered in the NRPHC (follow-up period: 3 years after baseline)
Secondary outcome:
- Health care utilisation for back pain, registered in NRPHC (follow-up period: 3 years after baseline)
- Health care utilisation for neck pain, registered in NRPHC (follow-up period: 3 years after baseline)
Exposures:
- Physical activity, obtained from the SHOT-questionnaire, categorised in accordance with recommendations for weekly physical activity
- Sleep duration, obtained from the SHOT-questionnaire, categorised in accordance with recommendations
- Smoking (yes / no)
- Alcohol consumption (assessed with AUDIT)
- Illegal drug use (categorised in use the last year yes/no)
- Number of adverse lifestyle behaviours (0-5) (low physical activity, short sleep duration, smoking, risky alcohol use, illegal drug use the last year)
Potential confounders:
The following variables will be considered as potential confounders in the analyses: age, financial difficulties, physical health complaints, symptoms of depression and anxiety, BMI, other lifestyle behaviours, consultation frequency irrespective of cause, the last year prior baseline (the last will be used as an indicator of health care seeking behaviour)
Statistical analyses:
3-year incidence rates of health utilisation for musculoskeletal pain, back pain and neck pain will be computed
Crude and adjusted associations between each of the lifestyle behaviours and health care utilisation for musculoskeletal pain, back pain and neck pain will be assessed separately. Also, the association between the number of adverse lifestyle behaviours and musculoskeletal pain, back and neck pain will be assessed in crude and adjusted analyses. Modified Poisson regression will be used to analyse the associations with binary outcomes (health care utilisation for musculoskeletal pain yes/no). To asses the associations with an outcome variable reflecting the number of health care visits for musculoskeletal pain, the exact statistical analysis method will be chosen after inspection of the distribution of the outcome data. All analyses will be conducted stratified by sex.
The following sensitivity analyses will be considered:
- analyses stratified by baseline musculoskeletal pain status
- only including outcome data before 12 March 2020 to assess the associations prior to the Covid 19 restrictions
- excluding participants above 30 years of age to assess the associations in a sample of students withing the \"emerging adult\" definition (up to 30 years of age)
All analyses will be conducted with STATA statistical software system, version 16 (StataCorp., 2019)
- Conditions
- Musculoskeletal Pain
- Being tested
- Lifestyle behaviour (exposure in a observational study)
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle behaviour (exposure in a observational study)Other
Lifestyle behaviour, including physical activity, sleep duration, alcohol consumption, smoking, cannabis and other illegal drugs
| Study group | Role | What they receive |
|---|---|---|
| Norwegian University students | Norwegian fulltime University students Receives: Other: Lifestyle behaviour (exposure in a observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care utilisation due to musculoskeletal pain
Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a musculoskeletal pain diagnosis (yes/no and number of visits)
Measured: 3 years (6 Apr 2018 - 6 Apr 2021)
Secondary outcomes (2)
Health care utilisation due to back pain
Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a back pain diagnosis
Measured: 3 years (6 Apr 2018 - 6 Apr 2021)
Health care utilisation due to neck pain
Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a neck pain diagnosis
Measured: 3 years (6 Apr 2018 - 6 Apr 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start6 Feb 2018
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
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
- 50,054 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britt Elin Øiestad, Oslo Metropolitan University
- Investigators
- Britt Elin Øiestad, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157112
- Sponsor's protocol ID
- 251771
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Students' Lifestyle Behaviour and Later Health Care Utilization Due to Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT06157112
- Acronym / sponsor ID
- 251771
- Conditions
- Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,054 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 5 Dec 2023 (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.
This study aims to assess whether there is an association between students' lifestyle behaviour, in terms of physical activity level, sleep duration, smoking status, alcohol consumption and use of cannabis and other illegal drugs, and later health care utilisation due to musculoskeletal pain. The study will combine data from a national survey in Norway (SHOT2018), in which all full-time university students in Norway were invited, with data from a register on health care utilisation in primary health care.
Detailed description
This study aims to determine:
- whether male and female university students' lifestyle behaviours, in terms of physical activity level, sleep durance, alcohol consumption, smoking and illicit drug use, are associated with future health care utilisation for musculoskeletal pain, back pain or neck pain, and ii) whether the number of adverse lifestyle behaviours is associated with future health care utilisation for musculoskeletal pain, back pain or neck pain.
Study design and setting:
Cohort study, in which data from the Students' Health and Wellbeing study (SHoT) is merged with data from the Norwegian Register of Primary Health Care (NRPHC).
The eligibility criteria:
Inclusion criteria • Participants of the SHoT2018 study (18-35 years of age)
Exclusion criteria
- Participants studying abroad
- Participants above 35 years of age
- Recent health care utilisation for a musculoskeletal pain diagnosis (the last 12 months prior to the exposure assessment)
Primary outcome:
- Health care utilisation for musculoskeletal pain in primary health care, registered in the NRPHC (follow-up period: 3 years after baseline)
Secondary outcome:
- Health care utilisation for back pain, registered in NRPHC (follow-up period: 3 years after baseline)
- Health care utilisation for neck pain, registered in NRPHC (follow-up period: 3 years after baseline)
Exposures:
- Physical activity, obtained from the SHOT-questionnaire, categorised in accordance with recommendations for weekly physical activity
- Sleep duration, obtained from the SHOT-questionnaire, categorised in accordance with recommendations
- Smoking (yes / no)
- Alcohol consumption (assessed with AUDIT)
- Illegal drug use (categorised in use the last year yes/no)
- Number of adverse lifestyle behaviours (0-5) (low physical activity, short sleep duration, smoking, risky alcohol use, illegal drug use the last year)
Potential confounders:
The following variables will be considered as potential confounders in the analyses: age, financial difficulties, physical health complaints, symptoms of depression and anxiety, BMI, other lifestyle behaviours, consultation frequency irrespective of cause, the last year prior baseline (the last will be used as an indicator of health care seeking behaviour)
Statistical analyses:
3-year incidence rates of health utilisation for musculoskeletal pain, back pain and neck pain will be computed
Crude and adjusted associations between each of the lifestyle behaviours and health care utilisation for musculoskeletal pain, back pain and neck pain will be assessed separately. Also, the association between the number of adverse lifestyle behaviours and musculoskeletal pain, back and neck pain will be assessed in crude and adjusted analyses. Modified Poisson regression will be used to analyse the associations with binary outcomes (health care utilisation for musculoskeletal pain yes/no). To asses the associations with an outcome variable reflecting the number of health care visits for musculoskeletal pain, the exact statistical analysis method will be chosen after inspection of the distribution of the outcome data. All analyses will be conducted stratified by sex.
The following sensitivity analyses will be considered:
- analyses stratified by baseline musculoskeletal pain status
- only including outcome data before 12 March 2020 to assess the associations prior to the Covid 19 restrictions
- excluding participants above 30 years of age to assess the associations in a sample of students withing the \"emerging adult\" definition (up to 30 years of age)
All analyses will be conducted with STATA statistical software system, version 16 (StataCorp., 2019)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norwegian University students | – | Other: Lifestyle behaviour (exposure in a observational study)Norwegian fulltime University students |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University full-time students, 18-35 years of age
Key inclusion criteria (1 listed)
- All full-time Norwegian University students aged 18 to 35 years of age
Key exclusion criteria (3 listed)
- students studying abroad
- students above 35 years of age
- students with health care utilisation due to musculoskeletal pain the last 12 months before 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 |
|---|---|---|
| Lifestyle behaviour (exposure in a observational study)Lifestyle behaviour, including physical activity, sleep duration, alcohol consumption, smoking, cannabis and other illegal drugs | Other | Norwegian University students |
Primary outcome
Health care utilisation due to musculoskeletal pain
Time frame: 3 years (6 Apr 2018 - 6 Apr 2021)
Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a musculoskeletal pain diagnosis (yes/no and number of visits)
2 secondary outcomes
Health care utilisation due to back pain
Time frame: 3 years (6 Apr 2018 - 6 Apr 2021)
Health care utilisation due to neck pain
Time frame: 3 years (6 Apr 2018 - 6 Apr 2018)
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 2 Oct 2024.
- 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.
Britt Elin Øiestad, PhD principal investigator
Oslo Metropolitan University
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 3 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 2 Oct 2024. 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?
Health care utilisation due to musculoskeletal pain (time frame: 3 years (6 Apr 2018 - 6 Apr 2021)). 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 2 Oct 2024.