Musculoskeletal PainNCT06494670
Trends in Prevalence of 11 Site-specific Musculoskeletal Pain Among U.S. Adults, 1999-2018
An observational study of Musculoskeletal Pain and Neck Pain, run by Fan luying.
Trial summary
The goal of this observational study is to explore the prevalence trends of 11 site-specific musculoskeletal pain from 1999 to 2018. The main question it aims to answer is: Does the prevalence of musculoskeletal pain among U.S. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Musculoskeletal Pain, Neck Pain, Low Back Pain
- How many people
- 565,219 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 31 Dec 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The National Health Interview Survey (NHIS) is a national survey conducted by the U.S. Census Bureau on behalf of the National Center for Health Statistics (NCHS). NHIS is the principal source of information on the health of the civilian noninstitutionalized population of the United States. The target population for the NHIS is the civilian noninstitutionalized population residing within the 50 states and the District of Columbia at the time of the interview. NCHS is bound by law to protect participant data, following rigorous privacy standards that have protected every NHIS participant since the first survey in 1957. Base on NHIS data, we included adults aged 18 years and older who were interviewed in a survey wave between 1999 and 2018 in this study. From the total unweighted sample of 603,140 respondents, we excluded 37,921 due to missing data on independent variables or musculoskeletal pain, resulting in an analytic sample size of 565,219.
Who may be able to join
- Residents of households and noninstitutional group quarters (e.g., homeless shelters, rooming houses, and group homes);
- Persons residing temporarily in student dormitories or temporary housing are sampled within the households that they reside in permanently.
Who cannot join
- Persons with no fixed household address (e.g., homeless and/or transient persons not residing in shelters);
- Active duty military personnel and civilians living on military bases, persons in long-term care institutions (e.g., nursing homes for the elderly, hospitals for the chronically ill or physically or intellectually disabled, and wards for abused or neglected children);
- Persons in correctional facilities (e.g., prisons or jails, juvenile detention centers, and halfway houses), and U.S. nationals living in foreign countries.
About this study
Official title: Trends in Prevalence of 11 Site-specific Musculoskeletal Pain Among U.S. Adults, 1999-2018: a Cross-sectional Study
The goal of this observational study is to explore the prevalence trends of 11 site-specific musculoskeletal pain from 1999 to 2018. The main question it aims to answer is:
Does the prevalence of musculoskeletal pain among U.S. adults changed from 1999 to 2018? What are the trends?
Participants will answer survey questions about their musculoskeletal pain on the past three months.
Read the detailed description
Musculoskeletal (MSK) pain refers to pain, either acute or chronic, affecting muscles, bones, joints, tendons, and even nerves. Common types include low back pain, neck pain, and the pain associated with osteoarthritis. These pains are the leading cause of work disability, sick leave, presenteeism, and reduced productivity. MSK pain is the leading cause of disability in the United States in 2021, ranking first in years lived with disability and fourth in disability-adjusted life years. Moreover, MSK pain is often chronic and progressive, placing a considerable strain on healthcare systems and financial resources. Estimates of US healthcare spending in 2016 revealed that low back and neck pain had the highest costs, at $134.5 billion, followed by other MSK pain, which accounted for $129.8 billion.
As the U.S. population ages, the prevalence of MSK issues may rise, leading to increased demands on the healthcare system. Although the Bone and Joint Decade 2000-2010 raised awareness about the burden of MSK conditions, significant gaps in health system improvements persist. National health policies and strategies addressing MSK health as part of noncommunicable disease care remain inadequate relative to the burden of these condition such as cardiovascular disease. Achieving the 2030 Agenda for Sustainable Development and promoting health throughout life requires a renewed and sustained focus on improving MSK health at both national and global levels. Tracking the prevalence trends of MSK pain may offer valuable insights into critical public health issues, including shifts in disease burden, healthcare access, adoption of effective therapies, and reduction in the use of inappropriate or ineffective treatments. However, previous studies have mostly focused on low back pain, and neck pain. To date, very few studies have examined trends of site-specific MSK pain prevalence using national representative sample. Prevalence and trends in other sites are also important, but no relevant studies were found. The absence of such data poses challenges in accurately estimating the burden of MSK pain.
In addition, in disease trend analysis, temporal trends generally encompass multiple dimensions. For individuals with MSK pain, prevalence risk can be divided into age, period, and birth cohort effects. Age effects reflect the influence of an individual's chronological age on MSK pain prevalence. Period effects pertain to the influence of external factors on the whole population at a particular time. These factors may include changes in medical technology, public health policies, or social and economic conditions. Cohort effects reflect the impact of common experiences and exposures unique to a particular generation or birth cohort, regardless of period or age. Understanding the contribution of age-period-cohort effects and identifying potential moderating factors for each enhances comprehension of macro-level exposures, aiding in data-driven planning.
Furthermore, Healthy People 2010 and 2020, the U.S. national public health blueprint, targeted the elimination of health disparities, including those related to MSK pain, and the attainment of health equity. To assess progress toward this objective, it is crucial to evaluate disparities in MSK pain prevalence.
In this study, utilizing a large, nationally representative sample of the US population, our objective was to explore the prevalence trends of 11 site-specific MSK pain from 1999 to 2018. We also identified cohort patterns in MSK pain prevalence, isolating age, period and cohort effects. Furthermore, we also investigated these trends across various demographic factors such as race/ethnicity, gender, age, and socioeconomic status to determine whether health disparities persist.
- Conditions
- Musculoskeletal Pain, Neck Pain, Low Back Pain, Joint Pain, Shoulder Pain
- Being tested
- No intervention
- Keywords
- Musculoskeletal pain, Prevalence, Age-period-cohort effects
- Medical subject headings
- Musculoskeletal Pain, Neck Pain, Low Back Pain, Arthralgia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study was a cross-sectional study with no intervention for participants
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal pain
Participants aged 18 years or older were asked the following questions: "During the past three months, did you have [neck pain, low back pain, or jaw/front of ear pain]?" and "During the past 30 days, did you have joint pain?". Participants who answered affirmatively to joint pain were then asked to report the site of their joint pain. The options included shoulder, elbow, hip, wrist, knee, ankle, toes, and Participants aged 18 years or older were asked the following questions: "During the past three months, did you have [neck pain, low back pain, or jaw/front of ear pain]?" and "During the past 30 days, did you have joint pain?". Participants who answered affirmatively to joint pain were then asked to report the site of their joint pain. The included shoulder, elbow, hip, wrist, knee, ankle, toes, and fingers/thumb.
Measured: 1999-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Jan 1999
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 565,219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fan luying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fan luying, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494670
- Sponsor's protocol ID
- CSU202407
- Other IDs
- 82173608, 81974019, 2022JJ40207
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data utilized in this study was sourced from the National Health Interview Survey (NHIS), with the NHIS protocol having obtained approval from the NCHS Research Ethics Review Board. Additionally, written consent was secured from all participants prior to data collection. It should be noted that all data shared have been fully anonymized and do not contain any personal identifying information about the participants.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends in Prevalence of 11 Site-specific Musculoskeletal Pain Among U.S. Adults, 1999-2018: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06494670
- Acronym / sponsor ID
- CSU202407
- Conditions
- Musculoskeletal Pain, Neck Pain, Low Back Pain, Joint Pain, Shoulder Pain
- Keywords
- Musculoskeletal pain, Prevalence, Age-period-cohort effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 565,219 participants (estimated)
- Lead sponsor
- Fan luyingUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jul 2024 (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.
The goal of this observational study is to explore the prevalence trends of 11 site-specific musculoskeletal pain from 1999 to 2018. The main question it aims to answer is:
Does the prevalence of musculoskeletal pain among U.S. adults changed from 1999 to 2018? What are the trends?
Participants will answer survey questions about their musculoskeletal pain on the past three months.
Detailed description
Musculoskeletal (MSK) pain refers to pain, either acute or chronic, affecting muscles, bones, joints, tendons, and even nerves. Common types include low back pain, neck pain, and the pain associated with osteoarthritis. These pains are the leading cause of work disability, sick leave, presenteeism, and reduced productivity. MSK pain is the leading cause of disability in the United States in 2021, ranking first in years lived with disability and fourth in disability-adjusted life years. Moreover, MSK pain is often chronic and progressive, placing a considerable strain on healthcare systems and financial resources. Estimates of US healthcare spending in 2016 revealed that low back and neck pain had the highest costs, at $134.5 billion, followed by other MSK pain, which accounted for $129.8 billion.
As the U.S. population ages, the prevalence of MSK issues may rise, leading to increased demands on the healthcare system. Although the Bone and Joint Decade 2000-2010 raised awareness about the burden of MSK conditions, significant gaps in health system improvements persist. National health policies and strategies addressing MSK health as part of noncommunicable disease care remain inadequate relative to the burden of these condition such as cardiovascular disease. Achieving the 2030 Agenda for Sustainable Development and promoting health throughout life requires a renewed and sustained focus on improving MSK health at both national and global levels. Tracking the prevalence trends of MSK pain may offer valuable insights into critical public health issues, including shifts in disease burden, healthcare access, adoption of effective therapies, and reduction in the use of inappropriate or ineffective treatments. However, previous studies have mostly focused on low back pain, and neck pain. To date, very few studies have examined trends of site-specific MSK pain prevalence using national representative sample. Prevalence and trends in other sites are also important, but no relevant studies were found. The absence of such data poses challenges in accurately estimating the burden of MSK pain.
In addition, in disease trend analysis, temporal trends generally encompass multiple dimensions. For individuals with MSK pain, prevalence risk can be divided into age, period, and birth cohort effects. Age effects reflect the influence of an individual's chronological age on MSK pain prevalence. Period effects pertain to the influence of external factors on the whole population at a particular time. These factors may include changes in medical technology, public health policies, or social and economic conditions. Cohort effects reflect the impact of common experiences and exposures unique to a particular generation or birth cohort, regardless of period or age. Understanding the contribution of age-period-cohort effects and identifying potential moderating factors for each enhances comprehension of macro-level exposures, aiding in data-driven planning.
Furthermore, Healthy People 2010 and 2020, the U.S. national public health blueprint, targeted the elimination of health disparities, including those related to MSK pain, and the attainment of health equity. To assess progress toward this objective, it is crucial to evaluate disparities in MSK pain prevalence.
In this study, utilizing a large, nationally representative sample of the US population, our objective was to explore the prevalence trends of 11 site-specific MSK pain from 1999 to 2018. We also identified cohort patterns in MSK pain prevalence, isolating age, period and cohort effects. Furthermore, we also investigated these trends across various demographic factors such as race/ethnicity, gender, age, and socioeconomic status to determine whether health disparities persist.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The National Health Interview Survey (NHIS) is a national survey conducted by the U.S. Census Bureau on behalf of the National Center for Health Statistics (NCHS). NHIS is the principal source of information on the health of the civilian noninstitutionalized population of the United States. The target population for the NHIS is the civilian noninstitutionalized population residing within the 50 states and the District of Columbia at the time of the interview. NCHS is bound by law to protect participant data, following rigorous privacy standards that have protected every NHIS participant since the first survey in 1957. Base on NHIS data, we included adults aged 18 years and older who were interviewed in a survey wave between 1999 and 2018 in this study. From the total unweighted sample of 603,140 respondents, we excluded 37,921 due to missing data on independent variables or musculoskeletal pain, resulting in an analytic sample size of 565,219.
Key inclusion criteria (2 listed)
- Residents of households and noninstitutional group quarters (e.g., homeless shelters, rooming houses, and group homes);
- Persons residing temporarily in student dormitories or temporary housing are sampled within the households that they reside in permanently.
Key exclusion criteria (3 listed)
- Persons with no fixed household address (e.g., homeless and/or transient persons not residing in shelters);
- Active duty military personnel and civilians living on military bases, persons in long-term care institutions (e.g., nursing homes for the elderly, hospitals for the chronically ill or physically or intellectually disabled, and wards for abused or neglected children);
- Persons in correctional facilities (e.g., prisons or jails, juvenile detention centers, and halfway houses), and U.S. nationals living in foreign countries.
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 interventionThis study was a cross-sectional study with no intervention for participants | Other | – |
Primary outcome
Musculoskeletal pain
Time frame: 1999-2018
Participants aged 18 years or older were asked the following questions: "During the past three months, did you have [neck pain, low back pain, or jaw/front of ear pain]?" and "During the past 30 days, did you have joint pain?". Participants who answered affirmatively to joint pain were then asked to report the site of their joint pain. The options included shoulder, elbow, hip, wrist, knee, ankle, toes, and Participants aged 18 years or older were asked the following questions: "During the past three months, did you have [neck pain, low back pain, or jaw/front of ear pain]?" and "During the past 30 days, did you have joint pain?". Participants who answered affirmatively to joint pain were then asked to report the site of their joint pain. The included shoulder, elbow, hip, wrist, knee, ankle, toes, and fingers/thumb.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- The main objective of the NHIS is to monitor the health of the United States population through the collection and analysis of data on a broad range of health topics.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data utilized in this study was sourced from the National Health Interview Survey (NHIS), with the NHIS protocol having obtained approval from the NCHS Research Ethics Review Board. Additionally, written consent was secured from all participants prior to data collection. It should be noted that all data shared have been fully anonymized and do not contain any personal identifying information about the participants.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain and Neck Pain, run by Fan luying.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Musculoskeletal pain (time frame: 1999-2018). 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 16 Jul 2024.