Low Back PainNCT03632122
Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions
An observational study of Low Back Pain and Depression, run by University of Washington at 1 site in United States.
Trial summary
The overall goal of this study is to use the National Health and Aging Trends Study (NHATS) data to gain an understanding of how multiple chronic conditions impact the health outcomes of older adults with back pain. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Depression, Anxiety
- How many people
- 8,344 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 31 Jul 2019
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: NHATS is a cohort of older adults and is representative of Medicare beneficiaries age 65 and older. It is a "unique national resource for the scientific study of functioning in later life." The sample is drawn from the Medicare enrollment files, and the survey oversamples Blacks and those at older ages. Initial NHATS data collection began in 2011 (Round 1) with in-person interviews.
Who may be able to join
- This study will include community-dwelling participants in the NHATS study who indicated that in the last month they had been bothered by pain in the last month and indicated that the site of pain was the lower back.
Who cannot join
- This study will exclude participants who are non-ambulatory (requires wheelchair or scooter).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions to Inform Pathways of Care and Improve Population Health
The overall goal of this study is to use the National Health and Aging Trends Study (NHATS) data to gain an understanding of how multiple chronic conditions impact the health outcomes of older adults with back pain.
Read the detailed description
This study seeks to gain knowledge regarding how multiple chronic conditions affect the health and function of older adults with back pain. The investigators will perform a retrospective cohort study using secondary analysis of the National Health and Aging Trends Study (NHATS) data. NHATS collected longitudinal data on Medicare beneficiaries over 65 for six years, from 2011-2017. This set of data is comprehensive and includes self-reported survey data as well as physical performance data, both of which this study will utilize.
The specific aims include to 1) Estimate the longitudinal associations of the number of chronic conditions, using a standard classification scheme, with long-term physical performance, function, and recurrent falls, 2) Identify specific combinations of chronic conditions that are most strongly associated with long-term physical performance, function, and recurrent falls, 3) Determine the association of the number and type of chronic conditions with rehabilitation service use. The investigator will test a corresponding hypothesis for each aim: 1) Medicare beneficiaries reporting back pain with a greater number of chronic conditions will have worse physical performance, lower functional status, and be more likely to experience recurrent falls over 6 years, 2) Medicare beneficiaries reporting back pain with common and potentially modifiable conditions of anxiety, depression, and arthritis (individually and combined as dyads or a triad) will have worse physical performance, lower functional capacity, and be more likely to experience recurrent falls over 6 years, 3) Medicare beneficiaries with back pain and multiple chronic conditions will report lower use of rehabilitation services in the past one year compared to those with back pain alone or one additional chronic condition.
- Conditions
- Low Back Pain, Depression, Anxiety, Osteoarthritis
- Keywords
- comorbidity, pain, function, older adults, Medicare
- Medical subject headings
- Low Back Pain, Depression, Anxiety Disorders, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bothersome back pain | The investigators will include community-dwelling older adults at Round 1 or 6 of the NHATS cohort, and will include those with bothersome back pain in the past month based on self-report questions at the respective baseline time point. The investigators will exclude participants who are non-ambulatory (requires wheelchair or scooter). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
NHATS measures physical performance using an in-person physical performance test. The Short Physical Performance Battery, which includes walking 3 meters, balancing activities, and chair stands. Participants are scored from 0 (worst) to 12 (best).
Measured: 6 years
Rehabilitation Use
Participants asked if they had used rehabilitation services over the last year. This is a dichotomous variable of "use" or "no use". If participants answer that they have used rehabilitation services, they are asked the purpose/conditions for which they received care, the body region for which they received care, setting, duration of services in months and weeks, improvement of treatment and whether they met their treatment goals. These are reported as categorical variables.
Measured: 1 year
Secondary outcomes (4)
Walking Capacity
NHATS used survey questions asking about pairs of less or more challenging tasks. This includes walking. The pair of questions corresponding to walking capacity ask participants about their ability to walk 3 and 6 blocks by themselves. Based on their answers participants were put into one of the following categories: unable to do less challenging task able to do less challenging task, able to do less challenging but not more challenging task, able to do the more challenging task. Unable to do less challenging task the least functional capacity and able to do the most challenging task being the highest functional capacity. Higher functional capacity is the better outcome.
Measured: 6 years
Stair Climbing Capacity
NHATS used survey questions asking about pairs of less or more challenging tasks. This includes stair climbing. The pair of questions for stairs asks about the ability to go up 10 and 20 stairs. Based on their answers participants were put into one of the following categories: unable to do less challenging task able to do less challenging task, able to do less challenging but not more challenging task, able to do the more challenging task. Unable to do less challenging task the least functional capacity and able to do the most challenging task being the highest functional capacity. Higher functional capacity is the better outcome.
Measured: 6 years
Falls
The number of "falls" defined as "any fall, slip, or trip in which you lose your balance and land on the floor or ground at a lower level".
Measured: 6 years
Gait Speed
Participants are timed as they finish a three meter walking course.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Jul 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 8,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Rundell, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632122
- Sponsor's protocol ID
- STUDY00005260
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2018
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rundell SD, Karmarkar A, Patel KV. Associations of Co-Occurring Chronic Conditions With Use of Rehabilitation Services in Older Adults With Back Pain: A Population-Based Cohort Study. Phys Ther. 2024 Nov 1;104(11):pzae110. doi: 10.1093/ptj/pzae110.
PubMed 39151034Rundell SD, Karmarkar A, Nash M, Patel KV. Associations of Multiple Chronic Conditions With Physical Performance and Falls Among Older Adults With Back Pain: A Longitudinal, Population-based Study. Arch Phys Med Rehabil. 2021 Sep;102(9):1708-1716. doi: 10.1016/j.apmr.2021.03.025. Epub 2021 Apr 24.
PubMed 33901438
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions to Inform Pathways of Care and Improve Population Health
- ClinicalTrials.gov ID
- NCT03632122
- Acronym / sponsor ID
- STUDY00005260
- Conditions
- Low Back Pain, Depression, Anxiety, Osteoarthritis
- Keywords
- comorbidity, pain, function, older adults, Medicare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,344 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 15 Aug 2018 (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 overall goal of this study is to use the National Health and Aging Trends Study (NHATS) data to gain an understanding of how multiple chronic conditions impact the health outcomes of older adults with back pain.
Detailed description
This study seeks to gain knowledge regarding how multiple chronic conditions affect the health and function of older adults with back pain. The investigators will perform a retrospective cohort study using secondary analysis of the National Health and Aging Trends Study (NHATS) data. NHATS collected longitudinal data on Medicare beneficiaries over 65 for six years, from 2011-2017. This set of data is comprehensive and includes self-reported survey data as well as physical performance data, both of which this study will utilize.
The specific aims include to 1) Estimate the longitudinal associations of the number of chronic conditions, using a standard classification scheme, with long-term physical performance, function, and recurrent falls, 2) Identify specific combinations of chronic conditions that are most strongly associated with long-term physical performance, function, and recurrent falls, 3) Determine the association of the number and type of chronic conditions with rehabilitation service use. The investigator will test a corresponding hypothesis for each aim: 1) Medicare beneficiaries reporting back pain with a greater number of chronic conditions will have worse physical performance, lower functional status, and be more likely to experience recurrent falls over 6 years, 2) Medicare beneficiaries reporting back pain with common and potentially modifiable conditions of anxiety, depression, and arthritis (individually and combined as dyads or a triad) will have worse physical performance, lower functional capacity, and be more likely to experience recurrent falls over 6 years, 3) Medicare beneficiaries with back pain and multiple chronic conditions will report lower use of rehabilitation services in the past one year compared to those with back pain alone or one additional chronic condition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bothersome back pain | – | –The investigators will include community-dwelling older adults at Round 1 or 6 of the NHATS cohort, and will include those with bothersome back pain in the past month based on self-report questions at the respective baseline time point. The investigators will exclude participants who are non-ambulatory (requires wheelchair or scooter). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- NHATS is a cohort of older adults and is representative of Medicare beneficiaries age 65 and older. It is a "unique national resource for the scientific study of functioning in later life." The sample is drawn from the Medicare enrollment files, and the survey oversamples Blacks and those at older ages. Initial NHATS data collection began in 2011 (Round 1) with in-person interviews.
Key inclusion criteria (1 listed)
- This study will include community-dwelling participants in the NHATS study who indicated that in the last month they had been bothered by pain in the last month and indicated that the site of pain was the lower back.
Key exclusion criteria (1 listed)
- This study will exclude participants who are non-ambulatory (requires wheelchair or scooter).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: 6 years
NHATS measures physical performance using an in-person physical performance test. The Short Physical Performance Battery, which includes walking 3 meters, balancing activities, and chair stands. Participants are scored from 0 (worst) to 12 (best).
Rehabilitation Use
Time frame: 1 year
Participants asked if they had used rehabilitation services over the last year. This is a dichotomous variable of "use" or "no use". If participants answer that they have used rehabilitation services, they are asked the purpose/conditions for which they received care, the body region for which they received care, setting, duration of services in months and weeks, improvement of treatment and whether they met their treatment goals. These are reported as categorical variables.
4 secondary outcomes
Walking Capacity
Time frame: 6 years
Stair Climbing Capacity
Time frame: 6 years
Falls
Time frame: 6 years
Gait Speed
Time frame: 6 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 19 Aug 2019.
- Derived from this study: PubMed 39151034Rundell SD, Karmarkar A, Patel KV. Associations of Co-Occurring Chronic Conditions With Use of Rehabilitation Services in Older Adults With Back Pain: A Population-Based Cohort Study. Phys Ther. 2024 Nov 1;104(11):pzae110. doi: 10.1093/ptj/pzae110.
- Derived from this study: PubMed 33901438Rundell SD, Karmarkar A, Nash M, Patel KV. Associations of Multiple Chronic Conditions With Physical Performance and Falls Among Older Adults With Back Pain: A Longitudinal, Population-based Study. Arch Phys Med Rehabil. 2021 Sep;102(9):1708-1716. doi: 10.1016/j.apmr.2021.03.025. Epub 2021 Apr 24.
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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 Low Back Pain and Depression, run by University of Washington at 1 site in United States.
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 19 Aug 2019. 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 United States. 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?
Short Physical Performance Battery (SPPB) (time frame: 6 years). The study lists 2 primary outcomes in all. 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 NCT03632122, which also lists 2 linked publications.
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 19 Aug 2019.