Chronic Low Back PainNCT03564600
Aging Back Clinics
A study testing Aging Back Clinics management in people with Chronic Low Back Pain, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The purpose of this study is to compare two different ways to treat chronic low back pain. The two types of treatment that the investigators will compare are called Usual Care and ABC Care. Usual Care tends to focus on the spine. ABC Care focuses on the entire body and the mind. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Aging Back Clinics management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jan 2019to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older Veterans with CLBP, defined as pain in the lower back of at least moderate severity.
- assessed with a verbal rating scale on > half the days for > 6 months
- Veterans must be English speaking.
- Must be able to commit to 12 months of study participation.
- The Quick Mild Cognitive Impairment Screen (QMCI) will be administered on site to screen for mild cognitive impairment (MCI).
- Those with MCI will not be excluded, but their PCP will be alerted.
Who cannot join
- Positive screen for dementia (score <23 on the MMSE)
- Pain in other body locations that is more severe than their low back pain
- Red flags indicative of serious underlying illness requiring urgent care
- e.g., fever, change in bowel/bladder function, sudden severe change in pain, unintentional weight loss, new lower extremity weakness
- Previous lumbar surgery.
- Acute illness.
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- Psychotic symptoms.
- Prohibitive communication impairment.
- e.g., severe hearing or visual impairment.
- Neither pregnant subjects nor women of childbearing potential will be included due to the age requirements of the study.
- Vulnerable subjects will not be enrolled, nor children and prisoners.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Optimizing Outcomes for Older Veterans With Chronic Low Back Pain Syndrome: Aging Back Clinics
The purpose of this study is to compare two different ways to treat chronic low back pain. The two types of treatment that the investigators will compare are called Usual Care and ABC Care. Usual Care tends to focus on the spine. ABC Care focuses on the entire body and the mind. With Usual Care, participants will work with their own doctor to come up with a treatment plan. With ABC Care, participants will work with the investigators' ABC providers and their team. The investigators believe ABC Care will help reduce pain, lower costs, and increase participants' ability to do the things they enjoy doing better than Usual Care. In ABC Care the investigators hope to avoid treatments like surgeries where participants get metal rods put in their back.
This research is being done at three Veterans Hospitals: the Veterans Administration of Pittsburgh Healthcare System (VAPHS) in Pittsburgh, PA; the North Texas VA Medical Center in Dallas, TX; and the Hunter Holmes McGuire VA Medical Center in Richmond, VA. This research study is being paid for by the Rehabilitation Research and Development section of the Veterans Health Administration.
The investigators will be enrolling about 450 participants at 3 sites or around 150 at each site.
Read the detailed description
Degenerative disease of the lumbar spine is ubiquitous in older adults, but low back pain is not. Treatments that focus exclusively on degenerative spine disease, such as spinal injection and surgery, have resulted in rising costs and exposure to potentially life-threatening morbidity but outcomes have not improved. The investigators posit that to improve treatment outcomes for older adults with chronic low back pain (CLBP - back pain that has been present on at least half the days for at least 6 months), the condition should be approached as a syndrome, that is, a final common pathway for the expression of many contributors, in the same way that geriatricians approach the evaluation and treatment of delirium and falls. Using this model, the lumbar spine is considered a weak link, but is rarely the sole treatment target. Conditions that commonly contribute to pain and disability in older adults with CLBP include hip osteoarthritis, fibromyalgia, anxiety, maladaptive coping, and myofascial pain, each of which is associated with specific evidence-based treatments. Because such conditions are not routinely evaluated in patients with CLBP, it is perhaps not surprising that first line treatments that do not specifically target multiple contributors (e.g. spine-focused physical therapy and analgesics) often provide suboptimal treatment outcomes. This often results in continued treatment-seeking including potentially toxic medications and invasive, expensive, and potentially life-threatening procedures such as complex spinal fusion.
The central question that the proposed randomized trial is designed to answer is: What is the efficacy of caring for older adults with CLBP in Aging Back Clinics (ABC), where the patient is first treated as an older adult, and second as a patient with CLBP, compared with usual care (UC)? The investigators have developed evidence and expert-opinion based guidelines for the evaluation and treatment of 12 key contributors to pain and disability in older adults with CLBP. The investigators' prior work also supports the commonplace nature of multiple contributors to CLBP in older Veterans and the feasibility of delivering patient-centered comprehensive care that follows the investigators' published guidelines. The investigators now wish to implement these guidelines in the investigators' ABC clinics and compare this approach to that of UC in older Veterans. Proof of the hypotheses could significantly impact patient care by reducing pain and disability and identifying key conditions whose treatment could prevent the pursuit of invasive treatments and their associated potential morbidity and cost.
About 450 Veterans age 65-89 with CLBP will be recruited from primary care provider practices at 3 VAs - VA Pittsburgh Healthcare System, Dallas VA, and Richmond VA to meet a target randomization of 330. Individuals will be randomized to receive either ABC care or UC and they will be followed for one year. Those in ABC care will be referred to a generalist (e.g., geriatrician, physiatrist, rheumatologist) that has been identified and trained in a structured assessment to identify the conditions for which evidence and expert opinion-based algorithms have been created. Usual care will not be constrained. Outcomes will be assessed at baseline and over the telephone at three later time points: 6 months, 9 months and 12 months. Health Care Utilization will be assessed monthly. Gait speed, a strong predictor of morbidity and mortality in older adults, will be measured at baseline. The proposed clinical trial has the potential not only to improve pain-related disability, but also to reduce morbidity, increase quality of life, and limit healthcare utilization.
- Conditions
- Chronic Low Back Pain
- Being tested
- Aging Back Clinics management
- Keywords
- low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aging Back Clinics managementOther
Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.
| Study group | Role | What they receive |
|---|---|---|
| ABC Group | Experimental | Veterans with back pain for at least the past 6 months receive personalized care by providers trained based on a published set of algorithms that guide care for conditions that contribute to disability in older adults with chronic low back pain Receives: Other: Aging Back Clinics management |
| UC Group | No intervention | Veterans with back pain for at least the past 6 months who receive usual care as directed by their primary care physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) Change
The ODI assesses interference of pain with function. This questionnaire is used by clinicians and researchers to quantify disability for low back pain. Range 0 to 100 with higher score indicating greater disability.
Measured: Baseline visit, every three months for up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start3 Jan 2019
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Debra K. Weiner, MD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564600
- Sponsor's protocol ID
- O2808-R
- Status last verified
- Mar 2025
- First submitted
- 11 Jun 2018
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Outcomes for Older Veterans With Chronic Low Back Pain Syndrome: Aging Back Clinics
- ClinicalTrials.gov ID
- NCT03564600
- Acronym / sponsor ID
- O2808-R
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two different ways to treat chronic low back pain. The two types of treatment that the investigators will compare are called Usual Care and ABC Care. Usual Care tends to focus on the spine. ABC Care focuses on the entire body and the mind. With Usual Care, participants will work with their own doctor to come up with a treatment plan. With ABC Care, participants will work with the investigators' ABC providers and their team. The investigators believe ABC Care will help reduce pain, lower costs, and increase participants' ability to do the things they enjoy doing better than Usual Care. In ABC Care the investigators hope to avoid treatments like surgeries where participants get metal rods put in their back.
This research is being done at three Veterans Hospitals: the Veterans Administration of Pittsburgh Healthcare System (VAPHS) in Pittsburgh, PA; the North Texas VA Medical Center in Dallas, TX; and the Hunter Holmes McGuire VA Medical Center in Richmond, VA. This research study is being paid for by the Rehabilitation Research and Development section of the Veterans Health Administration.
The investigators will be enrolling about 450 participants at 3 sites or around 150 at each site.
Detailed description
Degenerative disease of the lumbar spine is ubiquitous in older adults, but low back pain is not. Treatments that focus exclusively on degenerative spine disease, such as spinal injection and surgery, have resulted in rising costs and exposure to potentially life-threatening morbidity but outcomes have not improved. The investigators posit that to improve treatment outcomes for older adults with chronic low back pain (CLBP - back pain that has been present on at least half the days for at least 6 months), the condition should be approached as a syndrome, that is, a final common pathway for the expression of many contributors, in the same way that geriatricians approach the evaluation and treatment of delirium and falls. Using this model, the lumbar spine is considered a weak link, but is rarely the sole treatment target. Conditions that commonly contribute to pain and disability in older adults with CLBP include hip osteoarthritis, fibromyalgia, anxiety, maladaptive coping, and myofascial pain, each of which is associated with specific evidence-based treatments. Because such conditions are not routinely evaluated in patients with CLBP, it is perhaps not surprising that first line treatments that do not specifically target multiple contributors (e.g. spine-focused physical therapy and analgesics) often provide suboptimal treatment outcomes. This often results in continued treatment-seeking including potentially toxic medications and invasive, expensive, and potentially life-threatening procedures such as complex spinal fusion.
The central question that the proposed randomized trial is designed to answer is: What is the efficacy of caring for older adults with CLBP in Aging Back Clinics (ABC), where the patient is first treated as an older adult, and second as a patient with CLBP, compared with usual care (UC)? The investigators have developed evidence and expert-opinion based guidelines for the evaluation and treatment of 12 key contributors to pain and disability in older adults with CLBP. The investigators' prior work also supports the commonplace nature of multiple contributors to CLBP in older Veterans and the feasibility of delivering patient-centered comprehensive care that follows the investigators' published guidelines. The investigators now wish to implement these guidelines in the investigators' ABC clinics and compare this approach to that of UC in older Veterans. Proof of the hypotheses could significantly impact patient care by reducing pain and disability and identifying key conditions whose treatment could prevent the pursuit of invasive treatments and their associated potential morbidity and cost.
About 450 Veterans age 65-89 with CLBP will be recruited from primary care provider practices at 3 VAs - VA Pittsburgh Healthcare System, Dallas VA, and Richmond VA to meet a target randomization of 330. Individuals will be randomized to receive either ABC care or UC and they will be followed for one year. Those in ABC care will be referred to a generalist (e.g., geriatrician, physiatrist, rheumatologist) that has been identified and trained in a structured assessment to identify the conditions for which evidence and expert opinion-based algorithms have been created. Usual care will not be constrained. Outcomes will be assessed at baseline and over the telephone at three later time points: 6 months, 9 months and 12 months. Health Care Utilization will be assessed monthly. Gait speed, a strong predictor of morbidity and mortality in older adults, will be measured at baseline. The proposed clinical trial has the potential not only to improve pain-related disability, but also to reduce morbidity, increase quality of life, and limit healthcare utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABC Group | Experimental | Other: Aging Back Clinics managementVeterans with back pain for at least the past 6 months receive personalized care by providers trained based on a published set of algorithms that guide care for conditions that contribute to disability in older adults with chronic low back pain |
| UC Group | No intervention | –Veterans with back pain for at least the past 6 months who receive usual care as directed by their primary care physician. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Older Veterans with CLBP, defined as pain in the lower back of at least moderate severity.
- Veterans must be English speaking.
- Must be able to commit to 12 months of study participation.
- The Quick Mild Cognitive Impairment Screen (QMCI) will be administered on site to screen for mild cognitive impairment (MCI).
Key exclusion criteria (11 listed)
- Positive screen for dementia (score <23 on the MMSE)
- Pain in other body locations that is more severe than their low back pain
- Red flags indicative of serious underlying illness requiring urgent care
- Previous lumbar surgery.
- Acute illness.
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 |
|---|---|---|
| Aging Back Clinics managementPersonalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider. | Other | ABC Group |
Primary outcome
Oswestry Disability Index (ODI) Change
Time frame: Baseline visit, every three months for up to one year
The ODI assesses interference of pain with function. This questionnaire is used by clinicians and researchers to quantify disability for low back pain. Range 0 to 100 with higher score indicating greater disability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Debra K. Weiner, MD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aging Back Clinics management in people with Chronic Low Back Pain, run by VA Office of Research and Development at 3 sites 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 6 inclusion and 11 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oswestry Disability Index (ODI) Change (time frame: Baseline visit, every three months for up to one year). 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 20 Mar 2025.