Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)



Status:Completed
Conditions:Anxiety, Anxiety, Back Pain, Back Pain, Depression, Fibromyalgia, Insomnia Sleep Studies, Neurology, Orthopedic, Orthopedic, Pain
Therapuetic Areas:Musculoskeletal, Neurology, Psychiatry / Psychology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:60 - 89
Updated:9/15/2018
Start Date:April 1, 2016
End Date:August 31, 2018

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Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP

Back pain is a huge problem for millions of Americans, including nearly 11 million Veterans.
Our older Veterans suffer the most. Citizens spend billions of dollars, yet consistently get
poor results. Primary Care Providers are often tasked with diagnosing and treating Chronic
Low Back Pain, even though they are often undereducated in the field. These PCPs often use
advanced imaging, usually MRIs to guide care. These images often show degenerative disc
disease and other common pathologies in older adults, even those who are pain free, which can
lead to misdiagnosis and treatment. The investigators believe that Chronic Low Back Pain is a
syndrome, a final common pathway for the expression of multiple contributors that often lie
outside the spine itself. For example, hip osteoarthritis, knee pain, and even anxiety could
all lessen back pain if addressed and treated probably.

Investigators will measure participants' low back pain-associated disability with the
well-validated RMDQ. Data will be collected at baseline and monthly via telephone. The
investigators hypothesize that veterans who receive PCCET will experience significantly
greater reduction in low back pain-associated disability than those who receive IAUC at six
months.

Investigators will also measure participants' low back pain with the 0-10 Numeric Rating
Scale for Pain. Data will be collected at baseline and monthly via telephone. The
investigators hypothesize that veterans who receive PCCET will experience significantly
greater reduction in low back pain than those who receive IAUC at six months.

The goal of this study is to compare patients treated with usual care, which usually starts
with imaging, versus patients who are treated by trained geriatricians who know how to
recognize and address 11 key conditions that commonly drive pain and disability in older
adults. The investigators believe that older patients who receive care tailored to their
needs by educated PCPs will ultimately have less back pain and, more importantly, better
quality of life.

Nearly half of our 22 million US military Veterans are age 65 and older and, within this
population, low back pain is common, costly and often disabling. The prevalence of low back
pain in those 85+, the most vulnerable and fastest growing segment of society, is estimated
at 44%. Chronic low back pain (CLBP, i.e., present for 6 months or more) is associated with
the overwhelming majority of healthcare resource utilization and personal suffering. Treating
back problems cost Americans more than $30 billion in 2007- up from $16 billion in 1997 (in
2007 dollars). Despite these staggering data, there is no evidence that the care of patients
with CLBP has improved, and the use of invasive, potentially morbid, and often ineffective
interventions (e.g., epidural corticosteroid injections and spine surgery) continues to
skyrocket. Primary care providers (PCP) who are tasked with treating CLBP without adequate
education often use advanced imaging (most commonly magnetic resonance imaging [MRI]) to
guide care. Imaging-identified pathology (e.g., degenerative disc and facet disease, bulging
discs) is ubiquitous in older adults, even in those that are pain-free. It is not surprising,
therefore, that imaging-guided treatments often lead to suboptimal outcomes and potential
morbidity. In contrast to how CLBP is often conceptualized and treated, the investigators
conceptualize CLBP as a syndrome, that is, a final common pathway for the expression of
multiple contributors that often lie outside the spine itself, for example, hip
osteoarthritis, fibromyalgia syndrome, and anxiety. Treating CLBP and ameliorating disability
in older adults necessitates addressing multiple conditions and risk factors; however, the
expertise to evaluate and treat all of the disorders that can contribute to CLBP typically
resides in multiple specialty silos, making a comprehensive approach to treating CLBP
difficult to implement.

Through the support of a 2-year Rehab R&D Merit Review pilot award, the investigators have
laid the essential foundation for delivering more comprehensive and patient-centric care to
older Veterans with CLBP. The investigators have:

- 1) synthesized, through a modified Delphi process, evidence on evaluating and treating
11 key conditions that commonly drive pain and disability in older adults with CLBP

- 2) created algorithms to be used in the clinical setting to treat these 11 conditions

- 3) successfully trained geriatrician providers in a practical structured assessment of
the 11 conditions, and

- 4) validated the prevalence of these conditions specifically in older Veterans

In the current application, the investigators are proposing a 2-site pilot study to explore
the impact of delivering patient-centered comprehensive evaluation and treatment (PCCET) as
compared with imaging-associated usual care (IAUC) to older Veterans with CLBP. In addition
to examining whether PCCET is more effective than IAUC for reducing pain and functional
limitations when delivered by geriatricians in 2 VA medical centers, the investigators will
evaluate PCCET's impact on health-related quality of life and health care utilization. The
investigators also will collect data to identify barriers and facilitators to implementing
PCCET from the perspective of patients and providers.

Inclusion Criteria:

- English-speaking (to ensure the validity of data collected)

- Age 60 and older

- Lumbar MRI within past 30 days and is without evidence of infection, malignancy, or
acute fracture OR scheduled for a lumbar MRI within the next 30 days

- CLBP, defined as pain in the lower back of at least moderate severity (assessed with a
verbal rating scale), every day or almost every day, for at least 3 months

- No red flags that would indicate a serious underlying disorder that would necessitate
urgent and specialized treatment, i.e.,

- weight loss

- fever

- sudden severe LBP

- change in bowels/bladder

- back pain that awakens from sleep

- recent leg weakness

- No pain in other body locations that is more severe than their low back pain

- No psychotic symptoms

- No previous spine surgery

- No dementia (Folstein Mini-Mental State Examination score of > 24)

- No acute illness

- No prohibitive communication impairment (e.g., severe hearing or visual impairment)

- Able to commit to 6 months of study participation

Exclusion Criteria:

- Vulnerable subjects will not be enrolled

- Neither pregnant subjects nor women of childbearing potential will be included because
the investigators are targeting older Veterans with CLBP

- Neither children nor prisoners will be included

- Incompetent subjects will be excluded from participating in this research, as
determined by performance on the Folstein Mini Mental State Examination
We found this trial at
2
sites
Richmond, Virginia 23249
Phone: 804-675-5428
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Richmond, VA
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Pittsburgh, Pennsylvania 15240
Principal Investigator: Debra K. Weiner, MD
Phone: 412-360-2913
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Pittsburgh, PA
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