Depression Clinical Trial
Official title:
Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP
Verified date | July 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | August 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 89 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | Hunter Holmes McGuire VA Medical Center, Richmond, VA | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Questionnaire is a 24 item yes/no measure of back pain interference with various daily activities. It is a well validated measure of low back pain disability. The total score ranges from 0 to 24 with a higher score meaning greater impairment. Our main outcome measure is reported as the change in Roland Morris score from baseline to 6 months. | Baseline and 6 months | |
Primary | Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale | Pain rated on a scale of 0 to 10, where 0 is no pain and 10 is worst possible pain. Outcome is change score. | Baseline and 6 months |
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