An interventional study of Patient-Centered Care and Imaging-Directed Care in Chronic Low Back Pain, Hip Ostearthritis and Myofascial Pain Syndrome, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 60 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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:
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 55 is close to the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
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No red flags that would indicate a serious underlying disorder that would necessitate urgent and specialized treatment, i.e.,
Exclusion Criteria:
Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain.
Other: Patient-Centered Care
Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.
Other: Imaging-Directed Care
Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs.
Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.
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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and 6 months
Using an IRB-approved waiver of consent, research coordinators (RCs) screened CPRS records of Veterans age 60-89 with low back pain.Those eligible were mailed a study brochure and a letter signed by the chief of Primary Care. Additional screening was performed on those who called the RC. Those eligible were further screened on site.
| Milestone | Patient-Centered Care | Imaging-Directed Care |
|---|---|---|
| Started | 25 | 30 |
| Completed | 24 | 26 |
| Not completed | 1 | 4 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Physician decision | 0 | 4 |
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.
| score on a scale | Patient-Centered Care | Imaging-Directed Care |
|---|---|---|
| Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ) | -1.29 ± 6.05 | -0.08 ± 4.12 |
Pain rated on a scale of 0 to 10, where 0 is no pain and 10 is worst possible pain. Outcome is change score.
| units on a scale | Patient-Centered Care | Imaging-Directed Care |
|---|---|---|
| Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale | 0.46 ± 2.99 | 0.96 ± 2.18 |
Collected over through the duration of the study, up to 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient-Centered Care | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Imaging-Directed Care | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Patient-Centered Care | Imaging-Directed Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 12 | 16 |
| >=65 years | 21 | 18 | 39 |
| Age, Continuous(years) | Patient-Centered Care | Imaging-Directed Care | Total |
|---|---|---|---|
| Mean | 71.3 ± 7.5 | 67.2 ± 5.5 | 69.1 ± 6.7 |
| Sex: Female, Male(Participants) | Patient-Centered Care | Imaging-Directed Care | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 24 | 29 | 53 |
| Race (NIH/OMB)(Participants) | Patient-Centered Care | Imaging-Directed Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 9 | 17 |
| White | 17 | 20 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
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