N/A N=55 Randomized Single-blind Treatment

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

Chronic Low Back Pain · Hip Ostearthritis · Myofascial Pain Syndrome · Fibromyalgia · Depression

Bottom Line

View on ClinicalTrials.gov: NCT02697435 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ) — -1.29; -0.08 score on a scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Patient-Centered Care (Other); Imaging-Directed Care (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)	-1.29; -0.08	<0.05 sig
PRIMARY Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale	0.46; 0.96	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02697435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.