Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)
Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP
2 other identifiers
interventional
55
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedResults Posted
Study results publicly available
August 19, 2019
CompletedAugust 19, 2019
July 1, 2019
2.2 years
February 12, 2016
April 30, 2019
July 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Patient-Centered Care
EXPERIMENTALPatient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain.
Imaging-Directed Care
PLACEBO COMPARATORImaging-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Debra Kaye Weiner, M.D.
- Organization
- VAPHS
Study Officials
- PRINCIPAL INVESTIGATOR
Debra K. Weiner, MD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Research Coordinators who perform the "data measure" portion of the baseline are masked from knowing which group (usual care or patient care) the participant ends up in. This is also true of monthly follow-up calls.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2016
First Posted
March 3, 2016
Study Start
April 1, 2016
Primary Completion
May 31, 2018
Study Completion
August 31, 2018
Last Updated
August 19, 2019
Results First Posted
August 19, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share