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NCT02697435 · ClinicalTrials.gov registry record · NA
Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)
A NA study of Depression and Insomnia, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 2
- Study locations
NCT02697435: Completed NA study of Depression and Insomnia, sponsored by VA Office of Research and Development.
NCT02697435 is a NA study of Depression and Insomnia that has completed, run by VA Office of Research and Development. The registered enrollment target is 55 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02697435, a NA study of Depression and Insomnia, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 2
- Study locations
Study 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 pai
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Patient-Centered Care
- OTHER Imaging-Directed Care
Study Locations (2)
Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2018-08-31 |
| Phase | NA |
What the finished NCT02697435 record still lists
NCT02697435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (93% lower).
The record links to 10 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Patient-Centered Care is the first listed.
NCT02697435 reports a single indexed study location in Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT02697435 about?
NCT02697435 is a clinical study titled "Making Better Lives: Patient-Focused Care for Low Back Pain (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 tho...
What is the current status of trial NCT02697435?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2016-04-01. Estimated completion is 2018-08-31.
What conditions does trial NCT02697435 study?
This clinical trial studies the following conditions: Depression, Insomnia, Fibromyalgia, Chronic Low Back Pain, Lumbar Spinal Stenosis.
What interventions are being tested in trial NCT02697435?
The interventions under investigation include: Patient-Centered Care (OTHER), Imaging-Directed Care (OTHER).
Who is sponsoring clinical trial NCT02697435?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02697435 being conducted?
This trial has 2 study locations across Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02697435's enrollment target sits among peer trials
55 456th of 679 higher than 224 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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