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NCT04249453 · ClinicalTrials.gov registry record
Lower Back Biomechanics in Veterans With Non-Specific Low Back Pain
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 23
- Enrollment target
NCT04249453: Completed study, sponsored by VA Office of Research and Development.
NCT04249453 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04249453 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 23 participants
- Enrollment target
Study Summary
Low back pain (LBP) is strongly associated with opioid consumption among Veterans, and improved clinical management of LBP is likely to reduce reliance on opioid among Veterans. Up to 60% of patients with an acute episode of nonspecific LBP experience either symptom persistence or symptom relapse within one year. This is likely an indication of a failure in addressing the underlying mechanisms of pain or initiation of a new etiology; both may stem from a mismatch between patients and treatments. The overall goal of this research is to develop, validate and implement measures that are relevant to known mechanisms of LBP, which can then be used to holistically gauge the health status of patients' lower backs beyond self-reporting of symptoms. More accurate measurements will help better match of patients with existing treatments or development of more effective new treatments. The specific objective of this study is to generate evidence in support of the feasibility of the investigators' methods for 1) the evaluation of relative contribution of lower back tissues to spinal loads, and 2) the investigation of the resultant spinal loads in Veterans with non-specific LBP. The investigators have developed a powerful set of tools for the comprehensive assessment of spinal loads and lower back mechanical behavior (MB), that will enable the investigators to examine the existence or development of abnormalities in spinal loads and lower back MB in three groups of Veterans with different experiences with non-specific LBP. These groups will include 1) Veterans with chronic, non-specific LBP and high level of disability (n=18), 2) Veterans with chronic, non-specific LBP and low level of disability (n=18), 3) asymptomatic Veterans without a recent history of non-specific LBP (n=18; serving as control group). Successful completion of this feasibility project will pave the way for future studies (merit grant applications) that will verify the role of abnormalities in lower back MB an
Primary Outcome
The maximum spinal load experienced at the L5-S1 level during each activity. This measure is estimated by our finite element model. The input to the model will be measurements of trunk and pelvis motion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2022-12-14 |
What the finished NCT04249453 record still lists
NCT04249453 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 23 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04249453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04249453 about?
NCT04249453 is a clinical study titled "Lower Back Biomechanics in Veterans With Non-Specific Low Back Pain". Low back pain (LBP) is strongly associated with opioid consumption among Veterans, and improved clinical management of LBP is likely to reduce reliance on opioid among Veterans. Up to 60% of patients with an acute episode of nonspecific LBP experience either symptom persistence or symptom relapse wi...
What is the current status of trial NCT04249453?
This trial is currently completed. The enrollment target is 23 participants. The study started on 2021-01-15. Estimated completion is 2022-12-14.
Who is sponsoring clinical trial NCT04249453?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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