NCT04249453

Lower Back Biomechanics in Veterans With Non-Specific Low Back Pain

Completed Last updated 1 November 2024

What this trial tests

trial in Chronic Low Back Pain in 23 participants. Completed in 14 December 2022.

Timeline

15 January 2021

Primary endpoint
13 December 2022

14 December 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Status	Completed
Study type	OBSERVATIONAL
Enrollment	23
Start date	15 January 2021
Primary completion	13 December 2022
Estimated completion	14 December 2022
Sites	1 location across United States

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 21 to 70, any sex, with Chronic Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 and spinal loads in the clinical presentation of LBP. Such an understanding has the potential to help the affected Veterans with disabling non-specific LBP. Specifically, measures of lower back MB and spinal loads can be used not only to identify Veterans with mechanical abnormalities in their lower back who are likely to experience LBP in the future, but also to guide novel integrated physical and psychological preventative treatments aimed at improved lower back mechanics. Ultimately, the goal and resultant improvement in clinical outcomes of treatment for non-specific LBP is to diminish reliance on opioids for the symptom management of particularly Veterans with chronic LBP.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.