Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04249453 |
| Other study ID # |
F3300-P |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
December 14, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 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.
Description:
Specific Aims
The specific objective of this study is to generate evidence in support of the feasibility of
the investigators' developed methods for the evaluation of 1) relative contribution of lower
back tissues to spinal loads, and 2) the resultant spinal loads experienced during daily
activities in Veterans with non-specific LBP. Results of this feasibility study will enable
proper design of the investigators' future projects, wherein the investigators will
investigate the role of spinal loads experienced in daily life activities in clinical
presentation of LBP. The investigators have developed several innovative computational and
experimental methods for a comprehensive and personalized assessment of spinal loads.
Specifically, the relative mechanical contribution of active and passive lower back tissues
to spinal loads is assessed using advanced measures of bulk lower back mechanical behavior
(MB), whereas muscular responses to physical demands of daily activities and the resultant
spinal loads are evaluated using the investigators' finite element model of human spine. The
investigators have used the methods proposed in this application extensively for evaluation
of bulk lower back MB and spinal loads in asymptomatic individuals. This project will
demonstrate the sensitivity of the measures for capturing abnormalities in lower back MB and
spinal loads in patients with nonspecific LBP by completing the following two aims to achieve
the investigators' objective:
Aim-1: Feasibility of distinguishing potential differences in lower back MB between Veterans
with different LBP experiences. The investigators will characterize lower back MB in three
gender-balanced groups of Veterans between 20 and 70 years old. These will include Veterans
with 1) chronic LBP and a Roland-Morris Disability Questionnaire (RMDQ) score of >12 (n=18),
2) chronic LBP and RMDQ score of 12 (n=18), 3) no recent history of LBP and currently
asymptomatic (n=18), serving as control group). Participants will be recruited from the
population served by the Lexington, KY, VA Medical Center. The investigators will determine
passive stiffness of the lower back and its relaxation along with its active intrinsic and
reflexive mechanical properties, using the sudden perturbation and stress-relaxations tests.
Given the reported differences in trunk neuromuscular behavior and lumbo-pelvic coordination,
the investigators expect to see differences in the measures between patient groups targeted
for this project.
Aim-2: Feasibility of distinguishing potential differences in spinal loads between Veterans
with different LBP experiences. Trunk muscle forces and the resultant spinal loads will be
determined in the same participant groups when they perform common activities of daily living
like walking and manual material handling. Considering the causal role of spinal loads, and
given the persistence of symptom in patients with chronic LBP, along with the high risk of
LBP recurrence in patients with non-chronic LBP and those with a recent history of LBP, the
investigators expect differences in spinal loads between patient groups.
Research Procedures:
Participants deemed eligible will complete one data collection session during which they will
first be instrumented with sensors to enable measurement of kinematics and muscle activity,
similar to procedures the investigators used in earlier studies. Specifically, wireless
inertial measurement units (Xsens MTW, Xsens Technologies, Enschede, Netherlands) will be
used to measure rotations of the thorax and pelvis, and surface EMG electrodes will be used
to measure the activity of erector spinae, rectus abdominis, internal and external obliques.
Participants will then be asked to stand on a force plate and perform a forward bending and
backward return test. Participants will be instructed to bend from an upright standing
posture to their maximum comfortable forward bending posture and then return to the upright
posture at a self-selected pace. Participants will then be instructed to perform the
following activities of daily life at a self-selected pace: walking on level and sloped
surfaces, sit-to-stand and stand-to-sit motions, and lowering and lifting a 10 lb load to
their knee height. These activities have been selected because they represent basic but
repetitive activities of daily life, and the investigators have successfully used them in
earlier investigation of spinal loads among asymptomatic non-Veterans, as well as persons
with unilateral lower limb amputation. Finally, sudden perturbation followed by
stress-relaxation tests will be conducted as in earlier studies and as explained below. Each
of the above tests will take less than 5 minutes, and the investigators will provide break
periods between each set of tests to minimize fatigue and discomfort.
In preparation for future projects, the investigators will also administer the following
questionnaires that are relevant to LBP experience during the data collection session: 1)
comprehensive health status using the PROMIS-29 questionnaire (all participants), 2) survey
of habitual physical activity (all participants), 3) the short version of Copenhagen
Psychosocial questionnaire concerning work and non-work-related factors (all participants),
4) the minimum data set recommended by the NIH task force on research standards for chronic
LBP (only Veterans with LBP), 5) pain intensity using a numerical rating scale (only Veterans
with LBP), 6) LBP-related disability using the 24-item Roland Morris Disability Questionnaire
(only Veterans with LBP), 7) the fear-avoidance beliefs questionnaire (only Veterans with
LBP). Total time for the entire data collection session, including the instrumentation time,
is estimated to be less than 3 hours.
