Whole Body Vibration for Spinal Degeneration

CV
AS
Overseen ByAlok Shah, MS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Milwaukee VA Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Significance to VA: There is a lack of prospective longitudinal studies investigating the relationship between risk factors to Veterans and development and progression of musculoskeletal (MSK) spine injury and pain. Military operational exposure to whole body vibration (WBV) is known to contribute to MSK disorders and pain. Our preliminary studies identified accelerated lumbar and cervical spine degenerative changes in military fighter pilots and helicopter aircrew compared to age- and sex-matched civilian controls. Those changes were likely associated with WBV that military aircrew experience during flight training, primarily affected intervertebral discs (IVDs) and endplates, were associated with neck and back pain symptoms and reduced functional capacity, and are likely to lead to lifelong spine-related issues. Therefore, these aircrew, and other military personnel that experience occupational WBV, are likely to enter the VA Healthcare system with pre-existing degenerative changes and spine-related pain symptoms that can progress over time. Similarly, many Veterans enter civilian occupations that involve WBV such as truck drivers and heavy equipment operators that may also have detrimental effects to the spine and lead to spine-related pain. Development of informed interventions and treatment protocols requires a mechanistic understanding of how the spine is acutely and chronically affected by occupational WBV from both structural and physiological perspectives. Innovation and Impact: Novel multi-parametric application of noninvasive magnetic resonance imaging (MRI) techniques such as arterial spin labeling (ASL), T2\* decay from ultra short TE, and diffusion MRI can provide early objective indications of endplate degenerative state and IVD hydration and perfusion, and novel application of upright MR imaging allows for gravitational loading of the IVD while observing segmental and region IVD fluid distribution and transport patterns. Specific Aims: The goal of the proposed effort is to characterize the effects of previous military and current civilian occupational WBV on IVD and endplate health and degeneration (Aim 1), and segmental and regional IVD fluid distribution and transport differences (Aim 2). The endplates contain vasculature that permits IVD fluid exchange and may be linked to IVD fluid dynamics. We propose looking for connections between segmental and regional IVD fluid dynamics, degenerative state of the associated endplates, and WBV exposure (acute-controlled and longitudinal-occupational). Finally, we propose evaluating the impact of body hydration state on IVD fluid distribution and transport following acute (30 min) controlled WBV (Aim 3). Cumulatively, these results inform population-specific preventative measures to preserve endplate health for Veterans in occupations that present with WBV and identify potential areas for further research and targeted treatment of MSK disorders and MSK pain. Methodology: This study will explore acute and chronic changes to the structure and physiology of the spine by enrolling Veterans with prior military or current civilian occupation that involves daily WBV. Advanced MRI sequences will identify endplate sclerosis and physiological changes including disc hydration and perfusion. Acute effects of WBV will be assessed using pre/post MRI scans with experimental WBV. Path to translation/Implementation: Our existing relationships with VA clinicians, including spine surgeons, physical medicine and rehabilitation, and pain medicine, will ensure VA patient applicability of these findings and will help to translate any outcomes from this research and future studies directly into patient care.

Who Is on the Research Team?

BD

Brian D Stemper, PhD

Principal Investigator

Milwaukee VA Medical Center

Are You a Good Fit for This Trial?

This trial is for U.S. military veterans aged 20-45 who can speak English, have a BMI under 30, can sit upright for an hour, drive to Deerfield, IL, and are able to walk on their own.

Inclusion Criteria

I am a veteran aged 20-45, with a BMI under 30, can sit upright for an hour, drive to Deerfield, IL, and can walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial MRI scans and questionnaires to assess baseline spine health and whole body vibration exposure history

1-2 weeks
1 visit (in-person)

Acute WBV Exposure

Participants undergo experimental whole body vibration exposure and pre/post MRI scans to assess acute changes

1 day
1 visit (in-person)

Longitudinal Monitoring

Annual MRI scans and questionnaires to track progression of spine changes over three years

3 years
3 visits (in-person, annually)

Follow-up

Participants are monitored for safety and effectiveness after the main study phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Water

Trial Overview

The study uses advanced MRI techniques to examine the spine's structure and physiology after exposure to whole body vibration (WBV), both from past military service and current civilian jobs like truck driving.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Effect of hydration on lumbar spine response to whole body vibrationExperimental Treatment1 Intervention
Group II: Longitudinal effects of current or prior whole body vibration.Active Control1 Intervention
Group III: Determine how lumbar disc fluid flow is acutely affected by whole body vibratiActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milwaukee VA Medical Center

Lead Sponsor

Trials
4
Recruited
390+

Medical College of Wisconsin

Collaborator

Trials
645
Recruited
1,180,000+

Indiana University

Collaborator

Trials
1,063
Recruited
1,182,000+

VA Office of Research and Development

Collaborator

Trials
1,691
Recruited
3,759,000+

Naval Aeromedical Research Unit, Dayton

Collaborator

Trials
1
Recruited
320+