NCT07367139

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

BiomechanicsMagnetic Resonance Imaging (MRI)Whole Body VibrationLumbar SpineDegenerationIntervertebral DiscHydrationOswestry Disability IndexPainDETECTPain CatastrophizingPROMISBrief Pain InventoryLongitudinalEndplate

Outcome Measures

Primary Outcomes (2)

  • Occupational Whole Body Vibration History

    We will use questionnaires to quantify each subject's history with regard to occupational whole body vibration. Groups will include subjects that had whole body vibration while in the military, subjects that have current occupations with whole body vibration, and subjects that have not significant history of whole body vibration.

    Whole body vibration questionnaires will be provided at the time of enrollment and immediately prior to each MRI scan.

  • Oswestry Disability Index

    Patient-reported outcome measure that assesses the degree to which low back pain impacts a person's daily functioning. The questionnaire consists of 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, traveling). Each section has 6 statements scored 0-5; patient selects the statement that best describes them.

    ODI will be collected at the time of enrollment and again immediately prior to each MRI scan.

Study Arms (3)

Longitudinal effects of current or prior whole body vibration.

NO INTERVENTION

Determine the impact of acute and longitudinal WBV on lumbar spine endplate health. The objective is to perform a repeated measures study using multi-parametric MRI to assess Veteran endplate health. Veterans will participate in pain assessments and MRI scans annually for three years to track the progression of whole body vibration-related changes in the lumbar spine endplates and intervertebral discs. Current and prior whole body vibration characteristics will be correlated to pain scores and MRI changes.

Determine how lumbar disc fluid flow is acutely affected by whole body vibrati

NO INTERVENTION

The objective is to perform a repeated measures study to quantify changes in lumbar spine T2 relaxation times and volumetric MRI data following acute experimental vibrational exposure to determine fluid transport patterns and morphological changes. Veterans will participate in pain questionnaires, and receive Upright MRI scans prior to and immediately following 30 minutes of low magnitude whole body vibration. This unique protocol will allow us to assess acute changes in MR metrics and structural dimensions of the lumbar spine following exposure to WBV by comparing measurements obtained immediately following experimental WBV to pre-WBV measurements.

Effect of hydration on lumbar spine response to whole body vibration

EXPERIMENTAL

This arm will determine whether individual hydration state influences IVD water dynamics following acute vibrational exposure. The objective is to assess the impact of hydration on IVD fluid distribution and transport in response to acute vibration utilizing multi-parametric MRI analysis. This will allow for evaluation of hydration as a potential factor for rehabilitation, treatment, and prevention of early degeneration related to WBV. MRI scans will be obtained under two conditions: hydrated and dehydrated. For the hydrated MRI scans, research subjects will be asked to consume a minimum of 2.7 liters of fluid per day for three days leading up the MRI date. For the dehydrated MRI scans, research subjects will be asked to consume about 1.3 liters of fluid per day for three days leading up to the MRI date. WBV induced changes to IVD water dynamics will be compared within subjects for the hydration, dehydration and control conditions.

Other: Water

Interventions

WaterOTHER

Aim 3 will evaluate the effect of hydration and dehydration on acute whole body vibration response of the lumbar spine endplate and intervertebral disc.

Effect of hydration on lumbar spine response to whole body vibration

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking; Male/Female Veterans age 20-45 years; BMI \< 30; ability to sit upright for 60 mins; ability to drive to Deerfield, IL; ambulatory

You may not qualify if:

  • Previous spinal surgery; conditions/diseases associated with altered pain perception including neurological diseases (e.g., multiple sclerosis, trigeminal neuralgia, central sensitization), major psychiatric disorders, diabetes, neoplasm and cardiovascular disorders, chronic widespread pain diagnosis, pregnant women, MRI contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zablocki Veterans Affairs Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

MeSH Terms

Conditions

Disease

Interventions

Water

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Brian D Stemper, PhD

    Milwaukee VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Veenendaal, RN

CONTACT

Alok Shah, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Health Scientist

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Written requests for IPD must be made directly to the study PI. The request must include a description of the specific data being requested, the purpose for the request, anticipated outcomes from usage of IPD, and a statement that the study and PI will be acknowledged in any publications resulting from use of IPD. The Investigative Team will evaluate any requests and will decide to share or not share IPD. Only de-identified data will be provided.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The Study Team will review requests for IPD following the first year of the study and will continue reviewing requests indefinitely.
Access Criteria
The Study Team will evaluate each request individually and decide on the type and format of data that will be shared.

Locations