Wearable Spine Health System for Military Readiness

NCT05944354 | Enrolling By Invitation

• 1 other identifier: 2022X0054
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this observational trial is to compare the health history and motion capabilities of participants with low back pain disorders to participants with healthy spines. The main question\[s\] it aims to answer are to:

1. 1.Primary outcomes of this research effort include the development of composite measures or digital biomarkers to track functional recovery over time and predict duty or work status outcomes (return-to-full duty/work, limited duty/work restrictions or medical discharge/long-term disability).
2. 2.Secondary outcomes of this research effort include characterization of motion assessment utility to predict reinjury risk and evaluate intervention effectiveness. In addition, exploratively, the investigators will determine biopsychosocial profiles of low back pain, and neck pain military populations to identify low back and neck pain phenotypes.

Conditions

Low Back Pain; Neck Pain

Outcome Measures

Primary Outcomes (1)

• Predict Work Status

  To track functional recovery over time that can predict duty or work status.

  2030

Secondary Outcomes (1)

• Predict Reinjury Risk

  2030

Study Arms (4)

Low Back Pain

Subjects with Low Back Pain

Neck Pain

Subjects with Neck Pain

Control

Subjects with healthy spines, who have no neck or low back pain

Operational Air Crew

Subjects that are in training aircrew program

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

There are 4 different study populations: Control, Low Back Pain, Neck Pain, and Operational Air Crew

You may qualify if:

• Control Cohort
• Ages 18-64
• Able to stand for at least 25 minutes
• Able to speak, read, and understand English
• Low Back Pain Cohort
• Age 18-64
• Able to stand for at least 15 minutes
• Able to speak, read, and understand English
• Within the last 3 months, an episode of low back pain lasting longer than 7 days and/or seeing a health care provider for low back pain and/or on duty/work restriction due to low back pain.
• Neck Pain Cohort
• Ages 18-64
• Able to stand for at least 15 minutes
• Able to speak, read, and understand English
• Within the last 3 months, an episode of neck pain lasting longer than 7 days and/or seeing a health care provider for neck pain and/or on duty/work restriction due to neck pain.
• Operational Air crew Cohort

You may not qualify if:

• Control Cohort
• Known pregnancy
• Within the last 3 months, back or neck pain lasting longer than 7 days and/or seeing a health care provider for low back or neck pain and/or on duty/work restriction due to low back or neck pain.
• Actively being treated by a medical provider for concussion or traumatic brain injury
• Known severe spine curvature or deformity requiring medical treatment (e.g. scoliosis)
• Has been diagnosed by a medical provider with severe vertigo, fainting, narcolepsy, or balance disorders with high risk for falling
• Any known fractures within the last 3 months that will interfere with the motion assessment
• History of spine fracture
• Current condition requiring a bracing or immobilization of the spine
• History of spine surgery (e.g. fusion, micro-discectomy, or artificial disc replacement)
• History of brain or spine cancer
• Currently or within the last 90 days, been treated for cancer with chemotherapy or radiation therapy
• Known severe bone loss or osteoporosis requiring medical treatment and physician-recommended physical restrictions
• Current open wounds on the body where the harnesses will be placed on the neck, head, back, or hips
• Current osteomyelitis or spine infection

Sponsors & Collaborators

• Ohio State University: lead
• United States Department of Defense: collaborator

Study Sites (6)

Luke Air Force Base

Luke Air Force Base, Arizona, 85309, United States

Location

Holloman Air Force Base

Holloman Air Force Base, New Mexico, 88330, United States

Location

Seymour-Johnson Air Force Base

Seymour-Johnson Air Force Base, North Carolina, 27530, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Wright-Patterson Air Force Research Laboratory

Wright-Patterson Air Force Base, Ohio, 45433, United States

Location

Joint Base Langley- Eustis Air Force Base

Langley Air Force Base, Virginia, 23665, United States

Location

MeSH Terms

Conditions

Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: July 13, 2023
• Study Start: September 23, 2022
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (6)