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Search / Trial NCT05944354

Wearable Spine Health System for Military Readiness

Launched by OHIO STATE UNIVERSITY · Jul 5, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called the Wearable Spine Health System for Military Readiness, is studying how low back pain and neck pain affect military personnel compared to those with healthy spines. The main goal is to develop tools that track recovery over time and help predict whether someone can return to full duty, have work restrictions, or may need long-term medical support. Researchers will also look into how movement patterns can indicate the risk of reinjury and evaluate the effectiveness of treatments.

Participants who are between 18 and 64 years old and either have low back or neck pain, or are healthy, may be eligible for the study. Those with specific conditions, like severe spine issues or recent injuries, may not qualify. If you join the study, you'll wear a motion monitor and complete some questionnaires during a session that lasts about 40-70 minutes. The research team will follow up with you at 3 months, 6 months, and 1 year to check in on your progress and gather more information. This research aims to better understand these common pain issues in military settings and improve care for those affected.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Ages 18-55
  • Able to stand for at least 25 minutes
  • Able to speak, read, and understand English
  • Ability to participate in cervical and back endurance training programs as part of standard operations
  • Exclusion Criteria:
  • 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
  • Any other reason that a treating physician, researcher, or participant determines it is unsafe for a patient to perform test
  • Low Back Pain Cohort
  • Known pregnancy
  • Current low back pain is the result of a traumatic injury (wreck, fall, etc.) that occurred within the last 3 months OR is positive for spine instability with imaging
  • Has spinal fusion across 4 or more lumbar disc levels
  • Currently 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
  • Any known spinal instability or spine fractures within the last 6 months
  • Current condition requiring a bracing or immobilization of the spine
  • 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 back or hips
  • Current spine infection or osteomyelitis
  • Any other reason that a treating physician, researcher, or participant determines it is unsafe for participant to perform test
  • Neck Pain Cohort
  • Known pregnancy
  • Current neck pain is the result of a traumatic injury (wreck, fall, etc.) that occurred within the last 3 months OR is positive for spine instability with imaging
  • Has spinal fusion across 4 or more cervical disc levels
  • Has an occipital-cervical fusion
  • Currently 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
  • Any known spinal instability or spine fractures within the last 6 months
  • Current condition requiring a bracing or immobilization of the spine
  • 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 or head
  • Current spine infection or osteomyelitis
  • Any other reason that a treating physician, researcher, or participant determines it is unsafe for participant to perform test
  • Operational Air crew Cohort
  • Known pregnancy
  • Current neck and/or low back pain is the result of a traumatic injury (wreck, fall, etc.) that occurred within the last 3 months OR is positive for spine instability with imaging
  • Has spinal fusion across 4 or more lumbar disc levels
  • Currently 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
  • Any known spinal instability or spine fractures within the last 6 months
  • Current condition requiring a bracing or immobilization of the spine
  • 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 back or hips
  • Current spine infection or osteomyelitis
  • Any other reason that a treating physician, researcher, or participant determines it is unsafe for participant to perform test

About Ohio State University

The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.

Locations

Columbus, Ohio, United States

Bethesda, Maryland, United States

Eglin Air Force Base, Florida, United States

Luke Air Force Base, Arizona, United States

Colorado Springs, Colorado, United States

Colorado Springs, Colorado, United States

Holloman Air Force Base, New Mexico, United States

Seymour Johnson Air Force Base, North Carolina, United States

Wright Patterson Air Force Base, Ohio, United States

Langley Air Force Base, Virginia, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported