Wearable Spine Health System for Military Readiness

Last updated: January 22, 2024
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neck Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT05944354
2022X0054
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study 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. 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. 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.

Participants will complete questionnaires and wear a motion monitor that will assess the participant's back and/or neck. This session will be approximately 40-70 minutes. The research team will follow up with participants at 3 month, 6 months, and 1 year to complete a short series of questionnaires and a motion assessment test.

Eligibility Criteria

Inclusion

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 daysand/or seeing a health care provider for low back pain and/or on duty/work restrictiondue 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/orseeing a health care provider for neck pain and/or on duty/work restriction due toneck 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 ofstandard operations

Exclusion

Exclusion Criteria: Control Cohort

  • Known pregnancy
  • Within the last 3 months, back or neck pain lasting longer than 7 days and/or seeing ahealth care provider for low back or neck pain and/or on duty/work restriction due tolow 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, orbalance disorders with high risk for falling
  • Any known fractures within the last 3 months that will interfere with the motionassessment
  • 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 discreplacement)
  • History of brain or spine cancer
  • Currently or within the last 90 days, been treated for cancer with chemotherapy orradiation therapy
  • Known severe bone loss or osteoporosis requiring medical treatment andphysician-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 itis 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.) thatoccurred 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, orbalance disorders with high risk for falling
  • Any known fractures within the last 3 months that will interfere with the motionassessment
  • 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 orradiation therapy
  • Known severe bone loss or osteoporosis requiring medical treatment andphysician-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 itis unsafe for participant to perform test Neck Pain Cohort
  • Known pregnancy
  • Current neck pain is the result of a traumatic injury (wreck, fall, etc.) thatoccurred 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, orbalance disorders with high risk for falling
  • Any known fractures within the last 3 months that will interfere with the motionassessment
  • 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 orradiation therapy
  • Known severe bone loss or osteoporosis requiring medical treatment andphysician-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 itis 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 withimaging
  • 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, orbalance disorders with high risk for falling
  • Any known fractures within the last 3 months that will interfere with the motionassessment
  • 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 orradiation therapy
  • Known severe bone loss or osteoporosis requiring medical treatment andphysician-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 itis unsafe for participant to perform test

Study Design

Total Participants: 400
Study Start date:
September 23, 2022
Estimated Completion Date:
December 31, 2032

Connect with a study center

  • Luke Air Force Base

    Luke Air Force Base, Arizona 85309
    United States

    Site Not Available

  • Peterson Space Force Base

    Colorado Springs, Colorado 80914
    United States

    Site Not Available

  • Schriever Space Force Base

    Colorado Springs, Colorado 80912
    United States

    Site Not Available

  • Eglin Air Force Base

    Eglin Air Force Base, Florida 32542
    United States

    Active - Recruiting

  • Uniformed Services University

    Bethesda, Maryland 20814
    United States

    Active - Recruiting

  • Holloman Air Force Base

    Holloman Air Force Base, New Mexico 88330
    United States

    Site Not Available

  • Seymour-Johnson Air Force Base

    Seymour Johnson Air Force Base, North Carolina 27530
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Wright-Patterson Air Force Research Laboratory

    Wright-Patterson Air Force Base, Ohio 45433
    United States

    Active - Recruiting

  • Joint Base Langley- Eustis Air Force Base

    Langley Air Force Base, Virginia 23665
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.