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Enrolling by Invitation

NCT Number: NCT05944354

Wearable Spine Health System for Military Readiness

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.

Enrolling by Invitation

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Key information

Conditions

Low Back Pain Back Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Luke Air Force Base, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Predict Work Status

    Time frame: 2030

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

Secondary outcomes

  1. Predict Reinjury Risk

    Time frame: 2030

    To track reinjury risk and evaluate intervention effectiveness to predict reinjury risk.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jul 13, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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