Image

Wearable Spine Health System for Military Readiness

Wearable Spine Health System for Military Readiness

Recruiting
18-64 years
All
Phase N/A

Powered by AI

Overview

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

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

Study details
    Low Back Pain
    Neck Pain

NCT05944354

Ohio State University

29 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.