Wearable Spine Health System for Military Readiness

The Ohio State University

Status

Enrolling

Conditions

Neck Pain

Low Back Pain

Study type

Observational

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05944354

2022X0054

Details and patient eligibility

About

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:

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).
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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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