Clinical trial NCT05944354: Wearable Spine Health System for Military Readiness
Official title: Wearable Spine Health System for Military Readiness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Neck Pain
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-07-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are 4 different study populations: Control, Low Back Pain, Neck Pain, and Operational Air Crew

Brief 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 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

Primary outcomes:
measure: Predict Work Status
timeFrame: 2030
Secondary outcomes:
measure: Predict Reinjury Risk
timeFrame: 2030
Other outcomes:
Locations:
city: Luke Air Force Base
country: United States
facility: Luke Air Force Base
state: Arizona
city: Colorado Springs
country: United States
facility: Schriever Space Force Base
state: Colorado
city: Colorado Springs
country: United States
facility: Peterson Space Force Base
state: Colorado
city: Eglin Air Force Base
country: United States
facility: Eglin Air Force Base
state: Florida
city: Bethesda
country: United States
facility: Uniformed Services University
state: Maryland
city: Holloman Air Force Base
country: United States
facility: Holloman Air Force Base
state: New Mexico
city: Seymour Johnson Air Force Base
country: United States
facility: Seymour-Johnson Air Force Base
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Wright-Patterson Air Force Base
country: United States
facility: Wright-Patterson Air Force Research Laboratory
state: Ohio
city: Langley Air Force Base
country: United States
facility: Joint Base Langley- Eustis Air Force Base
state: Virginia
Study officials:
References: