Wearable technology for monitoring spine health in military personnel

Wearable Spine Health System for Military Readiness

This study is testing how wearable technology can help track spine health and recovery in military personnel with back and neck pain compared to those without these issues.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 10 sites (Luke Air Force Base, Arizona and 9 other locations)
• Trial ID: NCT05944354 on ClinicalTrials.gov

What this trial studies

This observational trial aims to compare the health history and motion capabilities of military personnel with low back and neck pain to those with healthy spines. Participants will wear a motion monitor and complete questionnaires to assess their conditions. The study focuses on developing digital biomarkers to track recovery and predict work status outcomes, as well as evaluating the risk of reinjury and the effectiveness of interventions. Additionally, it seeks to characterize the biopsychosocial profiles of military populations suffering from these conditions.

Who should consider this trial

Good fit: Ideal candidates include military personnel aged 18-64 with a recent history of low back or neck pain, as well as healthy controls.

Not a fit: Patients with chronic spine issues not related to recent episodes of low back or neck pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and management of spine health in military personnel, enhancing their readiness and reducing disability rates.

How similar studies have performed: Other studies have shown promise in using wearable technology for monitoring health outcomes, suggesting potential success for this approach.

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

Where this trial is running

Luke Air Force Base, Arizona and 9 other locations

• Luke Air Force Base — Luke Air Force Base, Arizona, United States (Not_yet_recruiting)
• Schriever Space Force Base — Colorado Springs, Colorado, United States (Not_yet_recruiting)
• Peterson Space Force Base — Colorado Springs, Colorado, United States (Not_yet_recruiting)
• Eglin Air Force Base — Eglin Air Force Base, Florida, United States (Recruiting)
• Uniformed Services University — Bethesda, Maryland, United States (Recruiting)
• Holloman Air Force Base — Holloman Air Force Base, New Mexico, United States (Not_yet_recruiting)
• Seymour-Johnson Air Force Base — Seymour Johnson Air Force Base, North Carolina, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• Wright-Patterson Air Force Research Laboratory — Wright-Patterson Air Force Base, Ohio, United States (Recruiting)
• Joint Base Langley- Eustis Air Force Base — Langley Air Force Base, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Lindsay Hanes, BS, CCRC

Conditions Low Back Pain; Neck Pain