NCT05944354招募中不适用
Wearable Spine Health System for Military Readiness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Predict Work Status
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- 另有 15 项未显示
结局指标
主要结局
Predict Work Status
时间窗: 2030
To track functional recovery over time that can predict duty or work status.
次要结局
- Predict Reinjury Risk(2030)
研究者
William Marras
Principal Investigator
Ohio State University
研究点 (10)
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