RECRUITING

Wearable Spine Health System for Military Readiness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Wearable Spine Health System for Military Readiness

Quick Facts

Study Start:2022-09-23

Study Completion:2032-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05944354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Ages 18-64 * Able to stand for at least 25 minutes * Able to speak, read, and understand English * 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. * 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. * 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	* 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 * 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 * 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 * 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

Inclusion Criteria

Exclusion Criteria

* Ages 18-64
* Able to stand for at least 25 minutes
* Able to speak, read, and understand English
* 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.
* 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.
* 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

* 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
* 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
* 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
* 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

Contacts and Locations

Study Contact

Lindsay Hanes, BS, CCRC

CONTACT

614-257-2294

lindsay.hanes@osumc.edu

Study Locations (Sites)

Luke Air Force Base

Luke Air Force Base, Arizona, 85309

United States

Schriever Space Force Base

Colorado Springs, Colorado, 80912

United States

Peterson Space Force Base

Colorado Springs, Colorado, 80914

United States

Eglin Air Force Base

Eglin Air Force Base, Florida, 32542

United States

Uniformed Services University

Bethesda, Maryland, 20814

United States

Holloman Air Force Base

Holloman Air Force Base, New Mexico, 88330

United States

Seymour-Johnson Air Force Base

Seymour Johnson Air Force Base, North Carolina, 27530

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Wright-Patterson Air Force Research Laboratory

Wright-Patterson Air Force Base, Ohio, 45433

United States

Joint Base Langley- Eustis Air Force Base

Langley Air Force Base, Virginia, 23665

United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-23

Study Completion Date2032-12-31

Study Record Updates

Study Start Date2022-09-23

Study Completion Date2032-12-31

Terms related to this study

Additional Relevant MeSH Terms

Low Back Pain
Neck Pain