Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
400 participants
OBSERVATIONAL
2022-09-23
2032-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Spine Phenome Project
NCT05776771
Post-market Study of the TOPS™ System
NCT02234154
Wallis Mechanical Normalization System for Low Back Pain
NCT00134537
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
NCT06355791
Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
NCT06126887
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Back Pain
Subjects with Low Back Pain
No interventions assigned to this group
Neck Pain
Subjects with Neck Pain
No interventions assigned to this group
Control
Subjects with healthy spines, who have no neck or low back pain
No interventions assigned to this group
Operational Air Crew
Subjects that are in training aircrew program
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Defense
FED
Ohio State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
William Marras
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Luke Air Force Base
Luke Air Force Base, Arizona, United States
Schriever Space Force Base
Colorado Springs, Colorado, United States
Peterson Space Force Base
Colorado Springs, Colorado, United States
Eglin Air Force Base
Eglin Air Force Base, Florida, United States
Uniformed Services University
Bethesda, Maryland, United States
Holloman Air Force Base
Holloman Air Force Base, New Mexico, United States
Seymour-Johnson Air Force Base
Seymour-Johnson Air Force Base, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Wright-Patterson Air Force Research Laboratory
Wright-Patterson Air Force Base, Ohio, United States
Joint Base Langley- Eustis Air Force Base
Langley Air Force Base, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Deborah Guthmann, DPT
Role: primary
Sean Batzer
Role: primary
Sean Batzer
Role: primary
Stephanie Chayrez
Role: primary
Alanna Solomon-Dodson
Role: primary
Andrew Smietana
Role: primary
Haley Gill, IOS
Role: primary
Molly Wade, MS, M.Ed
Role: primary
Ryan Scott
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022X0054
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.