Low Back PainNCT05944354
Wearable Spine Health System for Military Readiness
An observational study of Low Back Pain and Neck Pain, run by Ohio State University at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Neck Pain
- How many people
- 400 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Sep 2022to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: There are 4 different study populations: Control, Low Back Pain, Neck Pain, and Operational Air Crew
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
The Ohio State University
Columbus, Ohio, 43210
Holloman Air Force Base
Holloman Air Force Base, New Mexico, 88330
Joint Base Langley- Eustis Air Force Base
Langley Air Force Base, Virginia, 23665
Luke Air Force Base
Luke Air Force Base, Arizona, 85309
Seymour-Johnson Air Force Base
Seymour-Johnson Air Force Base, North Carolina, 27530
Wright-Patterson Air Force Research Laboratory
Wright-Patterson Air Force Base, Ohio, 45433
About this study
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.
- Conditions
- Low Back Pain, Neck Pain
- Medical subject headings
- Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain | Subjects with Low Back Pain | |
| Neck Pain | Subjects with Neck Pain | |
| Control | Subjects with healthy spines, who have no neck or low back pain | |
| Operational Air Crew | Subjects that are in training aircrew program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predict Work Status
To track functional recovery over time that can predict duty or work status.
Measured: 2030
Secondary outcomes (1)
Predict Reinjury Risk
To track reinjury risk and evaluate intervention effectiveness to predict reinjury risk.
Measured: 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start23 Sep 2022
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, William Marras, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944354
- Sponsor's protocol ID
- 2022X0054
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Spine Health System for Military Readiness
- ClinicalTrials.gov ID
- NCT05944354
- Acronym / sponsor ID
- 2022X0054
- Conditions
- Low Back Pain, Neck Pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain | – | –Subjects with Low Back Pain |
| Neck Pain | – | –Subjects with Neck Pain |
| Control | – | –Subjects with healthy spines, who have no neck or low back pain |
| Operational Air Crew | – | –Subjects that are in training aircrew program |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- There are 4 different study populations: Control, Low Back Pain, Neck Pain, and Operational Air Crew
Key inclusion criteria (19 listed)
- Control Cohort
- Ages 18-64
- Able to stand for at least 25 minutes
- Able to speak, read, and understand English
- Low Back Pain Cohort
Key exclusion criteria (65 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predict Work Status
Time frame: 2030
To track functional recovery over time that can predict duty or work status.
1 secondary outcome
Predict Reinjury Risk
Time frame: 2030
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Neck Pain, run by Ohio State University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 65 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predict Work Status (time frame: 2030). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.