Low Back PainNCT05776771
The Spine Phenome Project
An observational study of Low Back Pain and Neck Pain, run by Ohio State University at 1 site 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Neck Pain
- How many people
- 10,500 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 31 Dec 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: There are 3 different study populations: Controls/Insincere, Low Back Pain, and Neck Pain
Who may be able to join
- Age 18 and older
- Able to stand for 20 minutes
- Able to speak, read, and understand English
- Age 18 and older
- Currently seeking medical consult with primary complaint of low back pain
- Able to speak, read, and understand English
Show all 11Show fewer
- Able to stand for 10 minutes
- Age 18 and older
- Currently seeking medical consult with primary complaint of neck pain
- Able to speak, read, and understand English
- Able to stand for 10 minutes
Who cannot join
- Known pregnancy
- Currently seeing or planning to see a medical provider for low back or neck pain
- History of chronic low back or neck pain lasting longer than 3 months
- Blind or severe uncorrected vision problems that prevent participant from reading a tablet or laptop screen
- Deaf or hearing problems that prevent the participant from hearing verbal instructions
- Actively being treated by a medical provider for concussion
Show all 56Show fewer
- Known severe spinal 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 immobilization or bracing 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 osteoporosis requiring medical treatment and physician-recommended physical restrictions
- Current open wounds or medical device entry points where the harnesses will be placed on the neck, 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 Patients
- Known pregnancy
- Blind or severe uncorrected vision problems that prevent participant from reading a tablet or laptop screen
- Deaf or hearing problems that prevent the participant from hearing verbal instructions
- 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.
- Actively being treated by a medical provider for concussion
- Known severe spinal 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 spine fractures within the last 6 months
- Known unstable spondylolisthesis (i.e. standing 3mm of movement on flexion/extension film)
- Current condition requiring immobilization of the spine
- History of brain or spine cancer
- Currently or within the last 90 days, been treated for any cancer with chemotherapy or radiation therapy
- Known severe osteoporosis requiring medical treatment and physician-recommended physical restrictions
- Current open wounds or medical device entry points where the harnesses will be placed on the 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
- Neck Pain Patients
- Known pregnancy
- Blind or severe uncorrected vision problems that prevent participant from reading a tablet or laptop screen
- Deaf or hearing problems that prevent the participant from hearing verbal instructions
- 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 or an occipital-cervical fusion.
- Actively being treated by a medical provider for concussion
- Known severe spinal 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 spine fractures within the last 6 months
- Known unstable spondylolisthesis (i.e. standing 3mm of movement on flexion/extension film)
- Current condition requiring immobilization of the spine
- History of brain or spine cancer
- Currently or within the last 90 days, been treated for any cancer with chemotherapy or radiation therapy
- Known severe osteoporosis requiring medical treatment and physician-recommended physical restrictions
- Current open wounds or medical device entry points where the harnesses will be placed on the neck or back
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Lindsay Hanes, BS, CCRC, 614-257-2294, lindsay.hanes@osumc.edu
William Marras, PhD, CPE
About this study
Official title: The Spine Phenome Project: Enabling Technology for Personalized Medicine
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 composite measures that differentiate between control and patient populations, predict injury or reinjury risk, identify low back and neck pain patient phenotypes, and evaluate treatment effectiveness.
- Secondary outcomes of this research effort include an assessment of wearable motion sensor accuracy, characterization of motion assessment utility, biopsychosocial profiling of control and low back and neck pain patient populations, and differentiation of sincere and insincere motion assessment efforts.
Participants will complete questionnaires and wear a motion monitor that will assess your 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, 1 year, 2 years, 5 years 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/Insincere | Subjects with healthy spines, who have no neck or low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion Index
Composite functional score ranging from 0 - 100, with higher scores indicating healthier function. This is a composite metric derived from a standardized sensor-enabled spinal motion assessment. Motion features extracted from the motion assessment are benchmarked against a normative population.
Measured: 2030
Patient's Global Impression of Change (PGIC)
PGIC is a 7 point scale indicating a patient's preception of overall improvement after treatment. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: 2030
Secondary outcomes (2)
PROMIS-29
The PROMIS-29 captures data from 7 domains ranging from Pain intensity, Pain Interference, Physical Function, Depression, Anixety, Fatigue, Sleep Disturbance, and Social Role
Measured: 2030
Pain Catastrophizing scale (PCS-6)
PCS is used to characterize pain catastrophizing behaviors. It ranges between 0 - 24, with higher scores indicating more catastrophizing tendencies
Measured: 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start18 Dec 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 10,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, William Marras, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776771
- Sponsor's protocol ID
- 2020H0250
- Other IDs
- 4UH3AR076729-02
- 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
Publications
Mageswaran P, Dufour J, Aurand A, Knapik G, Hani H, Blakaj DM, Khan S, Hussain N, Tiwari M, Vallabh J, Weaver T, Marras WS. Wearable motion-based platform for functional spine health assessment. Reg Anesth Pain Med. 2024 Jul 8;49(7):518-527. doi: 10.1136/rapm-2023-104840.
PubMed 37813527
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
- The Spine Phenome Project: Enabling Technology for Personalized Medicine
- ClinicalTrials.gov ID
- NCT05776771
- Acronym / sponsor ID
- 2020H0250
- Conditions
- Low Back Pain, Neck Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,500 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 20 Mar 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 composite measures that differentiate between control and patient populations, predict injury or reinjury risk, identify low back and neck pain patient phenotypes, and evaluate treatment effectiveness.
- Secondary outcomes of this research effort include an assessment of wearable motion sensor accuracy, characterization of motion assessment utility, biopsychosocial profiling of control and low back and neck pain patient populations, and differentiation of sincere and insincere motion assessment efforts.
Participants will complete questionnaires and wear a motion monitor that will assess your 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, 1 year, 2 years, 5 years to complete a short series of questionnaires and a motion assessment test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain | – | –Subjects with Low Back Pain |
| Neck Pain | – | –Subjects with Neck Pain |
| Control/Insincere | – | –Subjects with healthy spines, who have no neck or low back pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There are 3 different study populations: Controls/Insincere, Low Back Pain, and Neck Pain
Key inclusion criteria (11 listed)
- Age 18 and older
- Able to stand for 20 minutes
- Able to speak, read, and understand English
- Age 18 and older
- Currently seeking medical consult with primary complaint of low back pain
Key exclusion criteria (56 listed)
- Known pregnancy
- Currently seeing or planning to see a medical provider for low back or neck pain
- History of chronic low back or neck pain lasting longer than 3 months
- Blind or severe uncorrected vision problems that prevent participant from reading a tablet or laptop screen
- Deaf or hearing problems that prevent the participant from hearing verbal instructions
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
Motion Index
Time frame: 2030
Composite functional score ranging from 0 - 100, with higher scores indicating healthier function. This is a composite metric derived from a standardized sensor-enabled spinal motion assessment. Motion features extracted from the motion assessment are benchmarked against a normative population.
Patient's Global Impression of Change (PGIC)
Time frame: 2030
PGIC is a 7 point scale indicating a patient's preception of overall improvement after treatment. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
2 secondary outcomes
PROMIS-29
Time frame: 2030
Pain Catastrophizing scale (PCS-6)
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.
- Derived from this study: PubMed 37813527Mageswaran P, Dufour J, Aurand A, Knapik G, Hani H, Blakaj DM, Khan S, Hussain N, Tiwari M, Vallabh J, Weaver T, Marras WS. Wearable motion-based platform for functional spine health assessment. Reg Anesth Pain Med. 2024 Jul 8;49(7):518-527. doi: 10.1136/rapm-2023-104840.
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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.
1 site 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 1 site 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 11 inclusion and 56 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: looking for participants now, 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 1 site 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?
Contact Lindsay Hanes, BS, CCRC (614-257-2294, lindsay.hanes@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion Index (time frame: 2030). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05776771, which also lists 1 linked publication.
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.