NCT05776771 · Ohio State University
The Spine Phenome Project
What this study is about
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.
View original scientific 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 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. 2. 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 and older
- Able to stand for 20 minutes
- Able to speak, read, and understand English
Exclusion criteria
- 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
- 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 Inclusion Criteria
- Age 18 and older
- Currently seeking medical consult with primary complaint of low back pain
- Able to speak, read, and understand English
- Able to stand for 10 minutes Exclusion criteria:
- 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 Inclusion Criteria
- 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 Exclusion criteria:
- 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
Where
- Columbus, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations