Clinical trial NCT05776771: The Spine Phenome Project
Official title: The Spine Phenome Project: Enabling Technology for Personalized Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Neck Pain
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-03-20
Enrollment: 10500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are 3 different study populations: Controls/Insincere, Low Back Pain, and Neck Pain

Brief 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. 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.


Eligibility criteria: Controls/Insincere

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

Primary outcomes:
measure: Motion Index
timeFrame: 2030
measure: Patient's Global Impression of Change (PGIC)
timeFrame: 2030
Secondary outcomes:
measure: PROMIS-29
timeFrame: 2030
measure: Pain Catastrophizing scale (PCS-6)
timeFrame: 2030
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: