Low Back Pain, Neck Pain
Conditions
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.
Interventions
None listed
Sponsors
Ohio State University
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motion Index | 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) | 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." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 | 2030 | The PROMIS-29 captures data from 7 domains ranging from Pain intensity, Pain Interference, Physical Function, Depression, Anixety, Fatigue, Sleep Disturbance, and Social Role |
| Pain Catastrophizing scale (PCS-6) | 2030 | PCS is used to characterize pain catastrophizing behaviors. It ranges between 0 - 24, with higher scores indicating more catastrophizing tendencies |
Countries
United States
Contacts
CONTACTLindsay Hanes, BS, CCRC
Outcome results
None listed