This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."
Study Type
OBSERVATIONAL
Enrollment
300
The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Todd H. Lanman, M.D Inc
Beverly Hills, California, United States
RECRUITINGScripps Health
La Jolla, California, United States
RECRUITINGUSC Keck Medical Center
Los Angeles, California, United States
Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline. VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.
Time frame: Baseline to 12 months
20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.
Time frame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment
VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.
Time frame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Patient reported treatment satisfaction survey
Patient Satisfaction survey is a self-reported questionnaire to measure the subject's satisfaction of the treatment under the protocol.
Time frame: Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Patient-Reported Outcome Measurement Information System (PROMIS) 29 score
The PROMIS-29 v2. 0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Miami
Miami, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGAdvocate Aurora Research Institute
Park Ridge, Illinois, United States
RECRUITINGJohns Hopkins Medicine
Baltimore, Maryland, United States
RECRUITINGTexas Back Institute
Plano, Texas, United States
RECRUITINGTime frame: Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Cumulative proportion of responders (CPRA) for 15 point Oswestry Disability Index (ODI) change (out of 100)
The Oswestry Disability Index (ODI) is a 10-item questionnaire that scores disability on a percentile scale from 0-100%. The ODI score is interpreted as follows: 0-20%: Minimal disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Crippling effects 80-100%: Completely disabled and bedbound
Time frame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Absence of Secondary surgical intervention
Secondary surgical interventions may include revision, reoperation, removal or supplemental fixation at any level in the lumbar spine.
Time frame: From Baseline through study completion, 24-Months
Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores
VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.
Time frame: From Baseline through study completion, 24-Months