Aclarion
This study is looking into how useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan 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.
Inclusion Criteria: 1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive); 2. Subject intends to undergo instrumented surgical treatment in the lumbar spinal disc for their lower back pain, independent of this research protocol; 3. Subject is to be treated with FDA-cleared or FDA-approved devices independent of this research protocol; 4. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100); 5. Subject has a VAS back pain score of ≥40mm; 6. Subject has failed at least ≥ 6 months of non-operative treatment (f…
The surgical treatment will be decided by the treating investigator based on their clinical judgement.