Recruiting
Observational
Examination of Nociscan Impact on Low Back Pain Surgical Outcomes
Condition(s) studied
Low Back Pain
Investigational drug(s) / intervention(s)
Fusion or TDR determined by investigator.
Fusion or TDR determined by investigator.: The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Study summary
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.
Eligibility
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 (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator;
7. Subject has signed the IRB approved Informed Consent Form; and
8. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Exclusion Criteria:
1. Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);
2. Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including:
* Grade 3 Spondylolisthesis (Grade 1 or Grade 2 is allowed)
* Pars fracture, at the involved level
* Spondylolysis
* Lumbar scoliosis with a Cobb angle of greater than 20°
* Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst
* Lumbar kyphosis
3. Subject is contraindicated for a standard lumbar MRI exam
4. Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed
5. Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and/or may confound data
Primary outcome measure(s)
- Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment — Baseline to 12 months
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.
Trial sites (10)
| Facility | City | Region | Status |
| University of Arizona |
Phoenix |
Arizona |
Recruiting |
| Todd H. Lanman, M.D Inc |
Beverly Hills |
California |
Recruiting |
| Scripps Health |
La Jolla |
California |
Recruiting |
| USC Keck Medical Center |
Los Angeles |
California |
Recruiting |
| University of Miami/ Jackson Health System |
Miami |
Florida |
Recruiting |
| Northwestern University |
Chicago |
Illinois |
Recruiting |
| Endeavor Health |
Evanston |
Illinois |
Recruiting |
| Advocate Aurora Research Institute |
Park Ridge |
Illinois |
Recruiting |
| Johns Hopkins Medicine |
Baltimore |
Maryland |
Recruiting |
| Texas Back Institute |
Plano |
Texas |
Recruiting |
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