A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain
Aclarion
Summary
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."
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive); 2. Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol; 3. Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol; 4. Subject has a diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI); 5. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 1…
Interventions
- ProcedureFusion or TDR determined by investigator.
The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Locations (8)
- Todd H. Lanman, M.D IncBeverly Hills, California
- Scripps HealthLa Jolla, California
- USC Keck Medical CenterLos Angeles, California
- University of MiamiMiami, Florida
- Northwestern UniversityChicago, Illinois
- Advocate Aurora Research InstitutePark Ridge, Illinois