Actively Recruiting
Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes
Led by Aclarion · Updated on 2026-04-15
300
Participants Needed
8
Research Sites
133 weeks
Total Duration
On this page
Sponsors
A
Aclarion
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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."
CONDITIONS
Official Title
Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years (inclusive) and skeletally mature (non-pregnant)
- Plans to undergo surgical treatment for discogenic back pain
- Treatment involves on-label use of FDA-cleared or FDA-approved devices
- Diagnosis of discogenic back pain at up to two lumbar levels caused by degenerative disc disease confirmed by MRI
- Preoperative Oswestry Disability Questionnaire score of at least 35 out of 100
- Visual Analog Scale (VAS) back pain score of at least 40mm and worse than leg pain score
- Failed at least 6 months of non-operative treatment or requires urgent surgery
- Signed informed consent form approved by IRB
- Psychosocially, mentally, and physically able and willing to comply with protocol and follow-up requirements
You will not qualify if you...
- Primary diagnosis of spinal condition other than degenerative disc disease at involved level
- Prior lumbar back surgery or intradiscal treatments at any lumbar level (excluding diagnostic discography and certain surgeries over 6 months ago)
- Planned surgery for more than 2 lumbar levels
- Severe spinal canal stenosis
- Motor strength deficits in lower extremities
- Radiographic lumbar vertebral abnormalities including spondylolisthesis Grade 2 or higher, pars fracture, spondylolysis, scoliosis with Cobb angle >15°, prior fracture or trauma to lumbar levels, lumbar kyphosis
- Radiologic evidence of uncontained lumbar disc herniation or extrusion
- Contraindication for standard lumbar MRI exam
- Pregnant or breastfeeding women during study scan periods
- Currently receiving worker's compensation or involved in litigation related to injury or medical issues
- Chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction affecting compliance
- Body mass index (BMI) greater than 40
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Todd H. Lanman, M.D Inc
Beverly Hills, California, United States, 90210
Actively Recruiting
2
Scripps Health
La Jolla, California, United States, 92037
Actively Recruiting
3
USC Keck Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Advocate Aurora Research Institute
Park Ridge, Illinois, United States, 60068
Actively Recruiting
7
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
Texas Back Institute
Plano, Texas, United States, 75093
Actively Recruiting
Research Team
R
Ryan Bond
CONTACT
A
Andy Murillo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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