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RECRUITING

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain

NCT06661850•Aclarion

View on ClinicalTrials.gov

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

18 - 70 years

Sex

ALL

Healthy Volunteers

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 100 points (35/100);
•6. Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
•7. 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;
•8. Subject has signed the IRB approved Informed Consent Form; and
•9. 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 a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
•2. 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);
•3. Surgery is planned for more than 2 lumbar levels.
•4. Subject has severe spinal canal stenosis as assessed by the Investigator;
•5. Subject has a motor strength deficit(s) in lower extremities
•6. 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:
•* Spondylolisthesis Grade 2 or greater (up to Grade 1 is accepted)
•* Pars fracture, at the involved level
•* Spondylolysis
•* Lumbar scoliosis with a Cobb angle of greater than 15°
+8 more criteria

Locations (7)

Scripps Health

La Jolla, California, United States

USC Keck Medical Center

Los Angeles, California, United States

University of Miami

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

Advocate Aurora Research Institute

Park Ridge, Illinois, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

Texas Back Institute

Plano, Texas, United States

Key Dates

Start Date

June 11, 2025

Primary Completion Date

September 30, 2027

Completion Date

December 31, 2027

Last Updated

March 9, 2026

Enrollment

300

ESTIMATED participants

Conditions

Discogenic Low Back Pain

Interventions

Fusion or TDR determined by investigator.

PROCEDURE

Contacts

Ryan Bond

CONTACT

724-991-3369 rbond@aclarion.com

Andy Murillo

CONTACT

amurillo@aclarion.com

A Comparative Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine

NCT03716947

Degenerative Disc DiseaseDiscogenic Low Back Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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