Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes
ConditionDiscogenic Low Back Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAclarion
About this trial
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 criteria
Qualifiers
Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
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);
Disqualifiers
Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
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);
Surgery is planned for more than 2 lumbar levels.
Subject has severe spinal canal stenosis as assessed by the Investigator;
Trial design
Treatments tested in this trial
- Fusion or TDR determined by investigator.
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Aclarion
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov