Back pain can be caused by a large number of injuries or abnormal underlying medical conditions, thus making a proper diagnosis both difficult and critical. Low back pain (LBP) is classified into one of three categories, based on a description of how the pain is distributed throughout the body: axial LBP (also known as mechanical or simple back pain); radicular LBP (compression of a nerve exiting the spine adjacent to discs, characterized by radiating pain down the thighs and legs & typically presented as “sciatica”); and LBP with referred pain (axial pain also emanating to other parts of the body, and may share similar causes to axial LBP).
Axial LBP is the most common type of LBP, and is confined to the lower back area and does not predominantly radiate into the surrounding portions of the body. Axial LBP may arise from one or more different underlying causes, such as damage to the muscles, ligaments or tendons, or the intervertebral discs themselves – such as may be associated with degenerative disc disease (DDD) or “disc degeneration”, also called “discogenic” LBP. Most cases of axial LBP that are refractory (do not resolve) to extended conservative care are typically believed to be discogenic pain. Per varying potential causes, and pain sensation that is non-specific to finely isolated locations or related structures, diagnosis of axial LBP to the level of identifying the painful source discs causing the pain is generally very difficult – and conventional diagnostic approaches are “challenged” at best.
Provocative Discography: The patient provides a pain level after a needle is inserted into a lumbar disc and pressurized, and the injection site becomes potential disc failure point
Selective Nerve Blocks: Needles are injected into a spinal nerve, sacroiliac joint, facet and medial joints to isolate the pain source
Nocimed harnesses the existing power of Magnetic Resonance Spectroscopy (MRS) for non-invasive, objective quantification of relative chemical differences in tissues – but specifically applied to assess the relative chemical biomarkers for tissue degeneration and pain.
Our focus is to compare relative differences in these degenerative pain biomarkers between lumbar discs in patients receiving MRS exams of those tissues. This new information is intended to help doctors, in combination with other available diagnostic information, better diagnose disc pathologies along the lumbar spine. Examples of the potential utility of this new information include helping doctors to: assess the relative structural matrix integrity of disc nuclei that may be associated with degenerative disc disease (DDD); and diagnose painful discs that may be a cause of chronic, severe “discogenic” low back pain.
NOCIMED generates this new information merely via a patented post-processor engine that post-processes data acquired via leading commercial high field MR scanners and spectroscopy pulse sequences.
By providing this new information, NOCIMED is being positioned as a partner with Radiologists and MR Imaging Centers to enhance the value of lumbar MRI+MRS exams for low back pain patients and their referring doctors. NOCISCAN™ is an investigational technology platform being developed with the hopes to provide, in the future, a non-invasive, pain-free, objective diagnostic test that may assist in the diagnosis of lumbar disc pain based on a derivative of Magnetic Resonance Imaging (MRI) called Magnetic Resonance Spectroscopy (MRS).
MRS uses pulsed magnetic fields generated by an MR Scanner that cause chemical bonds in body tissues to vibrate, which generates signals that are detected by “antennae” detector coils placed along the spine. Certain chemicals vibrate at unique “signature” frequencies along a frequency “spectrum.” The level of detected signal at a given signature frequency for a chemical can be processed to measure the amount of that chemical in the tissue being examined.
A three-dimensional volume is defined in the disc nucleus and “vibrated” by the MR scanner using existing MRS pulse sequences via proprietary Nociscan™ protocol specific to discs.
Signals acquired from the nucleus are processed by Nociscan™ post-processing software to create MRS spectra. Spectral signatures are then measured as inputs to a diagnostic algorithm to generate a “Nociscore” correlated in clinical investigation studies to pain (as indicated by discography).
This report may assist a doctor, in combination with other available patent data, in diagnosing disc conditions, such as discogenic pain and/or degenerative disc disease.
NOCISCAN™ is being developed as an investigational software suite to work in the future with existing high field MR systems and MRS pulse sequence packages via a new protocol to conduct MRS exams of lumbar discs. The software suite is being designed to post-process this data to measure spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that may change with degeneration and pain.
The investigational Nociscan application exam includes two primary modules. A first module – the Nociscan MRS Pulse Sequence – is a software upgrade installation to standard 3T MRI systems with MRS capabilities.This instructs the MR system to run the uniquely directed MRS examination of the lumbar discs. The Nociscan application is being developed for use with existing MR systems and MRS pulse sequences already provided by the respective MR companies with clearance for use in assessing tissue chemistry, although operated under a new proprietary investigational protocol developed by Nocimed and specifically directed to MRS of discs. A second module – the Nociscan MRS Post-Processor – is being developed as an investigational software engine that receives information acquired during the Nociscan Pulse Sequence exam and processes that information through various algorithms to provide optimally robust MRS spectra, spectral measurements, and diagnostic results. The Nociscan MRS Post-Processor is currently housed and operated under an external server/computer with connectivity to the MR acquisition system via a picture archival communications system (PACS) network and internet.
Nocimed harnesses the existing power of Magnetic Resonance Spectroscopy (MRS) for non-invasive, objective quantification of relative chemical differences in tissues applied to assess the relative chemical biomarkers for tissue degeneration and pain.