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.
Physical examination: e.g. for functional deficits and pain distribution profile
Standard imaging techniques: e.g. MRI, X-ray, myelogram
Selective Nerve Blocks: Needles are injected into a spinal nerve, sacroiliac joint, facet or medial joints in attempt to isolate the pain source if pain is alleviated
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
Nocimed harnesses the existing power of Magnetic Resonance Spectroscopy (MRS), a derivative of Magnetic Resonance Imaging (MRI), 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 in lumbar discs.
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 via a patented post-processor engine that post-processes MRI and MRS exam data acquired via leading commercial high field MR scanners and spectroscopy pulse sequences.
NOCISCAN-LS results are correlated with the results of a more invasive and painful discography reference test for identifying painful discs, but without requiring the discogram to be conducted. NOCISCAN-LS clinical trial results were also correlated with improved outcomes for patients who received surgery at the discs identified with the highest relative scores for degenerative painful disc chemicals.
By providing this new information, NOCIMED is being positioned as a partner with Radiologists and MR Imaging Centers to enhance the value of NOCISCAN-LS exams (lumbar MRI+MRS) for low back pain patients and their referring doctors. NOCISCAN-LS™ is CE Marked technology platform that was developed through a Nocimed-sponsored clinical trial to provide a non-invasive, pain-free, objective test to assist in the diagnosis of lumbar disc pain.
NOCISCAN-LS results are correlated with the results of a more invasive and painful discography reference test for identifying painful discs, but without requiring the discogram to be conducted. NOCISCAN-LS clinical trial results were also correlated with improved outcomes for patients who received surgery at the discs identified with the highest relative scores for degenerative painful disc chemicals
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.
It starts with an MR Spectroscopy scan. Then, using our proprietary measurement system, each disc is evaluated for spectral signatures for pain biomarkers derived from degenerative pain biomarkers.
A three-dimensional volume is defined by a ‘box’ drawn by the MR operator/technician in the disc nucleus of the MRI images. This is then “vibrated” by the MR scanner using a proprietary NOCISCAN-LS exam protocol using existing MRS pulse sequences, but optimized for the specific application to discs.
The acquired data is uploaded to a secured cloud-based post-processor for analysis. Signals acquired from the nucleus are processed by NOCISCAN-LS™ post-processing software to create MRS spectra. Spectral signatures are then measured as inputs to a diagnostic algorithm to generate a “NOCISCORE” that is correlated, per a clinical trial, to the results of another invasive reference discography test for pain (but which the NOCISCAN-LS exam allows to be avoided).
A NOCIGRAM-LS Report is then returned from the cloud post-processor back into the patient’s records in the originating PACS network. This report provides an intuitive format to show the relative degenerative painful chemical comparisons between discs to assist a doctor, in combination with other available patent data, in diagnosing disc conditions, such as discogenic pain and/or degenerative disc disease.
NOCISCAN-LS™ is a software suite that works 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 post-processes the NOCISCAN-LS disc MRS exam data to measure spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that change with degeneration and pain.
The NOCISCAN-LS platform includes two primary modules. A first module – the NOCISCAN-LS Disc MRS Exam Protocol – is a set of custom settings and parameters for using an existing, customizable MRS pulse sequence that is commercially available by the MR scanner manufacturer as an option or upgrade installation to standard high field (3T or 1.5T) MRI systems with MRS capabilities. This NOCISCAN-LS Exam protocol instructs the MR system to run the uniquely directed MRS examination of the lumbar discs. Initially, this is limited for compatible use with certain specified 1.5T and 3.0T MR systems and related MRS pulse sequences that are commercially available from Siemens. A second module – the NOCISCAN-LS disc MRS Post-Processor – is a cloud-based software engine that receives the information acquired during the NOCISCAN-LS exam and processes that information through various algorithms to provide optimally robust MRS spectra, spectral measurements, and calculated chemical assessment results. The NOCISCAN-LS disc MRS Post-Processor is currently hosted in a secured and protected environment via a leading commercial cloud-host vendor, with data transport connectivity via a secured internet gateway with a picture archiving and communications system (PACS) network associated with the MR scanner.
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.