The Lumbar Matrix™ Scan has undergone blinded clinical studies at the Cleveland Clinic, Texas Back Institute and The Ohio State University College of Medicine.
Synopsis of Clinical Studies
A Lumbar Matrix™ Scan is based on Computerized Electrophysiological Reconstructed Spinal Regions (CERSR®) technology, which has been used for 12 years on more than 2,800 patients, with 612 subjects in controlled trials. More than 30,000 scans have been analyzed from subjects with and without low back pain (LBP). CERSR was cleared by the FDA in 1998 and is indicated to "Monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease and dysfunction."
Phase I work evaluated the normal human lumbar spine (1, 2). 314 subjects were screened for pre-existing pathology and the CERSR characteristics were analyzed. The normal human lumbar spine has distinctive images, power values, and sequences. These characteristics are stable over time, time of day and day of week regardless of gender, race or age. Subjects reporting a "sore back" have normal images with transiently elevated power values. Sequences remain normal.
In Phase II studies, 88 acute LBP subjects were studied to understand the natural history of acute LBP. Analysis showed that subjects fell into three subgroups, each with unique images, power values, sequences and recovery times. 17% had no unifying characteristics. As subjects recovered, CERSR data resumed normal images, power values and sequences. In subjects with low level pain complaints (<3⁄10 VAS) CERSR data tended to show normal images, power values and sequences.
Phase III studies involved 193 chronic LBP subjects at numerous institutions around the US. A carryover of acute images and sequence was observed and the facet and disc hypothesis was verified. Using discograms and facet joint blocks, patients with presumed facet joint pain were diagnosed by spine specialists at a large academic spine center using history, physical, radiographic and psychometric studies. Subjects were scheduled for a facet joint block and a CERSR test was performed before the block was administered. CERSR data was blindly reviewed at the end of the study and a positive response to a facet joint block was predicted by CERSR in 94.75% of cases. Physician prediction without CERSR was 50%.
At another institution, a second group of patients was evaluated for a single level discogram. Patients with presumed discogenic pain were diagnosed by spine specialists using history, physical, radiographic and psychometric studies and were scheduled for a discogram. A CERSR test was performed before the discogram and CERSR data was blindly reviewed at the end of the study. A positive discogram was predicted in 88% of subjects while physician prediction was 50%.
A retrospective analysis of the data shows that, of those subjects who had a negative facet joint block or a negative discogram, CERSR would have placed the subjects into the correct diagnostic category in 90% of cases.
Unique images, power values and sequences have been observed in spinal stenosis, spondylolisthesis and scoliosis and these conditions are now in experimental study.
Primary Clinical Studies & Publications
- Finneran MT, Mazanec D, Marsolais M, Marsolais E, Pease WS. Large Array Surface Electromyography and Low Back Pain: A Pilot Study. Spine. 2003; 28(13); 1447-1454.
- Finneran M.T. Physiological Imaging of the Low Back: Normative Values for Large-Array Surface Electromyography. Journal of Disability, August 2001, 15-21.
- Reger SI, Shah A, Adams TC, et. al. Classification of Large Array Surface Myoelectric Potentials from Subjects with and without Low Back Pain, Journal of Electromyography and Kinesiology. 2006; 16(1): 392-401.
- Analysis of Surface Myoelectric Potentials in Low Back Pain Patients. Spinal Column, Cleveland Clinic Spine Institute, Fall 2006, 6-7.
- Pease WS, Clairmont AC, Finneran MT. Large Array Surface Electromyography in Acute Non-radicular Low Back Pain. (Ohio State)
- Triano JJ, Buckles J, Guyer RD. Large-Array Surface EMG Monitoring of Low Back Patients with Disk Disease. (Texas Back Institute)
- Ranganathan VK, Reger SI, Butler RS, Endredi JJ, Sahgal V, Mekhail NA, Mazanec DJ. Classification of Facet Joint Nerve Block Outcomes in Low Back Patients Using Large Array Surface Myoelectric Potentials. (Cleveland Clinic)
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