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NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study

2019-07-17 10:05:15 | BioPortfolio

Summary

A prospective, double blinded, multi-center study to assess the validity and clinical utility of the pre-operative NOCISCAN-LS software in the identification of painful lumbar discs, and the correlation with improved surgical outcomes at 3, 6, 12 and 24 months (follow-up) following spine surgery in a single enrollment arm of subjects with chronic symptomatic single level degenerative disc disease (DDD) at L3 to S1, but with two evaluation groups- Match Group and Miss Group,of subjects based on the association between the NOCISCORE results of treated and untreated disc levels.

Study Design

Conditions

Lumbar Disc Disease

Intervention

NOCISCAN-LS Disc MR Spectroscopy

Location

Texas Back Institute
Plano
Texas
United States
75093

Status

Recruiting

Source

Nocimed, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-17T10:05:15-0400

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Medical and Biotech [MESH] Definitions

An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.

The replacement of intervertebral discs in the spinal column with artificial devices. The procedure is done in the lumbar or cervical spine to relieve severe pain resulting from INTERVERTEBRAL DISC DEGENERATION.

The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.

Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.

Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.

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Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


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