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 Type
OBSERVATIONAL
Enrollment
240
The investigational Nociscan Suite is a software suite that works with existing high field MR systems and MRS pulse sequence via and optimized protocol to conduct MRS exam of lumbar discs. The software suite post-processes the NOCISCAN-LS disc MRS exam data to calculate ratios of spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that change with degeneration and pain
Texas Back Institute
Plano, Texas, United States
Oswestry Disability Index Assessment to assess improvement in lumbar pain
Oswestry Disability Index is an index derived from Oswestry Low Back Pain Questionnaire used in several studies to quantify disability for low back pain. Each of the 10 items is scored from 0-5. The maximum score is therefore 50. This will be completed at 12 month follow up to see if there is an improvement of at least 15 points at 12 months Follow-up for Match Group versus Miss Group subjects. Mean Oswestry Disability Index score changes at 3, 6 and 24 months post-operative follow-up will be evaluated for Match versus Miss Group
Time frame: 24 months
Visual Analog Scale (VAS) to assess the intensity of pain
Visual Analog Scale for pain is a validated tool used in determining the subjective level of pain in an individual. It will be completed at Mean Visual Analog Scale score changes for back pain at 3,6, 12 and 24 months post-op follow up for Match versus Miss Group
Time frame: 2 years
Demonstrate correlation of NOSCISCORE results to Provocative Discography +/- results in subset of study subjects that receive pre-operative provocative discogram
Compare NOCISCORE results for Provocative discography positive discs versus Provocative discography negative discs in study subjects receiving pre-operative discogram
Time frame: 24 months
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