NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study
United States240 participantsStarted 2023-04-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Has history consistent with degenerative disc disease as noted by back pain of discogenic origin with or without leg pain
✓. Has one of more of the following conditions as documented by CT or MRI and plain X-rays:
✓. Modic changes
✓. High intensity zones in the annulus
✓. Loss of discogenic height
✓. Decreased hydration of the disc
✓. Has single level symptomatic degenerative involvement from L3 to S1 in which surgical treatment is indicated
✓. Skeletally mature male or female (non-pregnant) between 18 and 70 years of age
Exclusion criteria
✕. Has primary diagnosis of spinal condition other than degenerative disc disease at the involved level;
✕. Has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy +- laminectomy patients greater than 6 months postop are not excluded)
✕. Surgery planned at more than one level
✕. Radiographic evidence of clinically relevant lumbar vertebral abnormalities, including
✕
What they're measuring
1
Oswestry Disability Index Assessment to assess improvement in lumbar pain