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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oswestry Disability Index Assessment to assess improvement in lumbar pain
. 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
. Radiographic evidence of lumbar disc herniation with extrusion
. Clinically significant spinal canal stenosis as assessed by the Investigator
. Any significant motor strength deficit in lower extremities
. Suspicion of Sacro Iliac and/ or Facet joint pain as the primary pain generator;