Examining the impact of Nociscan on back pain surgery outcomes

A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain

This study is testing if a new software tool called Nociscan can help improve surgery results for people with low back pain by better identifying which discs are causing pain.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Aclarion (Industry-sponsored)
• Locations: 8 sites (Beverly Hills, California and 7 other locations)
• Trial ID: NCT06661850 on ClinicalTrials.gov

What this trial studies

This observational study investigates the safety and effectiveness of Nociscan, a software tool that utilizes Magnetic Resonance (MR) spectroscopy to help differentiate between painful and nonpainful discs in the lumbar spine. The study will compare surgical outcomes of patients who receive Nociscan reports prior to treatment against those who do not, using both blinded and unblinded cohorts. Participants will be individuals scheduled for surgery due to discogenic low back pain, and their outcomes will be assessed based on the Nociscan findings.

Who should consider this trial

Good fit: Ideal candidates are skeletally mature adults aged 18 to 70 with a primary diagnosis of discogenic low back pain who have not responded to at least six months of non-operative treatment.

Not a fit: Patients who are not planning to undergo surgical treatment for their back pain or those with non-degenerative causes of back pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance surgical decision-making for patients with discogenic low back pain, potentially leading to better outcomes.

How similar studies have performed: While this approach is innovative, similar studies utilizing MR spectroscopy for pain differentiation have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
2. Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
3. Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
4. Subject has a diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI);
5. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
6. Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
7. Subject has failed at least ≥ 6 months of non-operative treatment (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator;
8. Subject has signed the IRB approved Informed Consent Form; and
9. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.

Exclusion Criteria:

1. Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
2. Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);
3. Surgery is planned for more than 2 lumbar levels.
4. Subject has severe spinal canal stenosis as assessed by the Investigator;
5. Subject has a motor strength deficit(s) in lower extremities
6. Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including:

   * Spondylolisthesis Grade 2 or greater (up to Grade 1 is accepted)
   * Pars fracture, at the involved level
   * Spondylolysis
   * Lumbar scoliosis with a Cobb angle of greater than 15°
   * Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst
   * Lumbar kyphosis
7. Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
8. Subject is contraindicated for a standard lumbar MRI exam
9. Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed
10. Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
11. Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and/or may confound data
12. Subject has a BMI \> 40

Where this trial is running

Beverly Hills, California and 7 other locations

• Todd H. Lanman, M.D Inc — Beverly Hills, California, United States (Recruiting)
• Scripps Health — La Jolla, California, United States (Recruiting)
• USC Keck Medical Center — Los Angeles, California, United States (Recruiting)
• University of Miami — Miami, Florida, United States (Recruiting)
• Northwestern University — Chicago, Illinois, United States (Recruiting)
• Advocate Aurora Research Institute — Park Ridge, Illinois, United States (Recruiting)
• Johns Hopkins Medicine — Baltimore, Maryland, United States (Recruiting)
• Texas Back Institute — Plano, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Ryan Bond

Conditions Discogenic Low Back Pain; MR Spectroscopy; MRI; back pain; Nociscan