Examining the impact of Nociscan on back pain surgery outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
2. Subject intends to undergo instrumented surgical treatment in the lumbar spinal disc for their lower back pain, independent of this research protocol;
3. Subject is to be treated with FDA-cleared or FDA-approved devices independent of this research protocol;
4. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
5. Subject has a VAS back pain score of ≥40mm;
6. 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;
7. Subject has signed the IRB approved Informed Consent Form; and
8. 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 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);
2. 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:

   * Grade 3 Spondylolisthesis (Grade 1 or Grade 2 is allowed)
   * Pars fracture, at the involved level
   * Spondylolysis
   * Lumbar scoliosis with a Cobb angle of greater than 20°
   * Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst
   * Lumbar kyphosis
3. Subject is contraindicated for a standard lumbar MRI exam
4. 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
5. Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than 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

Where it's running

• University of Arizona
  Phoenix, Arizona, United States Recruiting
• 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/ Jackson Health System
  Miami, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Ryan Bond
• Email: rbond@aclarion.com
• Phone: 724-991-3369

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.