Clinical trial NCT06661850: Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes
Official title: A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Discogenic Low Back Pain
Keywords: MR Spectroscopy
MRI
back pain
Nociscan
Lead sponsor: Aclarion
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2024-10-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with a primary diagnosis of discogenic back pain caused by lumbar degenerative disc disease. Patients may be symptomatic at one level or two levels. Patients must be indicated for surgical treatment of their discogenic low back pain. Patients must also meet all study inclusion criteria and none of the study exclusion criteria.

Brief summary: This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."


Eligibility criteria: Inclusion Criteria:

1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
2. Subject is 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 primary diagnosis of discogenic back pain in up to two lumbar levels caused by degenerative disc disease identified via MRI;
5. Subject has a preoperative Oswestry Disability Questionnaire score ≥40 out of 100 points (40/100);
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);
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 clinically significant 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 with more than 2 mm of translation, or with 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 lumbar disc herniation comprising 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

Primary outcomes:
measure: Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: 20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment
timeFrame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
measure: 20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment
timeFrame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
measure: Patient reported treatment satisfaction survey
timeFrame: Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
measure: Patient-Reported Outcome Measurement Information System (PROMIS) 29 score
timeFrame: Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
measure: Cumulative proportion of responders (CPRA) for 15 point Oswestry Disability Index (ODI) change (out of 100)
timeFrame: From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
measure: Absence of Secondary surgical intervention
timeFrame: From Baseline through study completion, 24-Months
measure: Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores
timeFrame: From Baseline through study completion, 24-Months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Aurora Research Institute
state: Illinois
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
References: