Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

NCT06661850 | Recruiting DMC FDA Device

• 1 other identifier: Clarity
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 8

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."

Conditions

Discogenic Low Back Pain

Keywords

MR Spectroscopy; MRI; back pain; Nociscan

Outcome Measures

Primary Outcomes (1)

• Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment

  The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline. VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.

  Baseline to 12 months

Secondary Outcomes (7)

• 20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment

  From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)

• 20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment

  From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)

• Patient reported treatment satisfaction survey

  Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)

• Patient-Reported Outcome Measurement Information System (PROMIS) 29 score

  Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)

• Cumulative proportion of responders (CPRA) for 15 point Oswestry Disability Index (ODI) change (out of 100)

  From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)

Study Arms (2)

Blinded-to-NOCISCAN

NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.

Procedure: Fusion or TDR determined by investigator.

Unblinded-to-NOCISCAN

NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.

Procedure: Fusion or TDR determined by investigator.

Interventions

Fusion or TDR determined by investigator. PROCEDURE

The surgical treatment will be decided by the treating investigator based on their clinical judgement.

Blinded-to-NOCISCAN; Unblinded-to-NOCISCAN

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with back pain potentially 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.

You may qualify if:

• Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
• Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
• Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
• 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);
• Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
• Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
• 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;
• Subject has signed the IRB approved Informed Consent Form; and
• 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.

You may not qualify if:

• Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
• 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);
• Surgery is planned for more than 2 lumbar levels.
• Subject has severe spinal canal stenosis as assessed by the Investigator;
• Subject has a motor strength deficit(s) in lower extremities
• 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
• Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
• Subject is contraindicated for a standard lumbar MRI exam
• 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

Sponsors & Collaborators

• Aclarion: lead
• MCRA: collaborator

Study Sites (8)

Todd H. Lanman, M.D Inc

Beverly Hills, California, 90210, United States

RECRUITING

Scripps Health

La Jolla, California, 92037, United States

RECRUITING

USC Keck Medical Center

Los Angeles, California, 90033, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Advocate Aurora Research Institute

Park Ridge, Illinois, 60068, United States

RECRUITING

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Texas Back Institute

Plano, Texas, 75093, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Back Pain

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Central Study Contacts

Ryan Bond

CONTACT

724-991-3369; rbond@aclarion.com

Andy Murillo

CONTACT

amurillo@aclarion.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: June 11, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (8)