Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Conditions

• Discogenic Low Back Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Fusion or TDR determined by investigator. — PROCEDURE
  The surgical treatment will be decided by the treating investigator based on their clinical judgement.

Study Details

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."

Key Dates

Start date

Jun 11, 2025

Status verified

May 2026

Primary completion

Sep 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Blinded-to-NOCISCAN
  NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.
• Arm: Unblinded-to-NOCISCAN
  NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.

Primary Outcome Measure

Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment [ Time Frame: Baseline to 12 months ]

Central Contacts

• Ryan Bond
  724-991-3369
  [email protected]
• Andy Murillo
  [email protected]

Locations (8)

Find similar trials in Beverly Hills, CA

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