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NCT Number: NCT06661850

Examination of Nociscan Impact on Low Back Pain Surgical Outcomes

This study is looking into how useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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);
  • 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
  • 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
  • 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

Treatment and study plan

Fusion or TDR determined by investigator.

Procedure

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

Primary outcomes

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

    Time frame: Baseline to 12 months

    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.

Secondary outcomes

  1. 20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment

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

    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.

  2. 20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment

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

    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.

  3. Patient reported treatment satisfaction survey

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

    Patient Satisfaction survey is a self-reported questionnaire to measure the subject's satisfaction of the treatment under the protocol.

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

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

    The PROMIS-29 v2. 0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.

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

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

    The Oswestry Disability Index (ODI) is a 10-item questionnaire that scores disability on a percentile scale from 0-100%. The ODI score is interpreted as follows:

    0-20%: Minimal disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Crippling effects 80-100%: Completely disabled and bedbound

  6. Absence of Secondary surgical intervention

    Time frame: From Baseline through study completion, 24-Months

    Secondary surgical interventions may include revision, reoperation, removal or supplemental fixation at any level in the lumbar spine.

  7. Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores

    Time frame: From Baseline through study completion, 24-Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andy Murillo

CONTACT

[email protected]

Ryan Bond

CONTACT

[email protected]

724-991-3369

Sponsors and collaborators

Lead sponsor

Aclarion

Industry

Collaborators

  • MCRA

Registry information

Official study title

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

Acronym: CLARITY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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