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New scanner could help surgeons pinpoint the right discs to treat

NCT ID NCT06661850

Diagnosis Sponsor: Aclarion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a tool called NOCISCAN that uses a special type of MRI to find which discs in the lower back are causing pain. About 300 adults who are already planning back surgery will take part. Half of the surgeons will see the NOCISCAN results, and half will not, to see if the tool helps improve pain relief after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients presenting with back pain potentially caused by lumbar degenerative spine disease. Patients must be indicated for surgical treatment of their low back pain. Patients must also meet all study inclusion criteria and none of the study exclusion criteria.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Back Pain Low Back Pain lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Discogenic low back pain Low back pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Aurora Research Institute

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Endeavor Health

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Johns Hopkins Medicine

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Scripps Health

    RECRUITING

    La Jolla, California, 92037, United States

  • Texas Back Institute

    RECRUITING

    Plano, Texas, 75093, United States

  • Todd H. Lanman, M.D Inc

    RECRUITING

    Beverly Hills, California, 90210, United States

    Contact Email: •••••@•••••

  • USC Keck Medical Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Arizona

    RECRUITING

    Phoenix, Arizona, 85004, United States

  • University of Miami/ Jackson Health System

    RECRUITING

    Miami, Florida, 33136, United States

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