RECRUITING

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Conditions

Discogenic Low Back Pain MR Spectroscopy MRI back pain Nociscan

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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."

Official Title

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

Quick Facts

Study Start:2025-05

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06661850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Ryan Bond

CONTACT

724-991-3369

rbond@aclarion.com

Teleah Davis

CONTACT

tdavis@mcra.com

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Advocate Aurora Research Institute

Park Ridge, Illinois, 60068

United States

Texas Back Institute

Plano, Texas, 75093

United States

Collaborators and Investigators

Sponsor: Aclarion

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-05

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

MR Spectroscopy
MRI
back pain
Nociscan

Additional Relevant MeSH Terms

Discogenic Low Back Pain