Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes
NCT ID: NCT06661850
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-06-11
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Blinded-to-NOCISCAN
NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.
Fusion or TDR determined by investigator.
The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Unblinded-to-NOCISCAN
NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.
Fusion or TDR determined by investigator.
The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Interventions
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Fusion or TDR determined by investigator.
The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Eligibility Criteria
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Inclusion Criteria
2. Subject 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 diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI);
5. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
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) OR requires urgent surgical treatment per the investigator;
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.
Exclusion Criteria
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 severe 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 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
7. Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc 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
18 Years
70 Years
ALL
No
Sponsors
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MCRA
INDUSTRY
Aclarion
INDUSTRY
Responsible Party
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Locations
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Scripps Health
La Jolla, California, United States
USC Keck Medical Center
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Advocate Aurora Research Institute
Park Ridge, Illinois, United States
Texas Back Institute
Plano, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Joy Biggers
Role: primary
Edgar Martinez Sanchez
Role: primary
Adriana Saravia
Role: primary
Lidia Hrvojevic
Role: primary
Victor Arroyo
Role: primary
Shannon Rusch
Role: primary
Related Links
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Related Info
Other Identifiers
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Clarity
Identifier Type: -
Identifier Source: org_study_id