Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes (CLARITY)

Aclarion

Status: Enrolling

Conditions: Discogenic Low Back Pain

Treatments: Procedure: Fusion or TDR determined by investigator.

Study type: Observational

Funder types: Industry

Identifiers

NCT06661850

Clarity

Details and patient eligibility

About

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."

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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

Trial design

300 participants in 2 patient groups

Blinded-to-NOCISCAN

Description:

NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.

Treatment:

Procedure: Fusion or TDR determined by investigator.

Unblinded-to-NOCISCAN

Description:

NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.

Treatment:

Procedure: Fusion or TDR determined by investigator.