Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Inclusion Criteria:

1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);

2. Subject plans to undergo surgical treatment of their discogenic back painindependent of this research protocol;

3. Subject is to be treated with on-label use of FDA-cleared or FDA-approved devicesindependent of this research protocol;

4. Subject has a diagnosis of discogenic back pain that requires treatment in up to twolumbar levels caused by degenerative disc disease (identified via MRI);

5. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100points (35/100);

6. Subject has a VAS back pain score of ≥40mm and that is greater than the worst VASleg 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, chiropracticcare, acupuncture, massage therapy or home-directed lumbar exercise programs) ORrequires 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 complywith this protocol including adhering to follow-up schedule and requirements andfilling out forms.

Exclusion Criteria:

1. Subject has a primary diagnosis of spinal condition other than degenerative discdisease at the involved level (i.e., facet joint pain/SI pain);

2. Subject has had prior lumbar back surgery or intradiscal treatments at any lumbarlevel (Note: diagnostic provocative or anesthetic discography are not excluded;micro-discectomy, decompression, or laminectomy patients greater than 6 monthspostop 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 clinicallyrelevant lumbar vertebral abnormalities (except Modic end-plate changes, which arenot 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 ineither compression or burst

• Lumbar kyphosis

7. Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbardisc 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 orbecoming pregnant), or are breast feeding, during the study period when scans willbe performed

10. Subject is currently receiving worker's compensation or is involved in in anylitigation for personal injury, medical negligence, trauma, or worker'scompensation.

11. Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, inthe opinion of the Principal Investigator, compromise a subject's ability to complywith study procedures, and/or may confound data

12. Subject has a BMI > 40