Examination of Nociscan Impact on 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 intends to undergo instrumented surgical treatment in the lumbar spinal discfor their lower back pain, independent of this research protocol;

3. Subject is to be treated with FDA-cleared or FDA-approved devices independent ofthis research protocol;

4. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100points (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, chiropracticcare, acupuncture, massage therapy or home-directed lumbar exercise programs) ORrequires 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 complywith this protocol including adhering to follow-up schedule and requirements andfilling out forms.

Exclusion Criteria:

1. 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);

2. Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinicallyrelevant lumbar vertebral abnormalities (except Modic end-plate changes, which arenot 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 ineither 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 orbecoming pregnant), or are breast feeding, during the study period when scans willbe 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 opinionof the Principal Investigator, compromise a subject's ability to comply with studyprocedures, and/or may confound data