Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Inclusion criteria

• Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
• Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
• Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
• 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);
• Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
• Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
• 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;
• Subject has signed the IRB approved Informed Consent Form; and
• 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

• Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
• 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);
• Surgery is planned for more than 2 lumbar levels.
• Subject has severe spinal canal stenosis as assessed by the Investigator;
• Subject has a motor strength deficit(s) in lower extremities
• 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
• Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
• Subject is contraindicated for a standard lumbar MRI exam
• 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
• Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
• 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
• Subject has a BMI > 40