trial for treating painful degenerative disc disease

Conditions: Degenerative Disc Disease

Summary: to evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.

this is a single-blind, randomized, placebo-controlled study using platelet-based treatment to the functional spinal unit .in a series of 2 treatments 4 weeks apart to treat painful lumbar degenerative disc disease. randomization is 2:1, with 28 in the treatment group and 14 in the sham control group. a pretreatment visit will occur at or before the time of enrollment; follow-up visits will occur at the clinical site at 3- and 12 months post injection. target enrollment is 42 subjects. patients in the control group can crossover to the treatment group after 3-month follow-up. crossover patients then follow the treatment group follow-up timeline based on their second real treatment. subjects will complete the study following the 1-year follow-up visit. the primary objective of this study is to observe the improvement in subject-reported clinical outcomes from baseline to 3 months after 2nd treatment and between groups at 3 months, with continued evaluation of efficacy and durability up to 12 months. questionnaires are completed at 1, 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * voluntary signature of the irb approved informed consent, * skeletally mature male or female ages 25 to 65 * maximum of 3 levels degenerative disc disease without significant spondylolisthesis in the area c/w the pain (grade 1 with less than or equal to 10% vertebral body) * chronic back and/or leg pain having failed conservative treatment (e.g. nsaids, physician initiated physical therapy) for at least 6 months * mri and physical examination consistent with painful degenerative disc disease * failure of epidural steroid injection, facet injection, medial branch block, radiofrequency ablation or physical therapy * instability as seen on mri, flexion-extension x-ray, or physical deformity as seen on mri c/w degenerative instability (facet hypertrophy, loss of disc height, spondylolisthesis, laterolisthesis, osteophytes) * a lumbar surgery candidate (will need to specify which surgery, ie. fusion, decompression, etc) * is independent, ambulatory, and can comply with all post-operative evaluations and visits exclusion criteria: * evidence of more than moderate central canal or foraminal stenosis * smoker or cessation for less than 6 weeks * untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor to chronic pain * prior epidural steroid injection within the past 8 weeks * degenerative scoliosis if cob angle over 10 degrees * undergone previous regenexx lumbar procedure * standing intolerance (patient cannot stand longer than 30 minutes) * inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) * severe neurogenic inflammation of the cutaneous nerves * condition represents a worker's compensation case * currently involved in a health-related litigation procedure * is pregnant * bleeding disorders * currently taking anticoagulant or immunosuppressive medication * allergy or intolerance to study medication * use of chronic opioid * documented history of drug abuse within six months of treatment * central sensitization * hypermobile or eds * 19) any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment