Study for Patients with Lumbar Degenerative Disc Disease

Patients must be able to visit the Centeno-Schultz Clinic in Broomfield, CO for evaluation, two treatment procedures spaced 1-month apart, in addition to two follow-up visits after the 2nd procedure, at a minimum.

Our Research Team is conducting a study investigating how a series of two platelet-based treatments (made from a patient’s own blood) affect symptoms of lumbar degenerative disc disease. Patients in the study will be randomly assigned to receive either two real treatments or two sham control procedures (to mimic spine injection treatment, although nothing is injected), in a 2:1 allocation. Hence 28 patients will be assigned to the treatment group and 14 to the sham control group. Patients assigned to the control group can cross-over to the treatment group at the 3-month follow-up visit, when all patients are notified as to which study group they had been assigned. Patient reported outcomes surveys will be completed before treatment, as well as at 1-, 3-, 6-, and 12-months.

All patients will need a lumbar MRI or lumbar flexion-extension x-ray to determine if they are a candidate.

Candidates must meet ALL of the following:

• Skeletally mature male or female ages 25-65
• Maximum of 3 levels of 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, i.e., fusion, decompression, etc.)
• Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Candidates will be excluded if they meet ANY of the following:

• Evidence of more than moderate central canal or foraminal
• 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 last 8 weeks
• Degenerative scoliosis if cob angle over 10 degrees
• Undergone previous Regenexx lumbar procedure
• Standing intolerance (patient cannot stand longer than 30 mins)
• Inflammatory or auto-immune based joint diseases or other lower extremity pathology
• 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
• Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

If you are interested in seeing if you are a candidate for participating in this study, please email Ehren Dodson, PhD, Clinical Research Director, at [email protected] or call 720-287-7199.