Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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
- * 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
Ages Eligible for Study
25 Years to 65 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No