Clinical Studies

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 click here to submit a prescreen application, or for any questions you may have email Ehren Dodson, PhD, Clinical Research Director, at [email protected] or call 720-287-7199.

Study Application

Alar Study Requirements

• The patient must be willing to come to the Broomfield clinic for evaluation to make a determination of study eligibility
• There is no guarantee they will be eligible
• The patient must have a current digital motion x-ray (DMX) for screening purposes
• The patient must have received and not responded long-term to upper cervical facets and ligament injections
• If eligible, the patient must be willing to return to clinic for treatment and follow-up visits (6 and 12 months), as well as complete 6-month DMX in Boulder, CO
• Enrolled patients are randomized and blinded to study condition of either the treatment condition or sham condition. Treatment involves a bone marrow aspiration and injection of the bone marrow concentrate (Regenexx-SD) into the alar, accessory and transverse ligaments via injection through the back of the throat under anesthesia. The sham procedure involves a “mock injection” which involves a needle poke to the back of the throat on each side while under anesthesia. Patients are unblinded to study condition at 6-month visit. Patients in the sham condition are given the opportunity to crossover into the treatment condition after 6-months upon learning they were in the sham condition.
• Patients complete online surveys at 1-month, 3-months, 6-months and 12 months post-procedure
• Treatments and study-related follow-up visits and 6-month DMX are provided at no cost to patient
• Costs of any travel will be the responsibility of the patient

The patient must meet all inclusion criteria and none of the exclusion criteria for the study to be eligible. Final determination of study eligibility made by principle investigator

Inclusion criteria

Candidates must meet ALL of the following:

1. Voluntary signature of the IRB approved Informed Consent
2. Skeletally mature male or female ages 18-65
3. Must have a specific inciting injury event that occurred less than 10 years ago where the patient experienced trauma that caused the problem-meaning from that day on, they had the symptoms for which they are now seeking treatment
4. Upper cervical symptoms predominate: Patient must have a headache since the event and must have one of the following: dizziness, vertigo, imbalance, or visual disturbances
5. Patient must be able to care for themselves without assistance
6. NDI percentage score (raw NDI score times 2) at least 30 (moderate disability)
7. Imaging: Must have DMX overhang of at least 3mm or grabb-oakes of >9mm on cervical flexion MRI-change in signal on static imaging does not qualify the patient
8. Hasn’t responded long-term to conservative care
9. Upper cervical fusion candidate
10. Exam is c/w upper cervical injury (i.e. tenderness along upper cervical facet joints and/or musculature/skull base, proprioceptive difficulties)
11. Is independent, ambulatory, and can comply with all post-operative evaluations and visits
12. Patient states strong desire to avoid surgery

Exclusion Criteria

1. Known or diagnosed EDS based on Beighton criteria: https://www.physio-pedia.com/Beighton_score
2. Lower or mid-cervical symptomatic disease (tenderness in mid to lower cervical facets, radiculopathy, radiating symptoms into shoulder blade, epicondylitis, numbness and tingling in hands)
3. Prior spinal fusion or surgery at any segment in cervical, thoracic, or lumbar spine
4. NDI % score > than 56 (severe disability), unless at the discretion of the independent physician review
5. Prior or current history of a metabolic disorder like diabetes, anorexia, other eating disorder, BMI>40
6. Unable to tolerate injections due to central sensitization (i.e. significant intolerance to manual therapy such as massage, activity such as physical therapy, or an exaggerated pain response to prior injection therapy)
7. Prior epidural or other milligram dose steroid injection in any area within the past 6 months
8. Prior prolotherapy or platelet-based injections to the cervical spine within the last 3 months
9. Prior radiofrequency ablation to the cervical spine within the last 2 years
10. Physical infirmity that is incompatible with the procedure and/or anesthesia required for same
11. Unable to tolerate the injection position
12. Abnormal anatomy seen on MRI imaging that would make the procedure higher risk (e.g. congenital atlanto-axial fusion, atlas assimilation, upper cervical fracture or surgical fusion)
13. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudo gout)
14. Quinolone or Statin induced myopathy/tendinopathy
15. Condition represents a worker’s compensation case
16. Currently involved in a health-related litigation procedure
17. Is pregnant
18. Bleeding disorders
19. Currently taking anticoagulant or immunosuppressive medication
20. Allergy or intolerance to study medication
21. Use of and significant physical dependence on a chronic opioid (>20 mg oxycodone equivalent per day)
22. Documented history of drug abuse within 6 months of treatment
23. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

If you meet all of the criteria and are able to travel to the research study location for all of the required follow-up visits, please contact us at 720-669-8330 or via email at [email protected].