Multifidus/Low Back Pain Study

Multifidus Study Requirements

• The patient must be willing to come to the Broomfield or Lone Tree clinic for initial evaluation to make a final determination of study eligibility
• There is no guarantee they will be eligible
• The patient must have a current MRI within last 6 months for screening purposes
• If eligible, the patient must be willing to return to either clinic for all treatments (series of injections for 6 weeks) and follow-up visits (3 months, 6 months and 1 year). Physical therapy visits only occur at the Broomfield clinic on weeks 1 and 3 in conjunction with treatment
• Costs of any travel will be the responsibility of the patient
• The patient will be randomized to one of 3 treatment conditions:
  • • Group 1: Platelet poor plasma combined with an extracellular matrix (ACell MicroMatrix) injected to the multifidus muscle (6 weekly treatments)
    • Group 2: Platelet rich plasma injected into the multifidus muscle (6 weekly treatments)
    • Group 3: Platelet rich plasma injected into the multifidus and facet joints, platelet lysate injected into the nerves (epidural) (series of 3 every 2 weeks)
• Treatments are at no cost to patient
• Patients will know the condition to which they have been randomized
• Patients must be able to undergo blood draws for each treatment
• The patient must meet all inclusion criteria and none of the exclusion criteria for the study to be eligible. Key criteria include:
  • Axial low back pain for at least 3 months
  • Age 18-75
  • Recent MRI consistent with Kader grade 2 or 3 multifidus atrophy at 1 or 2 levels
  • No more than 2 levels of multifidus atrophy Kader grade 2 or 3
  • No symptomatic spinal stenosis
  • No radicular symptoms (lower extremity numbing or tingling)
  • No previous spine surgery
  • No corticosteroid injection to spine within the last 3 months

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 18-75
3. Axial low back pain for a minimum of 3 months
4. Recent MRI (within last 6 months) consistent Kader grade 2 or 3 multifidus atrophy at 1 or 2 levels
5. Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria

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

1. Mild multifidus atrophy Kader grade 1 only
2. Multifidus atrophy at more than 2 levels
3. Symptomatic spinal stenosis (e.g. pseudoclaudication with moderate or severe MRI findings of stenosis)
4. Radicular symptoms (e.g. lower extremity radiating numbness, tingling, paresthesia, etc.)
5. Fracture previous spine surgery, neuromuscular disease of the trunk, malignancy, infection, or pregnancy
6. Radiofrequency Ablation (RFA) within the previous 12 months
7. Corticosteroid injection (epidural or facet) within the past 3 months
8. Contraindications for MRI
9. Condition represents a worker’s compensation case
10. Currently involved in a health-related litigation procedure
11. Bleeding disorders
12. Allergy or intolerance to study medication
13. Use of chronic opioid
14. Documented history of drug abuse within 6 months of treatment
15. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

If you meet all of the criteria for a study and are able to travel to the research study location for all of the required follow-up of visits, please contact us at 888-525-3005. or via email at [email protected].