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 injected into 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:
- Voluntary signature of the IRB approved Informed Consent
- Skeletally mature male or female ages 18-75
- Axial low back pain for a minimum of 3 months
- Recent MRI (within last 6 months) consistent Kader grade 2 or 3 multifidus atrophy at 1 or 2 levels
- 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:
- Mild multifidus atrophy Kader grade 1 only
- Multifidus atrophy at more than 2 levels
- Symptomatic spinal stenosis (e.g. pseudoclaudication with moderate or severe MRI findings of stenosis)
- Radicular symptoms (e.g. lower extremity radiating numbness, tingling, paresthesia, etc.)
- Fracture previous spine surgery, neuromuscular disease of the trunk, malignancy, infection, or pregnancy
- Radiofrequency Ablation (RFA) within the previous 12 months
- Corticosteroid injection (epidural or facet) within the past 3 months
- Contraindications for MRI
- Condition represents a worker’s compensation case
- Currently involved in a health-related litigation procedure
- Bleeding disorders
- Allergy or intolerance to study medication
- Use of chronic opioid
- Documented history of drug abuse within 6 months of treatment
- 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].