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 404.800.0302. or via email at [email protected].

Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
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Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
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Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
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Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
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Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
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Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

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