A Trial Comparing Three Orthobiologic Therapies on Atrophied Multifidus Muscles in Patients With Low Back Pain

This study is a prospective, randomized controlled study of patients with atrophied
multifidus muscles and axial lower back pain that are randomized to one of 3 treatment
groups. Group 1 receives a series of 6 injections (1 time per week for 6 weeks) of platelet
poor plasma with an extracellular matrix (ECM) into multifidus. Group 2 receives a series of
6 injections (1 time per week for 6 weeks) of platelet rich plasma (PRP) into multifidus.
Group 3 receives a series of 3 injections (1 time every 2 weeks for 6 weeks) of PRP to
multifidus, as well as PRP into facet joint, as well as an epidural injection of platelet
lysate (PL).

Prior to procedure patient will undergo evaluation of medical history, back pain history,
lumbar examination, medication use and review MRI of lumbar spine.

While lying prone, the patient's back will be exposed and prepped sterilely. While
maintaining sterile technique, the physician will utilize US, x-ray or a combination of the
two to guide the needles bilaterally into the multifidus, specifically the area of treatment
using ultrasound, x-ray or a combination of the two. Once the lamina is reached the physician
will either inject autologous 2.5 cc PPP mixed with an ECM (group 1) or will inject
autologous 2.5 cc of 5x PRP into the multifidus muscle on one side and then repeat this on
the opposite side for each level (group 2 & 3).

Additionally, for patients in group 3, using sterile technique under fluoroscopic guidance,
the physician will guide a needle into the supraneural transforaminal space to perform an
epidural injection with 2cc of 3x PL and 1 cc of 0.5% ropivacaine. Next, a needle will then
be guided into the facet joint to perform an intra-articular injection with 1cc of 14x PRP.
After the procedure, the patient will be cleaned and bandaged. The patient will be given
standard rehab protocols to perform at home.

Patients will have follow-up visits with patient reported outcomes or pain and function at 3
months, 6 months and 12 months. A post-treatment MRI at 6 months will be compared to baseline
MRI to measure changes to multifidus atrophy.

Inclusion Criteria:

1. Voluntary signature of the Informed Consent

2. Axial low back pain for a minimum of 3 months

3. Male or female ages 18-75

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:

1. Mild multifidus atrophy Kader grade 1

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 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 six months of treatment

15. Any other condition, that in the opinion of the investigator, that would preclude the
patient from enrollment