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

Regenexx

Status: Terminated

Conditions: Low Back Pain

Treatments: Biological: PRP treatment; Biological: PRP and PL Combo treatment; Biological: PPP treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03618979

RGX2018-RCT01

Details and patient eligibility

About

To evaluate and compare the effectiveness of 3 different injection treatments on multifidus atrophy and lower back pain.

Full description

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 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 (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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 3 patient groups

PPP treatment

Experimental group

Description:

Platelet Poor Plasma (PPP) into the multifidus on each side and at each level 1 time per week for 6 weeks (series of 6 injections)

Treatment:

Biological: PPP treatment

PRP treatment

Experimental group

Description:

5x concentration Platelet Rich Plasma (PRP) injected into the multifidus on each side and at each level 1 time per week for 6 weeks (series of 6 injections)

Treatment:

Biological: PRP treatment

PRP and PL Combo treatment

Experimental group

Description:

5x concentration PRP injected into the multifidus, along with a facet joint injection with 14x PRP into each joint and capsule, and transforaminal epidural injection with of 3x concentrated platelet lysate (PL) and 0.5% ropivacaine on each side and at each level 1 time every 2 weeks for 6 weeks total (series of 3 injections)

Treatment:

Biological: PRP and PL Combo treatment