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

Not Applicable

Terminated

• Conditions: Low Back Pain
• Interventions: Biological: PPP treatment; Biological: PRP treatment; Biological: PRP and PL Combo treatment

• Registration Number: NCT03618979
• Lead Sponsor: Regenexx, LLC

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-07
• Study Start: 2019-05-02
• Primary Completion: 2022-06-29
• Study Completion: 2022-06-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPP treatment	PPP treatment	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)
PRP treatment	PRP treatment	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)
PRP and PL Combo treatment	PRP and PL Combo treatment	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)

Primary Outcome Measures

Name	Time	Method
Post-treatment MRI	6 months	Change in multifidus atrophy from baseline MRI

Secondary Outcome Measures

Name	Time	Method
Single Assessment Numeric Evaluation Improvement Rating-modified	3 months, 6 months, 12 months	Difference between groups for mean improvement scores where -100=100% worse from baseline and 100=100% improved from baseline
Functional Rating Index	3 months, 6 months, 12 months	Difference between groups for function scores where 0=minimal disability and 100=severe disability
Oswestry Low Back Disability Index	3 months, 6 months, 12 months	Difference between groups for function scores where 0=minimal disability and 100=severe crippling disability
Numeric Pain Scale	3 months, 6 months, 12 months	Difference between groups for numeric pain scores where 0=no pain and 10=worst pain possible

Trial Locations

Locations (1)

Centeno-Schultz Clinic; 🇺🇸 Lone Tree, Colorado, United States