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

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

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial to Assess the Effects of Autologous Platelet Rich Plasma, Platelet Lysate, and Platelet Poor Plasma on Atrophied Multifidus Muscles in Patients With Axial Lower Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Biological: PPP treatment
* Biological: PRP treatment
* Biological: PRP and PL Combo treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary signature of the Informed Consent Axial low back pain for a minimum of 3 months Male or female ages 18-75 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: Mild multifidus atrophy Kader grade 1 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 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 six months of treatment Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPP treatment<br>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) | Biological: PPP treatment<br>* The day prior to or the morning of the procedure, patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of PPP depending on if there is lumbar multifidus atrophy in one or two levels. Using sterile technique and ultrasound guidance, once touching the lamina the physician will inject 2.5 cc of PPP. The physician will then repeat the procedure on the opposite side.<br>|
| Experimental: PRP treatment<br>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) | Biological: PRP treatment<br>* The day prior to or the morning of the procedure, patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of 5x PRP depending on if there is lumbar multifidus atrophy in one or two levels. Using sterile technique and ultrasound guidance, once touching the lamina the physician will inject 2.5 cc of PRP and remove the needle. The physician will then repeat the procedure on the opposite side and at the next level if indicated.<br>|
| Experimental: PRP and PL Combo treatment<br>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) | Biological: PRP and PL Combo treatment<br>* The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of 5x PRP and 5 or 10 cc of PL and 2 or 4 cc of 14x PRP depending on if there will be one or two levels injected. Using sterile technique, under ultrasound visualization into the lumbar multifidus and onto the lamina, the physician will inject the PRP and remove the needle. Under intermittent x-ray, epidural flow is confirmed with contrast, the physician will inject 2cc of the PL and 1cc of 0.5% ropivacaine into the epidural space. Once flow is confirmed for the epidural injection and facet with contrast, 1cc of the 14x PRP is injected into the facet joint. Procedure repeated on the opposite side and next level if indicated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment MRI | Change in multifidus atrophy from baseline MRI | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regenerative medicine, low back pain, multifidus, platelet rich plasma