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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618979
Recruitment Status : Terminated (Low enrollment)
First Posted : August 7, 2018
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

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

Condition or disease Intervention/treatment Phase
Low Back Pain Biological: PPP treatment Biological: PRP treatment Biological: PRP and PL Combo treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2, 2019
Actual Primary Completion Date : June 29, 2022
Actual Study Completion Date : June 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: 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)
Biological: PPP treatment
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.

Experimental: 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)
Biological: PRP treatment
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.

Experimental: 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)
Biological: PRP and PL Combo treatment
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.




Primary Outcome Measures :
  1. Post-treatment MRI [ Time Frame: 6 months ]
    Change in multifidus atrophy from baseline MRI


Secondary Outcome Measures :
  1. Single Assessment Numeric Evaluation Improvement Rating-modified [ Time Frame: 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

  2. Numeric Pain Scale [ Time Frame: 3 months, 6 months, 12 months ]
    Difference between groups for numeric pain scores where 0=no pain and 10=worst pain possible

  3. Functional Rating Index [ Time Frame: 3 months, 6 months, 12 months ]
    Difference between groups for function scores where 0=minimal disability and 100=severe disability

  4. Oswestry Low Back Disability Index [ Time Frame: 3 months, 6 months, 12 months ]
    Difference between groups for function scores where 0=minimal disability and 100=severe crippling disability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618979


Locations
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United States, Colorado
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021
Centeno-Schultz Clinic
Lone Tree, Colorado, United States, 80124
Sponsors and Collaborators
Regenexx, LLC
Investigators
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Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic
Publications:

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Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT03618979    
Other Study ID Numbers: RGX2018-RCT01
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regenexx, LLC:
regenerative medicine
low back pain
multifidus
platelet rich plasma
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations