An interventional study of PPP treatment and PRP treatment in Low Back Pain, sponsored by Regenexx, LLC. Terminated at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by Regenexx, LLC · Not applicable, Interventional, and Treatment
To evaluate and compare the effectiveness of 3 different injection treatments on multifidus atrophy and lower 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 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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 8 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
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Exclusion Criteria:
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
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
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 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.
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.
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.
Post-treatment MRI
Change in multifidus atrophy from baseline MRI
Time frame: 6 months
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
Time frame: 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
Time frame: 3 months, 6 months, 12 months
Functional Rating Index
Difference between groups for function scores where 0=minimal disability and 100=severe disability
Time frame: 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
Time frame: 3 months, 6 months, 12 months
Plan to share: No
This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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