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

NCT03618979 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-07-08

No results posted yet for this study

Summary

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

Conditions

  • Low Back Pain

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Regenexx, LLC

    lead INDUSTRY

Principal Investigators

  • Christopher Centeno, MD · Centeno-Schultz Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2022-06-29
Completion
2022-06-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03618979 on ClinicalTrials.gov