RecruitingNot ApplicableNCT05287867

Trial for Treating Painful Degenerative Disc Disease

A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease


Sponsor

Regenexx, LLC

Enrollment

42 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.


Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) and Sham procedure for people with degenerative disc disease. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 25 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPlatelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)

Approx 161-420cc autologous blood is drawn and processed into PPP, PRP, and PL, amount dependent on condition. Using sterile technique with patient sedated, US or x-ray is used to guide needles bilaterally into multifidus, specifically LM, TF, IAF. Once the lamina is reached the physician injects 2.5 cc of PPP into the multifidus muscle on one side and then repeat this on the opposite side for each level. The physician guides a needle into the supraneural transforaminal space to perform an epidural injection with 2cc of 4x 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. Any tendon insertion areas will be injected using ultrasound guidance with platelet lysate dextrose. The supraspinous/interspinous, SI ligaments at the involved degenerative levels will be injected with 4x PL/12.5% dextrose/0.125% ropivacaine. If L5/S1 is involved, the iliolumbar ligaments will also be injected.

OTHERSham procedure

Approximately 161-420 cc of autologous blood is drawn to maintain patient blinding. While lying prone, the patient's back will be exposed and prepped sterilely. Provider puts patient in conscious sedation and several needles are placed into the low back. The provider inserts needle into the facet joint and then removes. Then inserts the needle midline to ligament and removes (1 needle per level) mimicking normal needle placement, but not injecting anything.


Locations(2)

Centeno-Schultz Clinic

Broomfield, Colorado, United States

Centeno-Schultz Clinic

Lone Tree, Colorado, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05287867


Related Trials