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Trial for Treating Painful Degenerative Disc Disease

NCT05287867 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease

Interventions

BIOLOGICAL

Platelet-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.

OTHER

Sham 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.

Sponsors & Collaborators

  • Regenexx, LLC

    lead INDUSTRY

Principal Investigators

  • Christopher Centeno, MD · Centeno-Schultz Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT05287867 on ClinicalTrials.gov