MedTrace Logo

Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

NCT01850771 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-06-03

No results posted yet for this study

Summary

The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months.

Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

Conditions

  • Radiculopathy
  • Herniated Disc
  • Disc Degeneration

Interventions

PROCEDURE

Regenexx PL-Disc

Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.

PROCEDURE

Steroid Epidural

Injection into the epidural space under image guidance of 3 mg of betamethasone.

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
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01850771 on ClinicalTrials.gov