MedTrace Logo

A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections

NCT01053273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-04-25

No results posted yet for this study

Summary

The purpose of this study is to:

* evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections.
* evaluate and compare the adverse event profile in all groups.

Conditions

  • Low Back Pain

Interventions

PROCEDURE

Caudal Epidural Injection

Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution

PROCEDURE

percutaneous adhesiolysis

Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.

Sponsors & Collaborators

  • Pain Management Center of Paducah

    lead OTHER

Principal Investigators

  • Laxmaiah Manchikanti · Ambulatory Surgery Center, Paducah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-01-31
Completion
2014-01-27

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 NCT01053273 on ClinicalTrials.gov