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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Caudal Epidural Injection; Procedure: percutaneous adhesiolysis

• Registration Number: NCT01053273
• Lead Sponsor: Pain Management Center of Paducah

Brief 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.

Detailed Description

Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.

This is a single-center study performed in an interventional pain management referral center in the United States.

The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.

Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value \< 0.05.

Study Timeline

• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Study Start: 2010-02
• Primary Completion: 2012-01
• Study Completion: 2014-01-27
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal epidural Injection	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
Percutaneous Adhesiolysis	percutaneous adhesiolysis	Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS), Oswestry Disability Index (ODI)	Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.	duration of significant pain relief, opioid intake, and return to work

Secondary Outcome Measures

Name	Time	Method
Adverse event profile of side effects and complications.	Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected.	List and look at all side effects and complications

Trial Locations

Locations (1)

Pain Management Center of Paducah; 🇺🇸 Paducah, Kentucky, United States