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

April 24, 2017 updated by: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Pain Management Center of Paducah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with history of lumbar surgery of at least 6 months duration in the past
  • Patients over the 18 years of age
  • Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration
  • Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements

Exclusion criteria:

  • Post surgery, central spinal stenosis, and facet joints as sole pain generators
  • Unstable or heavy opioid use
  • Uncontrolled psychiatric disorders
  • Uncontrolled medical illness
  • Any conditions that could interfere with the interpretation of the outcome assessments
  • Pregnant or lactating women
  • Patients with a history or potential for adverse reaction(s) to local anesthetics or steroid.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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: 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
Active Comparator: Percutaneous Adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
Procedure: percutaneous adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale (NRS), Oswestry Disability Index (ODI)
Time Frame: 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
Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event profile of side effects and complications.
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pain Management Center of Paducah

Investigators

  • Principal Investigator: Laxmaiah Manchikanti, Ambulatory Surgery Center, Paducah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 27, 2014

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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