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

NCT ID: NCT01053273

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-01-27

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Caudal Epidural Injection

Intervention Type: PROCEDURE

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

Percutaneous Adhesiolysis

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

Group Type: ACTIVE_COMPARATOR

percutaneous adhesiolysis

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

percutaneous adhesiolysis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pain Management Center of Paducah

OTHER

Sponsor Role: lead

Responsible Party

Laxmaiah Manchikanti, MD

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laxmaiah Manchikanti

Role: PRINCIPAL_INVESTIGATOR

Ambulatory Surgery Center, Paducah

Locations

Pain Management Center of Paducah

Paducah, Kentucky, United States

Countries

United States

References

Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010 Mar-Apr;13(2):E91-E110.

Reference Type: DERIVED

PMID: 20309389 (View on PubMed)

Other Identifiers

Protocol 27

Identifier Type: -

Identifier Source: org_study_id