Overview

This trial is active, not recruiting.

Condition low back pain
Treatments caudal epidural injection, percutaneous adhesiolysis
Sponsor Pain Management Center of Paducah
Start date February 2010
End date January 2012
Trial size 120 participants
Trial identifier NCT01053273, Protocol 27

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Active Comparator)
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
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)
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
percutaneous adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.

Primary Outcomes

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

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial
Principal investigator Laxmaiah Manchikanti
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Pain Management Center of Paducah.