Overview

This trial is active, not recruiting.

Condition low back pain
Treatment adhesiolysis
Sponsor Pain Management Center of Paducah
Start date February 2010
End date January 2012
Trial size 240 participants
Trial identifier NCT01053572, Protocol 23

Summary

To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome.

To 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 adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
adhesiolysis Adhesiolysis in post-surgery
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
(Active Comparator)
Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
adhesiolysis Adhesiolysis in post-surgery
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
(Active Comparator)
Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;
adhesiolysis Adhesiolysis in post-surgery
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
(Active Comparator)
Group IV will receive adhesiolysis, local anesthetic, and 0.9% sodium chloride solution to substitute for the 10% hypertonic sodium chloride, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
adhesiolysis Adhesiolysis in post-surgery
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

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: Inclusion criteria: - History of lumbar surgery of at least 6 months duration in the past - Patients over the age of 18 years - Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration (post-surgery) - Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements. Exclusion criteria: - Facet joints, uncontrollable as sole pain generators - Unstable or heavy opioid use (400 mg of morphine equivalents daily) - 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 anesthetic, steroids, or hypertonic sodium chloride solution.

Additional Information

Official title Evaluation of the Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients: A Prospective, Randomized, Double-Blind, Equivalence, Controlled Trial of Percutaneous Lumbar Adhesiolysis
Principal investigator Laxmaiah Manchikanti, MD
Description Recruitment is indicated in patients with chronic low back pain and lower extremity pain secondary to post lumbar laminectomy syndrome, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections. This is a single-center, prospective, randomized, double-blind, equivalence, controlled trial performed in an interventional pain management referral center in the United States. The study involves 240 patients studied in 4 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding. 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.