Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients

NCT ID: NCT01053572

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-01-31

Brief 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.

Detailed 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.

Conditions

Low Back Pain

Study Design

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

Study Groups

Celestone

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

Group Type: ACTIVE_COMPARATOR

Adhesiolysis

Intervention Type: PROCEDURE

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

sodium chloride solution

Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone

Group Type: ACTIVE_COMPARATOR

Adhesiolysis

Intervention Type: PROCEDURE

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

sodium choride solution

Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;

Group Type: ACTIVE_COMPARATOR

Adhesiolysis

Intervention Type: PROCEDURE

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

Double substitutes

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

Group Type: ACTIVE_COMPARATOR

Adhesiolysis

Intervention Type: PROCEDURE

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

Interventions

Adhesiolysis

Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone

Intervention Type: PROCEDURE

Other Intervention Names

Adhesiolysis in post-surgery

Eligibility 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.

• 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, MD

Role: PRINCIPAL_INVESTIGATOR

PMC of Paducah

Locations

Pain Management Center of Paducah

Paducah, Kentucky, United States

Countries

United States

Other Identifiers

Protocol 23

Identifier Type: -

Identifier Source: org_study_id