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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Adhesiolysis

• Registration Number: NCT01053572
• Lead Sponsor: Pain Management Center of Paducah

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.

Study Timeline

• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-21
• Study Start: 2010-02
• Primary Completion: 2012-01
• Study Completion: 2014-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium chloride solution	Adhesiolysis	Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone
Double substitutes	Adhesiolysis	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
Celestone	Adhesiolysis	Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
sodium choride solution	Adhesiolysis	Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone;

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS), Oswestry Disability Index (ODI),	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

Secondary Outcome Measures

Name	Time	Method
Adverse event profile of 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.	Record side effects and any complications

Trial Locations

Locations (1)

Pain Management Center of Paducah; 🇺🇸 Paducah, Kentucky, United States