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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Adhesiolysis

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Pain Management Center of Paducah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Celestone; Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone	Procedure: Adhesiolysis; Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone; Other Names: Adhesiolysis in post-surgery
Active Comparator: 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	Procedure: Adhesiolysis; Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone; Other Names: Adhesiolysis in post-surgery
Active Comparator: 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;	Procedure: Adhesiolysis; Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone; Other Names: Adhesiolysis in post-surgery
Active Comparator: 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	Procedure: Adhesiolysis; Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone; Other Names: Adhesiolysis in post-surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event profile of side effects and complications.	Record side effects and any 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.

Collaborators and Investigators

• Sponsor: Pain Management Center of Paducah
• Investigators: Principal Investigator: Laxmaiah Manchikanti, MD, PMC of Paducah

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 19, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Chronic low back pain; Lower extremity pain; Local anesthetic; Steroid; Post lumbar laminectomy syndrome; Percutaneous lumbar adhesiolysis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Protocol 23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No