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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053572
• Other study ID #: Protocol 23
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: April 24, 2017
• Start date: February 2010
• Est. completion date: January 2014

Study information

• Verified date: April 2017
• Source: Pain Management Center of Paducah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Pain Management Center of Paducah	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Pain Management Center of Paducah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.