A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections

Low Back Pain Clinical Trial

Official title:

Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053273
• Other study ID #: Protocol 27
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: April 24, 2017
• Start date: February 2010
• Est. completion date: January 27, 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

The purpose of this study is to:

• evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections.

• evaluate and compare the adverse event profile in all groups.

Description:

Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.

This is a single-center study performed in an interventional pain management referral center in the United States.

The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.

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: 120
• Est. completion date: January 27, 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with history of lumbar surgery of at least 6 months duration in the past

• Patients over the 18 years of age

• Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration

• Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements

Exclusion criteria:

• Post surgery, central spinal stenosis, and facet joints as sole pain generators

• Unstable or heavy opioid use

• 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 anesthetics or steroid.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Caudal Epidural Injection
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
• percutaneous adhesiolysis
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.

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.	List and look at all 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.