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

Pain Management Center of Paducah

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: percutaneous adhesiolysis; Procedure: Caudal Epidural Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01053273

Protocol 27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Caudal epidural Injection

Active Comparator group

Description:

Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution

Treatment:

Procedure: Caudal Epidural Injection

Percutaneous Adhesiolysis

Active Comparator group

Description:

Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone

Treatment:

Procedure: percutaneous adhesiolysis