Clinical trial NCT01053273: A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections
Official title: Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Post lumbar laminectomy syndrome
Lumbar spinal stenosis
Local anesthetic steroid
Lumbar transforaminal epidural injection
Percutaneous epidural adhesiolysis
Caudal epidural injection
Lead sponsor: Pain Management Center of Paducah
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric rating scale (NRS), Oswestry Disability Index (ODI)
timeFrame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
Secondary outcomes:
measure: Adverse event profile of side effects and complications.
timeFrame: 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.
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Pain Management Center of Paducah
state: Kentucky
Study officials:
affiliation: Ambulatory Surgery Center, Paducah
name: Laxmaiah Manchikanti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010 Mar-Apr;13(2):E91-E110.