Clinical trial NCT01052571: Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis
Official title: A Randomized, Prospective, Double-Blind, Equivalence, Controlled Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis With or Without Steroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Chronic low back pain
Lumbar disc herniation
Lower extremity pain
Lumbar radiculitis
Local anesthetic
Steroid
Lumbar transforaminal epidural injection
Lead sponsor: Pain Management Center of Paducah
Sponsor class: OTHER
First posted: 2010-01-20
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: To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

To evaluate and compare the adverse event profile in all patients.

Detailed description: Recruitment is indicated in patients with chronic low back and lower extremity pain secondary to lumbar disc herniation and/or lumbar radiculitis of at least 6-months duration, non-responsive to conservative management with NSAIDs, physical therapy, chiropractic treatment, and exercises.

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

The study involves 120 patients studied in 2 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.

Eligibility criteria: Inclusion criteria:

* Patients with disc herniation or radiculitis
* Patients who are 18 years of age
* Patients with a history of chronic function-limiting low back and 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:

* Previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation
* Uncontrollable or unstable opioid use
* Uncontrolled psychiatric disorders
* Uncontrolled medical illness either acute or chronic
* Any conditions that could interfere with the interpretation of the outcome assessments
* Pregnant or lactating women

Primary outcomes:
measure: Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work
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: Ambulatory Surgery Center
state: Kentucky
Study officials:
affiliation: Ambulatory Surgery Center, Paducah
name: Laxmaiah Manchikanti, MD
role: PRINCIPAL_INVESTIGATOR
References: