Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01052571

Enrollment

120

Registered

2010-01-20

Start date

2010-02-28

Completion date

2014-08-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Chronic low back pain, Lumbar disc herniation, Lower extremity pain, Lumbar radiculitis, Local anesthetic, Steroid, Lumbar transforaminal epidural injection

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.

Interventions

PROCEDURElumbar transforaminal epidural injections

with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse event profile of 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026