Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2010 |
| End Date: | August 2014 |
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
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.
patients randomized to the local anesthetic group who did not receive steroids.
To evaluate and compare the adverse event profile in all patients.
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.
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.
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
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