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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT01052571
First received: January 18, 2010
Last updated: March 21, 2012
Last verified: March 2012
History of Changes

January 18, 2010
March 21, 2012
February 2010
January 2012   (final data collection date for primary outcome measure)
Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work [ Time Frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01052571 on ClinicalTrials.gov Archive Site
Adverse event profile of side effects and complications. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Low Back Pain
Drug: lumbar transforaminal epidural injections
with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level
Other Name: 1% Xylocaine, 0.25% bupivacaine, non-particulate Celestone.
  • Active Comparator: Without Steroids
    Group I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25%
    Intervention: Drug: lumbar transforaminal epidural injections
  • Active Comparator: steroids
    Group II patients will receive transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level
    Intervention: Drug: lumbar transforaminal epidural injections
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
January 2014
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01052571
Protocol 24
Yes
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Pain Management Center of Paducah
Not Provided
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center, Paducah
Pain Management Center of Paducah
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP