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Completed

NCT Number: NCT01052571

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

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.

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Key information

Conditions

Low Back Pain Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatory Surgery Center

Paducah, Kentucky, 42001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbar transforaminal epidural injections

Procedure

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

Other names: Transforaminal Epidural

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pain Management Center of Paducah

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jan 20, 2010
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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