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NCT Number: NCT00364572

Efficacy of Epidural Etanercept in the Treatment of Sciatica

Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior. Open-label studies in humans have shown both etanercept and infliximab provide excellent, long-term relief in patients with acute radiculopathy from herniated disc. However, a recent placebo-controlled study failed to demonstrate any significant difference from placebo. The investigators have already established the safety of neuraxial etanercept in a trial that has just been completed (not yet published). The objective of this study is to determine whether small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for LBP caused by nerve root irritation (i.e., radiculopathy).

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Key information

Conditions

Sciatica Back Pain Low Back Pain Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

About this study

As per the wishes of the Dept. of the Army and Walter Reed Army Medical Center Dept. of Clinical Investigation, patients will be randomized in a 3:1 ratio to receive 2 transforaminal epidural etanercept or saline injections at 2-week intervals. Both patients and physicians will be blinded as to the injectate and treatment group. There will be 3 study groups. Group I will receive either 2 mg of etanercept or saline per injection. Group II will receive either 4 mg of etanercept or saline per injection. Group III will receive either 6 mg of etanercept or saline per injection. In each group there will be 8 patients: 6 who receive etanercept and 2 who receive saline. As per a previous study we just completed, etanercept doses will not be escalated until all 6 patients have completed their 1-month follow-up visits without any evidence of toxicity or complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic low back pain of radicular origin of > 2 months but < 1 year duration.
  • Failure of conservative therapy to include physical and pharmacotherapy.
  • MRI evidence of a herniated disc corresponding to the patient's radicular symptoms.
  • Normal white blood cell count (drawn in 1 blood vial).

Exclusion criteria

  • Uncontrolled coagulopathy.
  • Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists.
  • Allergy to contrast dye.
  • Unstable medical condition (e.g., unstable angina or congestive heart failure).
  • Rheumatoid arthritis, Crohn's disease or spondylarthropathy.
  • Unstable neurological condition (e.g., multiple sclerosis)
  • Systemic infection
  • Age < 18 or > 70 years.

Treatment and study plan

epidural injection of etanercept

Drug

2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg

placebo (control procedure)

Drug

Two injections of epidural saline 2 weeks apart

Primary outcomes

  1. Visual analogue scale pain score, Oswestry disability index, medication intake

    Time frame: 7 months

Secondary outcomes

  1. Global perceived effect, white blood cell count

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Walter Reed Army Medical Center

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2006
Registry last updated
Jan 22, 2009

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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