Official Title: “Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy”

Randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. Hypothesis is that clonidine will be as effective as steroid for this condition.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: clonidine
  • 200 or 400 micrograms clonidine and 1 milliliter 2% lidocaine, total volume of injectate 2 ml
• Drug: triamcinolone
  • 40 milligrams triamcinolone and 1 ml 2% lidocaine, total injectate volume of 2 ml; or 80 milligrams triamcinolone and 1 ml 2% lidocaine, total injectate volume of 3ml

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • transforaminal epidural clonidine injection plus local anesthetic
• Active Comparator: 2
  • transforaminal epidural steroid injection plus local anesthetic

Primary Measures

• Numerical Rating Scale (NRS) of pain
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Patient Global Impression of Change (PGIC)
  • Time Frame: 2 - 12 weeks
    Safety Issue?: No
• Oswestry Low Back Pain Disability Questionnaire
  • Time Frame: 2 - 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Residents 18 years or older of Olmsted or contiguous counties and identified as having an acute unilateral radicular syndrome of less than 3 months duration (leg pain>back, discogenic cause, one or more of the following:
• Positive SLR
• Myotomal weakness
• Dermatomal sensory loss) and with concordant
• Confirmatory findings on recent MRI or CT myelogram

Exclusion Criteria:

• History of recent spinal trauma
• Cauda equina syndrome
• Progressive neurological deficit
• Motor deficit
• Pathological or infectious etiology
• Involvement in workers' compensation claim
• History of adverse reaction to corticosteroids, local anesthetic or clonidine
• History of one or more corticosteroid injection(s) (equivalent to 40 mg of triamcinolone acetate) in the preceding 4 months
• Pregnant; OR
• Severe medical disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mayo Clinic

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00588354

Study ID Number: 06-002738

ClinicalTrials.gov Identifier: NCT00588354

Health Authority: United States: Institutional Review Board

Mayo Clinic Clinical Trials