Epidural Clonidine for Lumbosacral Radiculopathy

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

This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.

Patients with approximately 3 months of low back pain and leg pain due to intervertebral disc herniation were randomized to transforaminal epidural injections of 2% lidocaine and either clonidine (200 or 400 micrograms) or triamcinolone (40 mg) (corticosteroid). Patients received one to three injections administered at about 2 weeks apart. Patients, investigators, and study coordinators were blinded to the treatment. The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. The hypothesis was that clonidine will be as effective as steroid for this condition.

Intervention(s) in this Clinical Trial

• Drug: Clonidine
  • 200 or 400 micrograms clonidine
• Drug: Triamcinolone hexacetonide
  • 40 or 80 milligrams triamcinolone
• Drug: Lidocaine HCl
  • 1 ml 2% lidocaine (20 mg/mL)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Clonidine
  • Transforaminal epidural clonidine injection
• Active Comparator: Steroid
  • Transforaminal epidural steroid injection

Primary Measures

• Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
  • Time Frame: 2 weeks
    Safety Issue?: No
• Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire
  • Time Frame: 2 weeks
    Safety Issue?: No
• Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire
  • Time Frame: 4 weeks
    Safety Issue?: No
• Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)
  • Time Frame: 2 weeks
    Safety Issue?: No
• Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire
  • Time Frame: 4 weeks
    Safety Issue?: No
• Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
  • Time Frame: 2 weeks
    Safety Issue?: No
• Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
  • Time Frame: 4 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 Straight Leg Raise (SLR) test
• 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 (This is a serious neurologic condition in which there is acute loss of function of the lumbar plexus, neurologic elements of the spinal canal below the termination of the spinal cord.)
• 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
• 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 Investigator: Mayo Clinic Other

Overall Clinical Trial Officials and Contacts

Marc A Huntoon, MD Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on February 08, 2012

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