Epidural Clonidine for Lumbosacral Radiculopathy

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Clonidine; Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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