Epidural Clonidine for Lumbosacral Radiculopathy
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lumbosacral Radiculopathy Due to Herniated Disk
Intervention: clonidine (Drug); triamcinolone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mayo Clinic Overall contact:
Marc A Huntoon, MD, Phone: (507) 538-3270
Summary
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.
Clinical Details
Official title: Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Numerical Rating Scale (NRS) of pain
Secondary outcome: Patient Global Impression of Change (PGIC)Oswestry Low Back Pain Disability Questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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
Locations and Contacts
Marc A Huntoon, MD, Phone: (507) 538-3270
Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Abram H Burgher, MD, Sub-Investigator
Marc A Huntoon, MD, Principal Investigator
Additional Information
Mayo Clinic Clinical Trials
Starting date: October 2006
Ending date: November 2008
Last updated: January 7, 2008
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