TerminatedNot Applicable

Epidural Clonidine for Lumbosacral Radiculopathy

Stopped: Targeted enrollment was not reached.

United States26 participantsStarted 2006-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

Timeframe: 4 weeks

Trial details

NCT IDNCT00588354

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-02

Results submitted2011-06-03

View on ClinicalTrials.gov More Lumbar and Other Intervertebral Disc Disorders With Radiculopathy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.