Epidural Clonidine for Lumbosacral Radiculopathy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clonidine

Transforaminal epidural clonidine injection

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

200 or 400 micrograms clonidine

Lidocaine HCl

Intervention Type DRUG

1 ml 2% lidocaine (20 mg/mL)

Steroid

Transforaminal epidural steroid injection

Group Type ACTIVE_COMPARATOR

Triamcinolone hexacetonide

Intervention Type DRUG

40 or 80 milligrams triamcinolone

Lidocaine HCl

Intervention Type DRUG

1 ml 2% lidocaine (20 mg/mL)

Interventions

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Clonidine

200 or 400 micrograms clonidine

Intervention Type DRUG

Triamcinolone hexacetonide

40 or 80 milligrams triamcinolone

Intervention Type DRUG

Lidocaine HCl

1 ml 2% lidocaine (20 mg/mL)

Intervention Type DRUG

Other Intervention Names

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Catapres Kapvay Nexiclon Aristocort Kenacort Tri-Nasal Triaderm Azmacort Trilone Volon A Tristoject Tricortone Xylocaine lignocaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes