Epidural Clonidine for Lumbosacral Radiculopathy

NCT00588354 | Terminated Results

• 2 other identifiers: 06-0027381UL1RR024150-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Keywords

herniated disk; radiculopathy; clonidine; epidural; steroid; corticosteroid; nucleus pulposus; transforaminal

Outcome Measures

Primary Outcomes (1)

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

  11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).

  4 weeks

Secondary Outcomes (7)

• Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)

  2 weeks

• Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire

  2 weeks

• Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire

  4 weeks

• Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)

  2 weeks

• Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire

  4 weeks

Study Arms (2)

Clonidine

EXPERIMENTAL

Transforaminal epidural clonidine injection

Drug: Clonidine; Drug: Lidocaine HCl

Steroid

ACTIVE COMPARATOR

Transforaminal epidural steroid injection

Drug: Triamcinolone hexacetonide; Drug: Lidocaine HCl

Interventions

Clonidine DRUG

200 or 400 micrograms clonidine

Also known as: Catapres, Kapvay, Nexiclon

Clonidine

Triamcinolone hexacetonide DRUG

40 or 80 milligrams triamcinolone

Also known as: Aristocort, Kenacort, Tri-Nasal, Triaderm, Azmacort, Trilone, Volon A, Tristoject, Tricortone

Steroid

Lidocaine HCl DRUG

1 ml 2% lidocaine (20 mg/mL)

Also known as: Xylocaine, lignocaine

Clonidine; Steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Burgher AH, Hoelzer BC, Schroeder DR, Wilson GA, Huntoon MA. Transforaminal epidural clonidine versus corticosteroid for acute lumbosacral radiculopathy due to intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Mar 1;36(5):E293-300. doi: 10.1097/BRS.0b013e3181ddd597.

  PMID: 21192304 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy

Interventions

Clonidine; triamcinolone hexacetonide; Triamcinolone; Triamcinolone Acetonide; Lidocaine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed; did not measure analgesia during the expected analgesic peak of bolus administration, but 10 days after last injection; compared clonidine with an active control, rather than placebo.

Results Point of Contact

• Title: Dr. Marc A. Huntoon
• Organization: Mayo Clinic

huntoon.marc@mayo.edu

(507) 284-2511

Study Officials

• Marc A Huntoon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 8, 2008
• Study Start: October 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 11, 2012
• Results First Posted: January 11, 2012

Record last verified: 2011-12

Locations

US (1)