Epidural Clonidine for Lumbosacral Radiculopathy

December 6, 2011 updated by: Mayo Clinic

Pilot Study of Transforaminal Epidural Injection of Clonidine for the Treatment of Acute Lumbosacral Radiculopathy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clonidine
Transforaminal epidural clonidine injection
Drug: Clonidine
200 or 400 micrograms clonidine
Other Names:
  • Catapres
  • Kapvay
  • Nexiclon
Drug: Lidocaine HCl
1 ml 2% lidocaine (20 mg/mL)
Other Names:
  • Xylocaine
  • lignocaine
Active Comparator: Steroid
Transforaminal epidural steroid injection
Drug: Lidocaine HCl
1 ml 2% lidocaine (20 mg/mL)
Other Names:
  • Xylocaine
  • lignocaine
Drug: Triamcinolone hexacetonide
40 or 80 milligrams triamcinolone
Other Names:
  • Volon A
  • Kenacort
  • Azmacort
  • Aristocort
  • Tri-Nasal
  • Triaderm
  • Trilone
  • Tristoject
  • Tricortone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
Time Frame: 4 weeks
11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)
Time Frame: 2 weeks
11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).
2 weeks
Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire
Time Frame: 2 weeks
This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.
2 weeks
Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire
Time Frame: 4 weeks
This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.
4 weeks
Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)
Time Frame: 2 weeks
This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.
2 weeks
Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire
Time Frame: 4 weeks
This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.
4 weeks
Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
Time Frame: 2 weeks
The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.
2 weeks
Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)
Time Frame: 4 weeks
The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: Marc A Huntoon, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-002738
  • 1UL1RR024150-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Clinical Trials on Clonidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe