Epidural Clonidine for Lumbosacral Radiculopathy

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clonidine

Triamcinolone hexacetonide

Lidocaine HCl

About this trial

This is an interventional treatment trial for Lumbar and Other Intervertebral Disc Disorders With Radiculopathy focused on measuring herniated disk, radiculopathy, clonidine, epidural, steroid, corticosteroid, nucleus pulposus, transforaminal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clonidine

Steroid

Arm Description

Transforaminal epidural clonidine injection

Transforaminal epidural steroid injection

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain Intensity Score at 2 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).

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

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.

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

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.

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

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.

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

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.

Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

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.

Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

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.

Full Information

NCT ID

NCT00588354

First Posted

December 26, 2007

Last Updated

December 6, 2011

Sponsor

Mayo Clinic

Collaborators

National Center for Research Resources (NCRR)

1. Study Identification

Unique Protocol Identification Number

NCT00588354

Brief Title

Epidural Clonidine for Lumbosacral Radiculopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Terminated

Why Stopped

Targeted enrollment was not reached.

Study Start Date

October 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clonidine

Arm Type

Experimental

Arm Description

Transforaminal epidural clonidine injection

Arm Title

Steroid

Arm Type

Active Comparator

Arm Description

Transforaminal epidural steroid injection

Intervention Type

Drug

Intervention Name(s)

Clonidine

Other Intervention Name(s)

Catapres, Kapvay, Nexiclon

Intervention Description

200 or 400 micrograms clonidine

Intervention Type

Drug

Intervention Name(s)

Triamcinolone hexacetonide

Other Intervention Name(s)

Aristocort, Kenacort, Tri-Nasal, Triaderm, Azmacort, Trilone, Volon A, Tristoject, Tricortone

Intervention Description

40 or 80 milligrams triamcinolone

Intervention Type

Drug

Intervention Name(s)

Lidocaine HCl

Other Intervention Name(s)

Xylocaine, lignocaine

Intervention Description

1 ml 2% lidocaine (20 mg/mL)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 weeks

Title

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

Description

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.

Time Frame

2 weeks

Title

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

Description

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.

Time Frame

4 weeks

Title

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

Description

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.

Time Frame

2 weeks

Title

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

Description

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.

Time Frame

4 weeks

Title

Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

Description

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.

Time Frame

2 weeks

Title

Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)

Description

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.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc A Huntoon, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21192304

Citation

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.

Results Reference

result

Links:

URL

http://clinicaltrials.mayo.edu

Description

Mayo Clinic Clinical Trials

Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial