Epidural Clonidine for Lumbosacral Radiculopathy

Study Overview
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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.

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.

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

Conditions
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Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Intervention / Treatment
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* Drug: Clonidine
* Drug: Triamcinolone hexacetonide
* Drug: Lidocaine HCl


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clonidine<br>Transforaminal epidural clonidine injection | Drug: Clonidine<br>* 200 or 400 micrograms clonidine<br>* Other names: Nexiclon;Drug: Lidocaine HCl<br>* 1 ml 2% lidocaine (20 mg/mL)<br>* Other names: lignocaine;|
| Active Comparator: Steroid<br>Transforaminal epidural steroid injection | Drug: Triamcinolone hexacetonide<br>* 40 or 80 milligrams triamcinolone<br>* Other names: Tricortone;Drug: Lidocaine HCl<br>* 1 ml 2% lidocaine (20 mg/mL)<br>* Other names: lignocaine;|

What is the study measuring?
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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) | 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) | 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 | 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 | 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) | 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 | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herniated disk, radiculopathy, clonidine, epidural, steroid, corticosteroid, nucleus pulposus, transforaminal