Epidural Clonidine Versus Corticosteroid for Low Back Pain



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:September 2014
End Date:December 2016
Contact:Chong H Kim, MD
Email:kimc@wvuhealthcare.com
Phone:3045986216

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Prospective, Randomized, Double Blinded Comparison of the Analgesic Efficacy of Epidural Clonidine Versus Corticosteroid for Low Back Pain

Low back pain is a common condition, affecting majority of the adults in the United States
at some point in their lives. Fortunately, most resolve, even without treatment. However,
some suffer from continued or recurrent pain.

For those suffering from continued or recurrent low back pain, numerous treatment options
exist. One such option is an epidural injection, particularly when other non-surgical
treatment options have failed. An epidural injection is the placement of a needle into the
space around the spinal cord with the aid of a live X-Ray machine, followed by an injection
of various medications. Typically, the medication that is injected is a steroid, commonly
with the combination of local anesthetic medication. Epidural steroid injections, with or
without local anesthetic is part of the established standard of care in the United States
for those with continued or recurrent low back pain. The steroid is believed to reduce
inflammation and edema of the injured or irritated nerves. However, despite the routine use
of epidural steroids, the steroid itself is not without risks or side effects. Though rare,
the steroids have been associated with complications including osteoporosis, steroid induced
myopathy, cataracts and many others. In order to minimize the side effects associated with
epidural steroids, limiting the dose and frequency have been outlined.

Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food
and Drug Administration approved the medication for epidural use for cancer pain but studies
have shown effectiveness in non-cancer pain was well and is routinely used for various
conditions. There is growing evidence on the use of epidural clonidine for treatment of
pain, including low back pain.

This research will study and compare the effectiveness, if any, of clonidine compared to
steroid in an epidural injection for low back pain.


Inclusion Criteria:

1. Subject has clinical diagnosis of low back due to intervertebral disc disease, spinal
stenosis or herniated disc

2. Subject has average pain score (VAS) at least 5

3. Subject has persistent pain despite conservative care

4. Subjects has experienced pain for at least 1 month

5. 18 years of age or older when written informed consent is obtained

6. Signed IRB approved informed consent form

Exclusion Criteria:

1. Allergy to clonidine, dexamethasone, ropivicaine or lidocaine

2. Coagulopathy

3. Active Infection

4. Serious neurologic deficit

5. Subject is pregnant or planning on becoming pregnant during the course of the study

6. Subject is member of a vulnerable population

7. Investigator suspects substance abuse that might confound the study results

8. Subject has unresolved major issues of secondary gain (as determined by the
investigator)

9. Subject exhibits major psychiatric morbidity, untreated or refractory to treatment as
determined by the investigator

10. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that
would limit study candidate's ability to assess pain relief or complete study
assessments
We found this trial at
1
site
1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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Morgantown, WV
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