Epidural Clonidine Versus Corticosteroid for Low Back Pain
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|ClinicalTrials.gov Identifier: NCT02239627|
Recruitment Status : Terminated (based on interim anaylsis)
First Posted : September 15, 2014
Last Update Posted : June 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Back Pain||Drug: Epidural steroid Drug: Clonidine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Prospective, Randomized, Double Blinded Comparison of the Analgesic Efficacy of Epidural Clonidine Versus Corticosteroid for Low Back Pain|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Steroid
Epidural steroid injection
Drug: Epidural steroid
Epidural clonidine injection
- Pain intensity measured on Visual analog scale (VAS) [ Time Frame: 3 months ]
- Percentage of pain relief [ Time Frame: Day 0, 3 weeks, 3 months ]
- Level of disability (Oswestry Back Scale) [ Time Frame: 3 weeks, 3 months ]
- Adverse events [ Time Frame: Day 0, 3 weeks, 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239627
|United States, West Virginia|
|West Virginia University Hospitals|
|Morgantown, West Virginia, United States, 26505|