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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
Sponsor:
Information provided by (Responsible Party):
Chong Kim, West Virginia University

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Steroid
Epidural steroid injection
Drug: Epidural steroid
Experimental: Clonidine
Epidural clonidine injection
Drug: Clonidine



Primary Outcome Measures :
  1. Pain intensity measured on Visual analog scale (VAS) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Percentage of pain relief [ Time Frame: Day 0, 3 weeks, 3 months ]
  2. Level of disability (Oswestry Back Scale) [ Time Frame: 3 weeks, 3 months ]
  3. Adverse events [ Time Frame: Day 0, 3 weeks, 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
West Virginia University

Responsible Party: Chong Kim, Principal Investigator, West Virginia University
ClinicalTrials.gov Identifier: NCT02239627     History of Changes
Other Study ID Numbers: 140735818
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Clonidine
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action