Epidural Clonidine Versus Corticosteroid for Low Back Pain

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.

Study Overview

• Status: Terminated
• Conditions: Back Pain
• Intervention / Treatment: Drug: Clonidine; Drug: Epidural steroid

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Institutional Review Board (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Steroid; Epidural steroid injection	Drug: Epidural steroid
Experimental: Clonidine; Epidural clonidine injection	Drug: Clonidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain Intensity Measured on Visual Analog Scale (VAS)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Pain Relief	Day 0, 3 weeks, 3 months
Level of Disability (Oswestry Back Scale)	3 weeks, 3 months
Adverse Events	Day 0, 3 weeks, 3 months

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 12, 2014
• First Posted (Estimate): September 15, 2014

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Clonidine
• Other Study ID Numbers: 1407358518