Clinical trial NCT02239627: Epidural Clonidine Versus Corticosteroid for Low Back Pain
Official title: Prospective, Randomized, Double Blinded Comparison of the Analgesic Efficacy of Epidural Clonidine Versus Corticosteroid for Low Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Back Pain
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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

Primary outcomes:
measure: Pain Intensity Measured on Visual Analog Scale (VAS)
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Pain Relief
timeFrame: Day 0, 3 weeks, 3 months
measure: Level of Disability (Oswestry Back Scale)
timeFrame: 3 weeks, 3 months
measure: Adverse Events
timeFrame: Day 0, 3 weeks, 3 months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
Study officials:
References: