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Title: The Effect of Cranial Electrotherapy Stimulation (CES) on Pain Associated with Fibromyalgia

Authors:   Randall C. Cork, M.D., Ph.D., Department of Anesthesiology, LSU Health Sciences Center, Shreveport, LA Patrick Wood, M.D., Department of Anesthesiology, LSU Health Sciences Center , Shreveport, LA Norbert Ming M.D., Department of Anesthesiology, LSU Health Sciences Center, Shreveport, LA Clifton Shepherd M.D., Department of Anesthesiology, LSU Health Sciences Center, Shreveport, LA James Eddy M.D., Department of Anesthesiology, LSU Health Sciences Center, Shreveport, LA Larry Price Ph.D., Texas State University, San Marcos, TX

Abstract

Subjective pain intensity was the primary measured variable in a double-blind crossover study examining the effect of cranial electrotherapy stimulation (CES) on the pain associated with fibromyalgia. Initially, 39 patients were randomly allocated to CES and 35 patients were allocated to a sham group. Measurements taken at baseline and after three weeks included pain intensity, McGill Pain Score, tenderpoint score, profile of mood states, and Oswestry Score. Three weeks after crossover, measurements were repeated. Significant CES effects were identified, revealing an improvement in pain intensity, McGill Score, tenderpoint score, and profile of mood states (p<0.05). However, no significant effect was observed on Oswestry Score, which is a score identifying functional effects of pain. This study reveals that CES could play a significant role in the treatment of pain associated with fibromyalgia; however, the long-term effects on disability remain to be studied.

Supported by a grant from the Department of Anesthesiology, LSU Health Sciences Center. No financial support was received from the makers of the Alpha-Stim®; however, Electromedical Products International, Inc. did loan the authors the Alpha-Stim® units necessary to do the study.

Introduction

In a nod to Lewis Carroll, Arthur Weinstein has referred to fibromyalgia as not so much “a grin without a cat,” but a “frown without a cat.” 1 In fact, so little is known about fibromyalgia that many indignant academicians question its existence. Unfortunately for us clinicians, the parade of patients presenting daily at our offices must be addressed. We have to do something. As a result, we are constantly looking for something new to do.

Cranial electrotherapy stimulation (CES) may be that something. It is a form of electrical stimulation that has already been approved by the FDA as a drug-free treatment for anxiety, depression, and insomnia, all of which have been identified as common comorbidities in patients with fibromyalgia. CES typically involves the passage of microcurrent levels of electrical stimulation across the head for from 20 minutes to an hour daily for a few days to a few weeks. Kirsch has published a review of over 150 human and animal studies regarding CES. 2 A recent series of meta-analyses on the effectiveness of CES has also been recently published. 3

The purpose of this clinical study was to examine the effect of CES on a group of patients with a diagnosis of fibromyalgia. The primary variable was pain intensity, as measured by the patient using a numerical scale of 0 (no pain) to 5 (worst pain possible). Secondary measurements included tenderpoint score, McGill Pain Score, Profile of Mood States (POMS), and Oswestry Score.

Methods

After approval from the LSU Health Sciences Center—Shreveport IRB, patients 22-75 years of age presenting at the LSU Pain Clinic with a diagnosis of fibromyalgia were randomly assigned to either a Sham Group or a Cranial Electrotherapy Stimulation (CES) Group. The diagnosis of fibromyalgia was verified using the criteria set forth by the American College of Rheumatology. 4 Exclusion criteria included pregnancy and presence of implanted pacemakers, pumps, or stimulators, as well as the presence of superficial or internal ear infections. No change was made in the medical management of the patient during the study.

All patients were given a CES device that would provide either subsensation treatment or sham treatment. The Alpha-Stim CES device was used (Electromedical Products International, Inc., Mineral Wells, TX, http://www.alpha-stim.com/). Each device was preset to provide 1 hour of 100 µA, modified square-wave biphasic stimulation on a 50% duty cycle at 0.5 Hz, and to automatically turn off at the end of one hour. All treatment was given via electrodes clipped to the ear lobes (Figure 1). Location of electrodes on the ear lobes is illustrated in Figure 2. Sham treatment was provided by identical ear clip electrodes that did not pass current. All staff, the physicians, and the patient were blind to the treatment conditions. At the end of three weeks, the CES Group was unblinded, and the Sham Group was given the option to receive active therapy for an additional three weeks.

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The Internet Journal of Anesthesiology • Volume 8, Number 2 • 2004

 

©2006 by
 

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The Effect of Cranial Electrotherapy Stimulation (CES) on Pain Associated with Fibromyalgia.