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.
|
