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extended to other clinical groups
such as patients with closed head injuries (9) and children and adults
with attention deficit disorder (10). Electroencephalographic studies
in patients with insomnia have found CES effective in reducing sleep
onset time, number of awakenings during the night, time spent in stage
IV (delta) sleep, and patient report of feeling rested upon awakening
(11). Most recently, it has been noted that CES is associated with an
increase in insulin-like growth factor-1 (IGF-1) levels in older
female patients (12).
Perhaps because of its use in the treatment of various stress
disorders, CES is finding an ever-greater use in the treatment of
several pain syndromes (13). Many clinicians believe that the pain
threshold tends to lower in response to stress and rise as stress is
reduced. Schuster states, "Patients' psychological states influence
their perceptions of pain; anxiety can decrease patients' pain
thresholds. In-creased anxiety . . . can increase pain" (14). Bennett
agrees, saying, "there is . . . overwhelming evidence that psychologic
factors do affect perception of pain. . ." (15).
The fibromyalgia literature has documented problems in fibromyalgia
patients that involve many of the areas in which CES has been found
effective. One reviewer found studies in which insomnia was a major
contributing problem in fibromyalgia (16), and Wolfe found that more
than 75% of patients with fibromyalgia experience a nonrestorative
sleep pattern (17). Another reviewer noted that in addition to sleep
problems, the fibromyalgia patients also suffered from marked anxiety
and depression (18). Another study has found consistently low levels
of IGF-1 levels in fibromyalgia patients when compared with
nonfibromyalgia controls (19).
Although we have treated a large number of fibromyalgia patients |
in our clinic over the years, we only recently
became aware of
the CES research findings. Once this research was brought to our
attention, we completed a successful open clinical trial of CES
treatment of our fibromyalgia patients. After that, we decided to
perform a double-blind, placebo-controlled study to see if these
effects were attributable to the CES treatment or to placebo effect
alone.
PATIENTS AND METHODS:
After approval of the study protocol by the Investigational Re-view
Board of the Robert Wood Johnson Medical School, 60 patients from our
large fibromyalgia practice signed volunteer consent forms to
participate in the study. The first author (ASL), a physician, had
previously diagnosed them as having fibromyalgia, using the criteria
set forth by the American College of Rheumatology (20). The subjects'
age range was 23 to 82 years (mean, 50); there were two men and 58
women including two African Americans and one Asian American. They had
suffered with fibromyalgia from 1 to 40 years, with an average of 11
years. No change was made in the medical treatment regimen then
underway of any subject in the study.
The subjects were randomly as-signed into three separate groups by an
office secretary who drew their names, which were on separate, sealed
slips of paper in a container. Groups I and II were as-signed to CES
devices that would provide either subsensation treatment or sham
treatment. Group III served as wait-in-line placebo controls, to
control for any placebo effect experienced by the sham-treated group.
The Alpha-Stim CES device was used (Electromedical Products
International, Inc., Mineral Wells, TX). Each device was preset to
provide 1 hour of 100-ľA, modified square-wave biphasic stimulation on
a 50% duty cycle at 0.5 Hz, and to automatically turn off at the end
of the hour. To prevent the subjects from increasing
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the current from the 100-ľA presetting, once the
current level had been set, the current setting dial was removed from
the device and the space that it occupied was permanently sealed. All
treatment was given via electrodes clipped to the ear lobes. Sham
treatment was provided by identical ear clip electrodes that did not
pass current. All ear clip electrodes had a number etched on them,
identifying each as real or sham treating, and the code was kept in a
sealed envelope away from the study site.
All subjects, the staff, the examining physician, and the
psychometrician remained blind to the treatment conditions. After the
study, the staff opened the code envelope and separated the patient
evaluation forms into treatment, sham treatment, or placebo control
groups. The statistician who evaluated the final study results
remained blind to the treatment conditions, working from three
identical groups of study data during the data analysis. The above
procedures rendered the study essentially quadruple-blind.
Just prior to beginning the treatment phase of the study, the study
physician pretested all patients on nine bilateral tender points and
three bilateral sham tender points. The sham points were on the
biceps, the abdomen, and the gastrocnemius. Any scores obtained at
these points were subtracted from the total tender point score. The
patients then completed self-ratings of overall pain, quality of
sleep, feeling of well-being, and quality of life, all on 10-point
self-rating forms that were provided. Finally, the patients completed
the Profile of Mood States (POMS) (Educational and Industrial Testing
Service, San Diego, CA), a standardized paper and pencil
psychological test measuring the following mood factors:
tension/anxiety, depression/dejection, anger/hostility, energy/vigor,
fatigue/inertia, and confusion/bewilderment. An overall total mood
disturbance
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Cranial
Electrotherapy Stimulation