ABSTRACT:
This study conducted at the Integrated Medical Centers of California,
La Jolla, compared Alpha-Stim CES alone (N=20) to Alpha-Stim CES and
chiropractic treatment (N=40). Sixty patients diagnosed with
fibromyalgia between the ages of 25 and 57 (mean of 45) completed
informed consent, and were then evaluated on the Profile of Mood
States along with self-ratings of their pain level, quality of sleep,
feeling of well being, and quality of life, all on 10-point scales.
Tender points were also evaluated. Patients were treated at 0.5 Hz,
one hour per day for three weeks via ear clip electrodes. They were
able to adjust the current to a comfortable level between 0 and 500
microamperes, with the majority choosing between 100 and 300
microamperes. No attempt was made to adjust medications.
One of the CES patients and 3 of the CES plus chiropractic patients
dropped out leaving two groups of 19 and 37 patients. The patients who
received CES alone achieved an average of 26% improvement in their
pain levels, while the combined therapy group achieved 34%
improvement. The combined therapy group exhibited an improvement of
32% in their tender point evaluations. The combined therapy group also
fared better in 5 of the psychological measures. On the overall sleep
self-rating scales, 87% of the patients entering the study rated their
sleep as moderate to very poor. At the end of the study, 80% rated
their sleep as moderate to excellent, an almost mirror image turn
around in their quality of sleep. The authors concluded that CES is a
valuable adjunct to chiropractic management of fibromyalgia patients.
No negative side effects were reported.
Key words: Fibromyalgia, CES, Electrotherapy, Microcurrent,
Chiropractic
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The diagnosis of fibromyalgia has
been on the rise in the past 15-to-20 years. Its incidence was
rated as high as 4.8% of the population as of 1995. and is still
climbing.1 Numerous drug trials with the patients have been
reported, with one reviewer noting that the pain reduction found in 34
such medication studies has averaged no more than 28%. and the
medications have often been accompanied by sometimes serious side
effects, in up to 20% of the study patients.2
Because it is known that psychological stress tends to augment the
pain message3,4, we at the integrated Medical Centers of
California, La Jolla, decided to do a clinical trial of cranial
electrotherapy stimulation (CES) alone, compared with a group of
patients who received CES plus physical medicine.
CES is an FDA accepted, non-drug treatment for depression, anxiety and
insomnia. all stress producing dysfunctions.5 In an
earlier study reported at an international conference in 1999, CES had
been shown to reduce the perception of pain at the tender points
significantly.6
We decided to attempt a replication of earlier CES treatment findings
in fibromyalgia patients, and compare them with a second group of
patients who would receive indicated chiropractic care along with CES
therapy. This would allow us to evaluate any effect of the combination
treatment on fibromyalgia pain.
Method
Sixty patients with a prior diagnosis of fibromyalgia signed voluntary
consent forms to be in the study. Every third patient was assigned to
receive CES alone, while the others were to receive both CES and
chiropractic treatment. All patents were between the ages of 25 |
and 57 (mean 45) Five were male, and three were Latin
American.
All patients were pre-tested on the Profile of Mood States (POMS), a
standardized psychological test. In addition, all were asked to rate
their overall pain level, their quality of sleep, their feeling of
well being and their quality of life. on 10-point scale. Finally,
their pain level on nine bilateral tender point sites and three
bilateral sham tender point sites were evaluated by the senior author.
The tender point scores were self-reported, on a 10-point scale, for
each point probed, with any scores obtained on the sham points
subtracted from the total.
All patients were given portable CES units and asked to treat
them-selves, via ear clip electrodes, one hour each day for the three
weeks of the study. The devices were preset to provide 0.5 Hz,
bilaterally symmetrical pulses with no direct current bias. The
current intensity could be adjusted from 0 to 500 microamperes, with
the majority of the patients choosing to
treat themselves at a level between 100 and 300 microamperes.
In addition to CES. the second two thirds of the patients were given
chiropractic treatment. The specific combination of therapy to be
utilized in the study would he aimed at restoring balance between the
muscles, the spine, and the nervous systems us a whole, with proper
posture thought of as being a key element in reducing the physical
forms of stress.
Each patient in the second group was asked to come to the clinic three
times a week, during the three weeks or the study, to receive hands-on
treatment. On their last visits, they were given the final treatment
followed 20 minutes later, by the final tender point evaluations, POMS
testing and final ratings on the self rating scales.
No attempt was made to adjust or change any medications the patients
may have been on.
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Procedure
Each study participant was analyzed for postural
imbalances when he/she came for the first treatment. Their primary
trigger points were established and correlated with their aberrant
biomechanics. The patient then received therapy, consisting of
specific chiropractic adjustments to the axial skeleton, with specific
trigger point therapy to affected musculature. Repetitive Postural
Reflex analysis was used to tine-tune the application of myofascial
therapies. Reflex muscle work was applied, while the trigger points
were worked on. Specific. stretches were performed after the manual
therapy session. This consisted of cervical Posture Pump therapy and
postural movement exercise. CES was performed during the same visit to
relax the patient, and facilitate the homeostasis between the body and
the brain.
Results
One of the CES patients (Group I) and three of the
CES plus chiropractic patients (Group II) did not complete the final
paper work, leaving two groups of 19 and 37 patients respectively.
Figure 1 shows how the two groups fared on percent improvement on the
items measured by the self-rating scales and. also. no their render
point pain scores. (See Fig- I below)
It is of interest that, while CES alone obtained an
average 26% gain in pain improvement- which compared favorably with
the maximum of 28% improvement found in medication studies as reported
above--Group II obtained a self-rated pain gain of 34%, and a tender
point improvement of 32%- -which is better than that found in
medication studies in fibromyalgia patients, Not shown in the table,
but perhaps of more significance in the current study, is that. while
63% of the
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A
Comparison of Cranial Electrotherapy Stimulation Alone or with
Chiropractic Therapies in the Treatment of Fibromyalgia.