device before and just following the CES treatment. A clinically
significant improvement in muscle spasticity was found in all patients
[15].
Another study had a serendipitous finding when re-searchers designed a
study to see whether or not "electrosleep" actually put patients to
sleep. Among 15 patients in this open clinical trial were two patients
suffering from Parkinson's disease and one diagnosed with dystonia
musculorum. Different types, intensities and amounts of CES current
were given over several weeks of experimentation, at the end of which
an unexpected finding was that the involuntary movements in the three
patients with muscle dysfunction were changed in character during the
passage of current, and eventually completely eliminated, as measured
by EMG [16].
In another study, researchers found that in at least some types of
patients, muscle tremor can be associated with the underlying level of
psychological stress. While researching muscle tremor in 53
withdrawing alcoholics, researchers found that patients who were under
the most psychological stress actually had fewer tremors than those
who were under only moderate stress. Following 40 minutes of CES,
those who formerly were under greater psychological stress began to
tremor more, presumably as their stress level was reduced, while those
who began under moderate levels of stress actually tremored less as
their stress level fell hack toward normal. Psychological stress was
measured by the Minnesota Multiphasic Personality Inventory and tremor
was measured with the Lafayette Instrument Steadiness Tester. It was
found that benzodiazepines, 25 mg. t.i.d. and 30 mg h.s., for three to
five days had no similar effect in altering the tremor of these
patients, such as was found with the 40 minute CES treatment [17].
In a study of 20 children with mild to severe spas-tic cerebral palsy,
aged 2.5 months to 15 years, CES or sham CES was given twice a day for
ten minutes each time for six weeks in a crossover design. The results
were evaluated on the Malden Gross Motor Rating Scales I, II, and III,
and the Advanced Gross Motor Skills Scale. There was significant
improvement in total gross motor performance in each group following
the active but not the sham treatment.
The authors concluded that treating children with spastic cerebral
palsy with CES in addition to physical therapy is superior to
conventional treatment alone [18].
In the latest such study to appear in the CES literature, 16 patients
diagnosed with minimal cerebral dysfunction, cerebral palsy and
spastic quadriplegia were given either occupational therapy (OT)
alone, CES
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alone, or OT and CES together for 12 weeks. CES was given twice daily
for 10 minutes over the 12-week period. Assessments were made using
the Southern California Sensory Integration Test and the Jebsen hand
function test.
Following treatment, improvement in the design copying scores of the
CES group averaged 59%, for the OT group, 35%, and for the OT/CES
group, 88%. Motor accuracy improved in the CES group 43% in the
dominant and 21% in the non-dominant hand. Improvement in the OT group
was 15% in the dominant and 45% in the non-dominant hand. In the
combined OT/CES group, improvement was 53% in the dominant hand and
68% in the non-dominant hand. In addition, the authors found that CES
patients whose scores were in the moderately impaired range during
pre-testing had improved to within normal limits in the 12 weeks of
CES treatment. They concluded that CES was a valuable adjunct to OT in
this patient population [19].
3. Research in chronic pain patients
While CES treatment became much more in evidence in pain management
programs in the 1990s, it was of-ten brought in as an adjunct to pain
management with the Alpha-Slim microcurrent stimulation device, which
also provided CES capability. In this regard, one review noted, "(CES)
is a primary modality effective for con-trolling anxiety, depression,
insomnia and generalized stress (which is) ubiquitous in pain
patients" [20].
3.1. Research in spinal pain
In 1999, a neurosurgeon used CES in an open clinical trial on spinal
pain patients who were waiting in line for the implantation of dorsal
column stimulators. In his study, CES was provided with Alpha-Stim SCS
units applied daily for one hour a day for three weeks. The results
were so impressive that he then conducted a double-blind,
placebo-controlled study [21]. In the 38 patients studied, the effects
of CES in reducing pain scores measured as "pain at best", "pain at
worst", and "pain in general", was dramatic and significant. No
positive placebo effect was found among the sham treated patients. The
results of both phases of his study are combined in Fig. 1.
The researcher currently plans to replicate the study with a greater
number of patients, since he feels that this is a seminal finding in
the treatment of chronic spinal pain patients. A replication of this
study is also just getting under way in Bombay, India [22].
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3.2. Research in Fibromyalgia
In 1999 a research protocol was developed for a multi-center study of
the use of CES in fibromyalgia patients. The protocol provided for
double-blind, placebo-controlled studies in larger medical centers and
for open clinical trials in smaller treatment centers. In the
double-blind protocol, the patients were to receive either CES
treatment helow sensation threshold at 100 microamperes of current
intensity, at 0.5 Hz, on a 5067( duty cycle, or sham treatment via
devices set exactly like the first, but using electrodes that would
not pass any current. The placebo control patients were to sit out the
three weeks without access to the CES device, to serve as controls for
any placebo effect in the sham-treated patients. The physician, other
therapists and the psychometrician were to remain blind to the
treatment conditions, as was the statistician who would evaluate the
study results. Patients were to be randomly as-signed to each of the
research groups. All subjects were to sign patient consent forms, and
each study would be run under the supervision and guidance of a local
Investigational Review Board to assure compliance with local community
standards in human subjects research.
Due to the strictness of the protocol, only one-third of the subjects
in each study would receive actual CES treatment for their
fibromyalgia. Accordingly, it was suggested that in those research
centers where CES treatment was shown to be effective, any of the
untreated, two-thirds of the patients who served as controls should be
offered three weeks of CES treatment one hour per day, in an open
clinical format, following the double-blind phase of the study. They
would often receive treatment at higher current intensity since there
would be no need to treat them below sensation level and they could
set the intensity to any level they chose. The treatment results of
those who agreed to a third testing following this treatment could he
included in the report as uncontrolled, clinical data.
The first double-blind study to be completed involved 60 patients in a
large private rheumatology practice in New Jersey [23]. The principle
investigator had served on the national panel that developed the
diagnostic protocol for fibromyalgia, and the protocol was approved by
the Investigational Review Board of the Robert Wood Johnson Medical
School.
Measures included the physician's evaluation of each patient's tender
points pre and post study, and the patient completed ten point self
rating of their overall level of pain, their quality of sleep, their
feeling of well being and their quality of life. They also completed
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The
Use of Cranial Electrotherapy Stimulation in the Management of Chronic
Pain: A Review