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Chronic Pain Cranial Electrotherapy StimulationThe Use of Cranial Electrotherapy Stimulation in the Management of Chronic Pain: A Review

Daniel L. Kirsch  and Ray B. Smith

NeuroRehabilitation, 14(2):85-94, 2000

Fig. 1. The effect of microcurrent treatment on chronic spinal pain.

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
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].

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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NeuroRehabilitation 14(2):85-94 2000

Used with permission of Electromedical Products International, Inc.

©2006 by

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The Use of Cranial Electrotherapy Stimulation in the Management of Chronic Pain