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Cumulative Response from Cranial Electrotherapy Stimulation (CES) for Chronic Pain

Results from five CES sessions—administered over the course of treatment to 525 consecutive chronic pain patients—confirmed that an initial decrease in pain after the first session was typically followed by further decreases in pain from the cumulative effects of this modality.
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This is a welcome addition to the literature on electromedicine because it looks not only at the immediate effect but on the cumulative effect as well. No intervention controls chronic pain in one treatment so it is good to see Dr. Holubec prove that cranial electrotherapy stimulation persists and adds up to more pain relief over a series of treatments. While this may be obvious to practitioners, this study proves the observation that a series of electrical treatments directed to the brain are necessary to, and indeed can achieve, a clinically significant effect in pain management.

Cranial electrotherapy stimulation (CES) is an FDA-approved technology by physician prescription for the treatment of anxiety, depression and insomnia. While the use of electric currents in medical practice dates back more than 2,000 years, today’s interest in CES, originally called electrosleep, originated in France in 1902 by Leduc and Rouxeau. Leduc’s student, Robinovitch, made the first claim for inducing sleep from electrical treatment in 1914.1

Subsequent research interest revolved around electronarcosis and then electroconvulsive shock treatments through the late 1930s.2 Interest in the smaller amounts of electric currents involved in CES did not begin in earnest until 1958 when Gilyarovski published a book titled, Electrosleep.3

When American researchers started to study CES about 40 years ago, they soon found that while it did not necessarily induce sleep, it achieved significant clinical effects for mood disorders.4,5 Accordingly, the FDA changed the generic terminology from electrosleep to CES in 1978. A recently revised annotated bibliography of CES research summarized 126 human studies, 29 animal studies, and 31 review articles in the English language literature.6

The pain threshold has been found to be lowered when accompanied by the stress-related disorders for which CES has historically been prescribed.7 CES has previously been studied in conjunction with other aspects of microcurrent electrical therapy (MET) applied to the body via handheld probes or self-adhesive electrodes in a pain management practice.8 Results of that study of 20 patients revealed that those who continued at least two weeks of daily treatments exhibited an average of 73% improvement in their self-rated visual analogue pain scales and correlates well with this present study. CES has also been proven successful in double blind research for treating specific types of pain, such as fibromyalgia, reflex sympathetic dystrophy (RSD), and spinal pain.9-12 This present study is the first evaluation of the cumulative effects from multiple sessions of CES in the treatment of the wide range of pain diagnoses found in a typical pain clinic.

The Regional Pain Care Center of North Texas is a specialty clinic that receives referrals of patients with unresolved pain from other physicians. Because the effects of CES on these patients were unknown, it was determined to conduct an open clinical evaluation of the response of these refractory patients to 20 minutes of CES when the patients first entered the facility.

Materials and Methods

The devices used for CES in this study were the Alpha-Stim SCS (Electromedical Products International, Inc, Mineral Wells, Texas, It produces a bipolar modified square waveform of 0.5 Hz at a maximum current of 500 microamperes. Clip electrodes are placed on each ear lobe. Patients were allowed to set the current to a comfortable level. Most choose between 200 and 300 microamperes.

During the study, each patient was offered CES treatment upon entering the facility. Fewer than 1% refused the treatment. The remaining participants were asked to complete a pain questionnaire in which they described their area of pain and rated its intensity on a scale of 1 to 10—with 10 being the most severe pain they have experienced. Following the treatment, the patients received further evaluation and treatment prior to discharge. Patients who received other forms of electrotherapy in addition to CES were excluded.

A total of 525 patients were treated, 261 returned for a second treatment, 160 returned for a third, 57 returned for a fourth, and 26 returned for a fifth treatment. Patients were not specifically selected for additional CES treatments following the first but were offered the additional treatment if they were required to return to the clinic for other types of follow up. In general, the most severe cases were most likely to return. Treatments were spaced one day apart, except for patients who came on Thursday as the clinic is closed on Friday through the weekend. Those patients received treatment on the following Monday. Of the 525 initial patients treated, 343 (65.33%) were female, ages ranged from 9 to 91 years with a mean of 44.49 +/– 12.25.

Table 1. Response of pain patients to one to five 20-minute treatments with CES
Treatment Number Patients Not Responding Patients Responding Percent Improvement Patients Pain Free
First, N = 525
Initial Pain Level
42.40% 5.14%
Second, N = 261
Initial Pain Level
49.80% 10.73%
Third, N = 160
Initial Pain Level
53.99% 12.5%
Fourth, N = 57
Initial Pain Level
64.25% 10.52%
Fifth, N = 26
Initial Pain Level
70.64% 15.38%

Table 1 shows the results from the CES treatments. It can be seen that there is a percentage of patients who did not respond to CES treatment—as is the case in any treatment modality. The large group of patients (79.81%) who did respond to the initial CES treatment exhibited an impressive improvement of 42.40% from only one 20-minute dose. In subsequent visits, the number of patients grew smaller. However, the improvement was greater even though there was a higher initial pain level in these groups. The cumulative effect of CES was demonstrated by the increasing percent of patients becoming pain-free on consecutive visits.

The cumulative treatment effect can be seen in Figure 1. As the number of sessions progressed, there was a rising percentage of those not responding by the fourth and fifth treatments. This was due to the fact that the patients suffering with the most severe pain continued for additional treatment sessions. Even so, the percent improvement among the most severe group was still rising, as was the percent of patients achieving pain free status subsequent to the increasing number of treatments.

Figure 1. Patients who report being pain free after one to five 20-minute CES treatment sessions.

Table 2 shows the types of pain responding and not responding to CES treatment. There was no specific type of pain that would or would not respond to CES treatment. The distribution of pain areas were similar in the two groups except in patients diagnosed with RSD and fibromyalgia. It is known that CES is an effective treatment for RSD and fibromyalgia when longer treatment periods are utilized, but five treatments are not enough to establish control of these pathologies.10,11

Last updated on: October 11, 2012
First published on: November 1, 2009