ces treatment of p disorders - atrium health · establish the usefulness of ces in pain management...

T h e j o u r n a l w i t h t h e p r a c t i t i o n e r i n m i n d .

VOLUME 8, ISSUE 3APRIL 2008

CES IN THE TREATMENT OFPAIN-RELATED DISORDERS

A PPM Communications, Inc. publicationwww.ppmjournal.com


T h e j o u r n a l w i t h t h e p r a c t i t i o n e r i n m i n d .

Commonsense Opioid-RiskManagement in Chronic Non-Cancer Pain

Personality Disorders and the Bipolar Spectrum

Maximizing Safety withMethadone and Other Opioids

Protecting Pain Physicians from LegalChallenges—Part 2

Commonsense Opioid-RiskManagement in Chronic Non-Cancer Pain

Personality Disorders and the Bipolar Spectrum

Maximizing Safety withMethadone and Other Opioids

Protecting Pain Physicians from LegalChallenges—Part 2

12 Practical PAIN MANAGEMENT, April 2008©2008 PPM Communications, Inc. Reprinted with permission.

Cranial electrotherapy stimulation(CES) is now being used andstudied as a treatment for

centrally-mediated pain syndromes thathave historically been refractory to inter-vention, such as fibromyalgia, multiplesclerosis, spinal cord injuries, and globalreflex sympathetic dystrophy. The safetyassured by the low level of current andpositive effects seen on the electroen-cephalogram also make CES a potentiallyefficacious treatment for headaches anddental pain. This review of the availabledata on CES suggests that sufficientresearch findings are now available toestablish the usefulness of CES in painmanagement as a stand-alone or add-ontreatment. This paper presents support-ing data for a sequence of different waysthat CES has been evaluated in pain man-agement. These include rigorous double-blind crossover studies, open clinical trials,physician surveys, patient self-reportsurveys, reductions in anesthetic require-ments, and dental applications for a varietyof challenging pain-related disorders.

BackgroundCranial electrotherapy stimulation (CES)involves the application of small amountsof current, usually less than one milli-ampere (1,000 microamperes), throughthe head via ear clip electrodes, for thepurpose of treating a variety of psycho-

logical and medical disorders. CES cameto the United States in the late 1960sunder the somewhat misleading name,electrosleep. It had been developed in theSoviet Union in the 1950s and quicklyspread throughout the former EasternBloc, then into Europe, Asia, and much ofthe West. It was already in use in Japanwhen it finally arrived in the US in the1960s. By the late 1960s, it was beingresearched in both animal and humansubjects at several U.S. medical schools,including the University of Texas at SanAntonio,1 the University of Wisconsin2 andthe University of Tennessee.3 Majorresearch reviews in 1985,4 1995,5 2002,6

and most recently in 2006-2007,7-17

summarized the progress of CES in Amer-ican medicine. The US Food and DrugAdministration now certifies CES devicesthat have met its standards to be sold byprescription for the treatment of anxiety,insomnia, and depression. CES has beenapproved for sale without a prescriptionin all of Europe, Canada, Mexico,Australia, Scandinavia, parts of Asia,South America, Latvia, Turkey, theMiddle East, and Africa.18

The treatment of pain is the mostrapidly evolving application of CES. Inaddition to a direct effect on various braincenters and relays, this modality may alsoraise the pain threshold due to the stress-reducing effects that occur when anxiety

and depression are reduced. While patientsexhibit significant responses to the usualresearch protocol of one hour treatmentdaily for three or four weeks, chronic painmanagement often requires CES to beused over longer periods of time fromdevices that are prescribed for home use.The progressive pathology underlyingmany chronic pain disorders limits CESto palliative relief. However, for long termpain management, CES has the addedbenefits of being anxiolytic, antidepres-sive, and helpful in insomnia, as well asbeing safe and cost-effective.

Dr. Ronald Melzack became interestedin central pain mechanisms from hisstudies of phantom limb pain in which,for example, a left leg amputee couldexperience intense pain seemingly in themissing left foot.19 Melzack theorized theimportance of a pain homunculus in thecortex that represents every part of thebody. Afferent fibers ascend from a givenbody area site to its corresponding site onthe homunculus. In this theory, neuromod-ules—residing in a larger neuromatrix thatencompass the homunculus—normallysend pain messages to the forebrain whensufficiently stimulated. The sources ofstimulation are afferent pain fibersascending to the neuromatrix by way ofthe spinothalamic tract.

When the afferent input from a specificbody site is terminated, the neuromodule

By Daniel L. Kirsch, PhD, DAAPM, FAIS and Marshall F. Gilula, MD


Cranial electrotherapy stimulation studies demonstratethat this modality is effective, safe, and easy to use asa stand-alone or complementary, cost effective, non-medication treatment for the management of pain—especially in chronic pain patients.

C E S i n t h e T r e a t m e n t o f P a i n R e l a t e d D i s o r d e r s

TABLE 1. Summary of the results of CES grouped according to 7 symptoms. The results were obtained from 47 physicians who reported on mul-tiple pain-related symptoms in 500 patients. Both the Table and its associated chart provide a comparison with the results of prior treatment.6

13Practical PAIN MANAGEMENT, April 2008©2008 PPM Communications, Inc. Reprinted with permission.



involved extends dendrites to otherneuromodules in an apparent attempt tomake up for the new lack of stimulation.Referred pain can result from such newcortical connections.20

It has long been known that stress candecrease the pain threshold.21 Thisapplies especially to stressful situations inwhich the person senses or experiences alack of personal control.22 Emotionaldisturbance such as anger or fear can bea real source of stress, as can unwantednoises or lack of sleep.

CES is a way to effectively alter painpathophysiology in the brain. Given themyriad of cortical processes that maycontribute to the experience of pain, itstands to reason that a form of electricalstimulation with proven efficacy in othercentrally mediated disorders such asanxiety,5,13,14 insomnia,8 and depression,11,12

would also make a valuable contributionto pain management. Early CES studies—

one on primates and one on a humanseizure subject—in which receptor elec-trodes were placed at different sites in thebrain, showed that CES current appliedacross the head sent electrical impulsesthroughout the brain, concentrating espe-cially along the limbic system.23,24 Morerecently, using LORETA brain imaging todetermine specific cortical effects of CES,Kennerly confirmed that the currentaffected the entire brain.25 Accordingly,CES stimulates the brain’s entire neuro-matrix directly, as well as the thalamus—an important site for pain modulation.

SurveysTable 1 summarizes the results of a surveyof 47 physicians reporting on a total of500 patients. This gives a fair overview ofthe effects of CES on seven symptoms,consistent with the prospective studies.6

This form of data is also useful to see therange of responses and average effect size

that one may reasonably expect fromtreatment. Note that the results across theseven symptoms evaluated are fairlyconsistent. For example, on the low end,0.00%-0.77% of patients became worseand 1.75%-11.85% had no change. On thehigh end 33.33%-51.86% had a markedimprovement, and 3.86%-10.60% had acomplete recovery.

To further validate the results of thephysician data, another survey collatedpatient self-reports of their own CES treat-ment. Table 2 summarizes a peer-reviewed analysis of 2,500 consecutivesurvey forms submitted by patients whowere prescribed an Alpha-Stim CESdevice.26 Most had multiple diagnoses.The only inclusion criterion was that thepatients had received at least three weeksof CES treatments. Pain was listed as theprimary diagnosis in 1,949, or 78% of thetotal group. Of those patients, 93%claimed significant pain reduction of

Peer-Reviewed Outcomes on CES Patients’ Self-Reports

Condition N Slight<24%

Fair25-49%

Moderate50-74%

Marked75-100%

Significant>25%

Pain (all cases) 1949136

6.98%623

31.97%74

138.02%449

23.04%1813

93.02%

Back Pain 40320

4.96%109

27.05%157

38.96%117

29.03%383

95.04%

Cervical Pain 26518

6.79%69

26.04%125

47.17%53

20.00%247

93.21%

Hip/Leg/Foot Pain 1606

3.75%43

26.88%53

33.13%58

36.25%154

96.25%

Shoulder/Arm/Hand Pain 15013

8.67%41

27.33%63

42.00%33

22.00%137

91.33%

Carpal Tunnel 250

0.00%5

20.00%17

68.00%3

12.00%25

100.00%

Arthritis Pain 18811

5.85%51

27.13%88

46.81%38

20.21%177

94.15%

TMJ Pain 15817

10.76%60

37.97%60

37.97%21

13.29%141

89.24%

Myofascial Pain 626

9.68%18

29.03%18

29.03%20

32.26%56

90.32%

Reflex Sympathetic Dystrophy 5510

18.18%16

29.09%19

34.55%10

18.18%45

81.82%

Fibromyalgia (alone) 14213

9.15%53

37.32%52

36.62%24

16.90%129

90.85%

Fibromyalgia (with other) 36333

9.09%131

36.09%152

41.87%47

12.95%330

90.91%

Migraine 1182

1.69%49

41.53%30

25.42%37

31.36%116

98.31%

Headaches (all other) 11220

17.86%30

26.79%24

21.43%38

33.93%92

82.14%

TABLE 2. Results of using CES at least three weeks from consecutive patient surveys.26



greater than 25%, ranging from a low of82% in chronic regional pain syndrome(reflex sympathetic dystrophy) to a highof 98% in those suffering from migraineheadaches, and 100% in carpal tunnelsyndrome. A majority (72%) of thepatients were female. The ages rangedfrom 15 to 92 years with a mean of 50years. The length of CES treatmentranged from the three-week minimumcutoff period to five years in two cases.The average period of use was 14.68weeks, or just over 3 1/2 months. Unlikethe physician survey, the patients were notasked what settings they used, how oftenthey used it, or for what length of time.The results reported by these patientswere similar to the physician survey of 500patients, with the patients self-reportsgiving slightly higher ratings overall.None of the patients reported any signif-icant adverse effects even though thesurvey specifically asked.

CES in the Treatment of Specific PainRelated Disorders

FibromyalgiaTwo well-conducted CES studies onfibromyalgia have been published.27,28

These studies used a similar researchprotocol measuring pain levels at tenderpoints according to the diagnostic criteriaestablished by the American College ofRheumatology,29 as well as self-ratingscales for overall pain, sleep, feeling ofwell being, and quality of life. They werealso given the Profile of Mood States(POMS) psychological test to assessanxiety, depression, fatigue, and cognitivefunction—as well as providing a TotalMood Disturbance score.

In double-blind CES protocols such asthose used in the fibromyalgia studies,CES current was limited to a subsensorylevel of 100 microamperes so the shamtreatment would appear identical in theuntreated subjects who received nocurrent at all. None of these studies foundany differences from the placebo effect inthe sham treated or control groups.Following the double-blind phase of thestudies, the control subjects were provideda device to treat themselves with CES athome and pre- and post-treatment scoresof the control subjects were also analyzed.

Lichtbroun Study. Lichtbroun foundthat CES yielded about a 28% reduction intender point pain scores (t=2.27,p<0.01).27 This is about the average reduc-

tion in pain scores found in multiplemedication studies.30 The self-rated overallpain level improved by more than 27%(t=3.04, p<0.002). Of the 60% of thepatients who went into the study complain-ing of very poor sleep, that numberdropped to 5% following the study(t=2.05, p<0.02). Fibromyalgia patientstreated with CES for three weeks also expe-rienced significant improvements in vigor(t=2.97, p<0.01, two-tailed), and fatigue(t=1.93, p<0.03, one-tailed, p<0.06 two-tailed; df=38) from psychological meas-urements. Significant improvements werealso found in feelings of well-being(t=1.67, p<0.05) and quality of life(t=1.92, p<0.03). There was no positiveplacebo effect among the sham-treatedpatients in the Lichtbroun study.

A second arm of this study allowedpatients who were in the sham group totreat themselves at home following thedouble-blind part of the study. The 23 ofthe 40 controls who agreed to be crossedover were allowed to increase the CEScurrent. This produced even greaterimprovements as measured by the tenderpoint scores (t=3.27, p<0.001), overallpain level (t=1.68, p<0.05), quality ofsleep (t=3.89, p<0.001), feelings of wellbeing (t=5.33, p<0.001), and quality oflife (t=5.23, p<0.001).

Cork Study. Cork conducted the otherdouble-blind crossover study that exam-ined the effect of CES on pain associatedwith fibromyalgia.28 He randomly allo-cated 39 subjects to a CES treatmentgroup and 35 subjects to a sham treatmentgroup. Pain Intensity, McGill Pain Score,tenderpoint score, Profile of Mood States,and Oswestry Score Measurements weretaken at baseline and after three weeks.Three weeks after crossover of the shamgroup to active CES treatment, all meas-urements were repeated. Cork’s studyshowed an improvement in pain intensityat the p<0.01 level compared to sham andp<0.001 in the sham group scores aftercrossover to active treatment. The McGillScore was not significant in the initialthree week trial but showed a p<0.001 insham group after crossover. Tenderpointscore initially showed a p<0.01 comparedto the sham group and a p<0.001 in thesham group after crossover. Profile ofMood States showed a difference ofp<0.01 compare to the sham group andp<0.001 in the sham group after cross-over. No significant effect was observed inthe Oswestry Score which is a disability

scale rather than a functional assessmentof pain. That prompted the authors toconclude that longer follow-up studieswould be necessary to observe changes inthe self-rated disability scale. The authorsalso concluded that CES appears to be aneffective, well-tolerated treatment forfibromyalgia and those involved in thetreatment of fibromyalgia should includeit in their clinical armamentarium giventhe demonstrated safety of this non-inva-sive modality.

The Licthbroun and Cork studies ofCES for fibromyalgia are rigorous double-blinded clinical trials. As an initialreviewer of Licthboun’s study stated,“This article is certainly intriguing. Theresults are so positive in such a difficult-to-treat population that one becomesskeptical. Nonetheless, positive results ina double-blind controlled study need tobe taken seriously.”31

It should certainly be taken seriouslynow that it has been replicated by Cork inan equally rigorous university-basedrandomly controlled trial. While longitu-dinal studies still need to be conducted,the best long term data to date is from theresults supplied by patients on theirsurveys that clearly demonstrate favorabledata representing as much as two years oftreatment with CES in some individuals.

As can be seen from the survey data inTable 2, 91% of patients reportingfibromyalgia and at least one comorbidsymptom rated their symptoms as havingimproved significantly by 25% or greater.Nine percent had experienced less than25% improvement, 36% rated theirimprovement as being between 25 to 49%,and the largest group of 41% rated theirimprovement as being between 50 and74%. There was also a group representing13% of the fibromyalgia patients whorated themselves as nearly symptom-free.This yields a mean effect size of r=.65,which means that the average fibromyal-gia patients improved 65%, a very higheffect size in this refractory condition.

Multiple SclerosisFrom the survey summarized in Table 2,12 of the responses had been sent in bypatients who had been prescribed a CESdevice for their multiple sclerosis (MS).They claimed an average improvement of46.57% (range of 0-99%) in their symp-toms. 10 of the 12 patients were female.Their ages ranged from 21-52 (averageage was 39), and they had used CES for



one to eight weeks, with an average of 4.4weeks, or one month. Based on thisencouraging preliminary evidence, asmall pilot study was conducted.32 Aftergiving informed consent, 5 patients (3females) underwent CES treatments forone hour a day for one month, at 0.5 Hzfrequency setting and at a comfortablelevel of current between 100 and 300 µA(microamperes). Ages ranged from 53-68years old (average age was 60). Time sinceMS diagnoses ranged from 10-38 years(average of 21). Improvement was notedin 7 of the 10 symptoms measured as seenin Figure 1. Self rated spasticity improved54%, vision improved 50%, sensory ability(ability to feel, as in the sense of touch)improved 45%, fatigue improved 40%,pain improved 29%, and hand functionimproved 22% in the left hand and 12%in the right hand. Bladder, cognitive, andmobility/gait function were not rated assignificantly improved by these patients.The author concluded that while this isonly a pilot study, the results were consis-tent with survey data and testimonialletters received so this pilot study is prob-ably a fairly accurate assessment of whata physician might expect when prescrib-ing a CES device for use by MS patients.

Spinal Cord InjuriesSpinal cord injuries (SCI) is another areathat is attracting CES researchers.Wharton presented the first paper on CESfor SCI at the annual meeting of theAmerican Spinal Injury Association inNew York in 1982.33 He had completed adouble-blind study of the use of CES withparaplegics and quadriplegics who werein an inpatient rehabilitation program inDallas, Texas. Patients were given eithersubsensation level CES or sham CES onehour daily for three weeks, Mondaythrough Friday. They were pre- and post-tested on standardized psychologicalmeasures of depression, anxiety, andcognitive function. It was found thatpatients receiving actual stimulation hadsignificant improvement in all areas meas-ured, while no placebo effect was foundfrom sham treatment. The presentersreported that CES was subsequentlyemployed routinely as a hospital treat-ment protocol. They reported that theirphysical therapists commented onpatients having much better moraleduring muscle exercise training when theyused a CES device during the mandatorypassive exercise sessions. The MS patients

completed their exercise sessions withlittle or no complaining, crying, or otheremotional acting out of negativity.

A double-blind crossover study of CESfor chronic pain in SCI patients wasconducted in the United Kingdom.34

Treatments were applied twice daily for 53minutes on four consecutive days. After awashout period of eight weeks, all subjectsreturned to treatment and were crossedover to the opposite condition (active tosham, and sham to active). Pain decreased51% in the treated group, but did notdecrease significantly in the sham treatedsubjects. After crossover, the originalsham subjects reported only 59% of thepain they reported at the commencementof treatment. No significant differenceswere determined in mood. However, anal-gesic and combined antidepressant andanxiolytic drug use in subjects receivingCES after crossover decreased to 46% and53%, respectively, of the average pre-study drug use. No similar decrease in theuse of the drugs was noted in the samesubjects after sham treatment in the firstarm of the study.

Pain levels were significantly lower(p=0.0016) in the CES-treated subjects ascompared to sham-treated subjects (p=0.50). After crossover, sham subjects alsoshowed significant improvement due toreceiving the active treatment (p<0.005).Subjects receiving CES reported usingsignificantly (p<0.05) less analgesicmedication (46% of the average pretreat-ment level) and significantly (p<0.05) less

(53%) of the average pre-treatment levelof combined antidepressant and anxi-olytic medications. No significant differ-ences were found between groups inplasma assays. However, there weremarked differences (p<0.05) betweengroups in salivary cortisol concentrationsin the first arm and salivary cortisol wasalso lowered significantly (p<0.05) in thesham group after crossover to active CEStreatment. Decreases in cortisol levelssuggest improvements or lessening sever-ity in the ability to handle stress.

The authors added that no adversereactions were reported and that subjectsreported a feeling of relaxation that coin-cided with lower blood pressure.

Another double-blind, sham controlledstudy with random assignment examinedthe effects of daily one-hour active(N=18) or sham (N=20) CES treatmentsfor 21 consecutive days on pain intensityand interference activities.35 Subjectsconsisted of 38 male veterans—sixmonths to 60 years post SCI—receivingcare at a Department of Veterans AffairsSCI Center. Treatments were self-admin-istered at home. The active CES groupreported significantly decreased dailypain intensity (p=0.03) compared withthe sham CES group. The active CESgroup also showed significantly decreasedpain interference (p=0.004).

The active and sham CES groups didnot differ significantly with regard to theiraverage pre-session pain ratings. Therewas a mean pain rating score of 6.46 for

FIGURE 1. Improvements in 5 patients diagnosed with multiple sclerosis after one month ofdaily CES treatments.32



the active CES group versus 6.08 for thesham CES group. The average change indaily pain intensity from pre- to post-session was significantly larger (p=0.03)for the active CES group (mean=-0.73)than the sham CES group (mean=-0.08).The treatment effect size was medium tolarge (Cohen d=0.76). Participants whoreceived sham CES did not show signifi-cantly reduced pain (p=0.34), whereasparticipants who received active CES didshow significantly reduced pain (p=0.02).After the double-blind phase, the shamgroup were offered the opportunity tocross over to an open label phase with anactive CES device for another 21 consec-utive days. The 17 sham CES participantswho subsequently participated in the openlabel phase reported significant post-session pain reduction (p=0.003). None ofthe changes in the BPI pain intensitysubscale items were statistically significantfor any of the three groups. However, inpaired t-tests for the active CES group, 7of the 10 individual pain interferencesubscale items significantly changed and

reflected small to moderate effect sizes.This included: general activity (Cohend=0.67), self-care (Cohen d=0.58), sleep(Cohen d=0.53), social activities (Cohend=0.51), normal work (Cohen d=0.45),enjoyment of life (Cohen d=0.42), andrecreational activities (Cohen d=0.38). Apaired t-test within the active CES groupshowed that the composite pain interfer-ence score for both groups decreased sig-nificantly (mean change=14.6, P=0.004,Cohen d=0.50). Neither the individualBPI pain interference subscale items northe composite pain interference scorechanged significantly in the sham group(mean change=-4.7, P=0.24). Aftercrossover into the open label phase, paininterference with sleep decreased signifi-cantly (Cohen d=0.40). Changes weregreater in the three participants in theactive group who had non-traumatic SCI.

The authors concluded that CES caneffectively treat chronic pain in personswith SCI and may lower the burden oflong-term pharmacologic management.

As a result they are now conducting a largethree-year multi-site study of CES for SCIin veterans.

CES is offered routinely in the paintreatment program at the Michael E.DeBakey Veterans Affairs Medical Centerin Houston, Texas, where the above citedSCI study was conduced. A case wasrecently published from there of a 60-year-old Afro-American male with wors-ening pain from a back injury coupledwith PTSD that developed while serving inVietnam.15 The initial treatment goalswere to reduce pain, stabilize and improvesleep, and help him regain a sense ofcontrol over his daily activities. The 10-session treatment plan consisted of CESto reduce anxiety and improve sleep andwas coupled with self-monitoring skillsalong with hypnosis to help modulate hispain and to begin the resolution of histrauma. By the seventh session, thepatient was “very pleased” with treatment,his pain was mostly gone, sleep improved,and no pain medication had been takenduring the previous week. At the final

session he was able to get “very relaxed”using CES and hypnosis, had not beentaking any pain medication, his sleep wasquite regular and satisfactory and his painhad been under control and “milder.” Inaddition to the patient’s self-reportedimprovement in his pain and relatedsymptoms, the BPI and the Center forEpidemiological Scale-Depression (CPS-D) indicated a number of improvementsincluding significant reductions in painintensity, pain interference, and depres-sive symptoms. The patient reportedmeaningful reductions of pain interfer-ence in all aspects of his daily function-ing. Perhaps equally significant was asubstantial reduction in pain medicationuse and the ability to function withminimal assistance from healthcareproviders.

The authors concluded that when effec-tive, CES and hypnosis can help patientshave greater confidence in treatmentsoffered by psychologists for pain manage-ment and may help make them more open

to participating in other psychologicalinterventions that have demonstratedefficacy for pain management such ascognitive-behavioral therapy (CBT).Because of their brevity, treatments suchas CES, hypnosis, and CBT can also beoffered as the sole approach to patientswho may not have the resources or timeto participate in more time-intensivetreatment.

Reflex Sympathetic DystrophyA case report was published on a patientreferred to as ‘WHH,’ a 60 year old malewith an intracranial traumatic brain injury(TBI) and global (full body) reflex sympa-thetic dystrophy (RSD).36 In spite of severedisabilities of his brain and body, WHHcontinued to serve his country in his posi-tion on the Executive Staff of the Presi-dent’s Committee on Employment ofPeople with Disabilities. Daily 20-minuteCES treatments provided satisfactory painrelief for WHH to complete his tasks andenjoy a relatively higher quality of lifethan he was able to have with drugs alone.

Prior to CES, WHH has been prescribednumerous medications including Prozac20mg q.i.d., Catapres Tab 20mg q.d.,Effexor 100mg in AM and 50mg atbedtime, Levo-Dromoran 1mg b.i.d.,Balofen 10mg split AM and PM, Risperdal7.5mg at bedtime, Kolopin 0.5mg one tab3 to 4 times per day as needed, C-Dextromthrph 60mg t.i.d., and Fentanylpatches over four years. This regime didlittle to reduce his whole body chronicintense critical pain and burning. Nor didit relieve his difficulty sleeping. Standardmilliampere transcutaneous electricalnerve stimulation (TENS) did not help.WHH claimed these treatments made himworse and was concerned about the short-and long-term side effects the drugs hadon his ability to function.

Following CES treatment, WHH exhib-ited marked relaxation, with a reducedanxiety level and a significantly enhancedpain threshold. Based on these positiveresults, he was prescribed daily 20 minuteCES treatments via ear clip electrodes.WHH credits the CES treatment forallowing him to return to work and forimproving his family and social life. Priorto CES, he claimed that “life was notworth living to the degree that suicide wasan attractive option.” He found this treat-ment provided him a moderate improve-ment of 50-74% relief from his pain,anxiety, depression, headaches, and

“The authors concluded that CES can effectively treat chronic pain

in persons with SCI and may lower the burden of long-term pharma-

cologic management. As a result they are now conducting a large

three-year multi-site study of CES for SCI in veterans.”



muscle tension, and a marked improve-ment of 75-99% in his insomnia, as shownin Figure 2.

The effects of a single CES treatmentlasted for six to eight hours, allowing himto get through the day, then the pain grad-ually returned prior to the next CES treat-ment, but never to his pre-CES painlevels. In his own words, “The Alpha-Stim100 has given me short term relief frommy pain levels that medications have notbeen able to accomplish. While the reliefperiods may only be for eight hours or so,these near pain-free hours allow my bodyto recycle itself, granting me an improvedquality of life. Without the Alpha-Stim100, the constant ‘level 10’ debilitatingpain levels leave me with no physical oremotional reserves to carry on daily life.The Alpha-Stim 100 has no side effects,whereas my medicines have profound,crippling, and lasting side effects thathave impaired my bowel and colon. Theseimpairments can not be reversed.” On azero (no pain) to 10 (maximum pain)scale, WHH says CES reduces his painlevel from a 10 to a 3 which he describesas “the difference between standing on abusy street in New York at 5 PM and flyfishing on a tranquil creek.” He added“CES provides me with a measure of painrelief that brings me back from the depthof despair and gives me a wedge of hope.”

CES reduced his pain level to a levelwhere he was able to perform his dailyexercise routine. He was also able to restbetter at night which he credits as creat-ing a “positive emotional and physicalself-environment.” He reported feelingmore rested in the morning. He was ableto increase his work hours to 30 to 40hours per week, up from a maximum of15 hours prior to CES.

Following CES, his medication has beenreduced to Prozac 10mg q.d., CatapresTab 0.1mg b.i.d., Effexor 50mg AM and25mg PM, Levo-Dromoran 1mg b.i.d.,Restoril 7.5mg at bedtime, Kolopin p.r.n.,and Neurontin 400mg p.r.n.

HeadachesCES reduces stress and anxiety, acommonly accepted cause for manyheadaches, and treats the entire head andbrain. Perhaps the earliest U.S. study onheadache was done as a Masters Degreethesis at the University of North Texas inDenton.37 In that double-blind, placebo-controlled study, 18 migraine headachepatients were divided into three groups ofsix each: a treatment group, a sham treat-ment group, and a placebo control group.In the treated group, CES was given for45 minutes a day for 15 days, Mondaythrough Friday. Over a two week periodimmediately following the study it was

found that CES-treated patients—but notthe sham-treated or placebo controlpatients—reported significant reductionsin both headache intensity and duration.

In another study of migraineheadaches—this time a doctoral disserta-tion research project—36 patients wereassigned to biofeedback (BF) consisting ofelectromyogram, thermal biofeedback,and Quieting Reflex training, CES, or BFcombined with CES.38 Treatments wereadministered twice a week for 15 minuteseach over a one month period. Thepatients maintained a daily record of thefrequency and intensity of headaches,then followed up on the record over a onemonth, two month, and three monthperiod following the initial treatments.

There was no difference between groupsreceiving either treatment at the end of theeight treatment sessions, but a steadilyincreasing cumulative improvement tookplace over the three month follow-upperiod following the study as shown inFigure 3. The BF group had an accumu-lative improvement of 400% while thecombined BF/CES group had an accumu-lative improvement of 1,100% (11 timesbetter) by the end of the third month.

Solomon studied 112 patients withtension headaches.39 Inclusion criterionwas a minimum of four headaches a weekfor a year, and these had to be severeenough to require treatment withprescription medications. Prior to and atthe end of the study, patients rated theintensity of their headaches on a 10-pointself-rating scale. The patients were askedto use CES for 20 minutes each time theyhad a headache and, if the pain did notgo away, to use it for a second 20 minutes.The average CES treated patients’headache intensity dropped from 6.1 to4.0 on the 10-point scale, or approxi-mately 35% at the conclusion of the 10-week study, while the sham-treatedpatients reported an 18% improvement.

Romano studied the ability of CES toreduce headaches in 100 fibromyalgiapatients who were asked to use CES for 4treatment periods of 20 minute each dayfor up to 2 months. In this open clinicalstudy the patients rated their improve-ment at 50% or greater in terms of reducedheadache frequency and intensity.40

As shown in Table 1, 47 physiciansresponding to a survey treated a total of151 headache patients with CES. Theyrated the treatment gain in 90% of thepatients to be 25% improvement or better,

FIGURE 2. Remarkable improvements ranging from 52% to 83% in 7 areas of the major com-plaints in a global RSD patient.36



with 74% reporting at least a 50%improvement.

Patient surveys shown in Table 2 indi-cate that 118 patients who suffered frommigraine headaches improved an averageof 61%, while 112 who suffered fromtension headaches improved 56%. Thatimprovement is somewhat lower than inthe migraine group, possibly due to lackof consistency in diagnostic labels or inthe individual differences of neuromuscu-lar involvement of neck or shouldermuscles that did not resolve sufficientlyfrom CES.

Dental PainIn a double-blind dental study, 50 patientswere divided into two groups: 30 whoreceived CES treatment and a secondgroup of 20 receiving sham CES treat-ment.41 They were randomly assigned toprocedures including oral surgery,restoration, tooth extractions, rootplaning, pulp extirpation, and temporo-mandibular joint therapy.

It was found that 24 of the 30 CESpatients (80%) were able to undergodental procedures without other anesthe-sia, while 15 of the 20 sham-treatedpatients (75%) requested anesthesia. Inthe operative groups, 13 of 14 CESpatients (93%) did not require anesthesia,while four of seven sham-treated patients(43%) did. All patients required anesthe-sia for endodontic procedures. All CESpatients stated that the use of CES wouldbe their first choice in future dental visits.

Another dentist used CES in 600 dentalprocedures over a 12-month period. 76%of the patients reported a 90% or greaterreduction in pain with CES and did notrequest additional anesthetics.42 When theresults were broken down by procedure,83% of the patients who underwent 71scaling and prophylactic procedures didnot ask for additional anesthesia, com-pared with 76% of those undergoing 473restorative procedures, and 55% of thoseundergoing 29 crown preparations. Oneadditional clinically significant findingwas that all patients reported feeling morerelaxed than usual while in the dentalchair.

Studies of Anesthetic EquivalencyThere have been two studies that assessedthe equivalency of CES to various types ofanesthetics. In a rather straightforwardstudy in which he compared CES withvarious concentrations of N2O, Stanley

gave a group of 90 urological patients and30 abdominal surgery patients either75%, 62.5% or 50% N2O alone or hecombined a similar concentration of N2Owith CES.43 After 20 minutes of treatment,patients were given a painful stimulus witha Kocher clamp clamped at the secondratchet and applied to their upper, innerthigh for one minute. Measurements ofpain included patient movement, systolicblood pressure, heart rate, respiratoryrate, and minute ventilation. It was foundthat CES increased the potency of N2Oby approximately 37% at each level, beingbetween 0.3 and 0.4 MAC in analgesicpotency when combined with N2O. Theauthors also found that the CES groupexperienced more prolonged analgesiaafter recovery of consciousness.

In a somewhat more elaborate study,CES equivalency to the narcotic fentanylwas studied with patients undergoingsurgery. Fifty patients who were toundergo urologic operations were dividedinto two groups to receive either CES orsham CES in addition to normal anes-thetic procedures.44 All patients had anes-thesia induced with droperidol (0.20mg/kg IV), diazepam (0.2mg/kg IV), andpancuronium (0.8mg/kg IV). Anesthesiawas maintained during the surgical proce-dure with fentanyl given in 100 micro-gram IV increments every three minutesas necessary to maintain the patient at the

required level of anesthesia. It was foundthat an average of 33% less fentanyl wasrequired in patients who simultaneouslyreceived CES treatment.

More recently, an anesthesiologist atthe Rene Descartes University of Paris,France took advantage of a personal expe-rience to determine whether CESimproved the level of postoperative anal-gesia by potentiating anesthetic agentsused during the intra- and postoperativephases.45 Included were analgesicsinjected through an epidural thoraciccatheter (T8-T9) positioned at the end ofan esophagectomy. Another reason for aself-experimentation was to be able toevaluate the “psycholeptic” effects of CESto gain a better understanding of theproblems associated with pain treatment.CES was initiated two hours before anes-thetic induction without any tranquilizeror other medication. It was then continu-ously applied during the entire surgicalprocedure and an additional 48 hourspostoperatively in the intensive care unit.The usual anesthetic protocol was usedduring surgery. During the initial 48 post-operative hours with continuous applica-tion of CES, a decrease of the epiduralanesthetic dose requirement was observedfor ropivacaine and sufentanil (-25% and-60%, respectively). A similar decrease inthese medications was also measured onday two, when CES was terminated. This

FIGURE 3. Improvements in pain intensity and frequency ratings in migraine patients over athree month period following eight treatments of biofeedback and the addition of CES to thesame biofeedback program.38



decrease continued and was amplified onday three for both ropivacaine and sufen-tanil (-50% and -73%, respectively). Onday four, the need for epidural anesthet-ics were totally suppressed (one day beforethe normal conventional weaning sched-ule planned for by the ICU physician withthis type of surgery). The authorsconcluded that future clinical trials needto be conducted to show the significantadvantages of CES in alternative andcomplementary medicine.

CES in Physical and Occupational TherapyIn a 1963 U.S. CES study, 23 patients whohad been diagnosed with hemiplegia,paraplegia, and muscle spasm followingtraumatic injuries were given CES treat-

ments of one hour each day for four daysin an open clinical trial.46 Muscle spastic-ity was tested with an electromyogram(EMG) before and just following CEStreatments. A clinically significant im-provement in muscle spasticity was foundin all patients.

In a study of 20 children, ages 2.5months to 15 years, with mild to severespastic cerebral palsy, CES or sham CESwas given twice a day for 10 minutes eachtime for six weeks in a crossover design.The results were evaluated on the MaldenGross Motor Rating Scales I, II, and III,and the Advanced Gross Motor SkillsScale. There was significant improvementin total gross motor performance in eachgroup following the active but not thesham treatment.47 The authors concludedthat treating children who had spasticcerebral palsy with CES, combined withphysical therapy, is superior to conven-tional physical therapy alone.

Occupational therapy (OT) alone, CESalone, or OT and CES together wereprovided to 16 patients diagnosed withminimal cerebral dysfunction, cerebralpalsy, and spastic quadriplegia.48 CESwas given twice daily for 10 minutes overa 12 week period. Assessments weremade using the Southern CaliforniaSensory Integration Test and the Jebsenhand function test. Following treatment,

improvement in the design copyingscores of the CES group averaged 59%compared to 35% for the OT group, and88% for the combined treatment group.Motor accuracy improved in the CESgroup 43% in the dominant hand and21% in the non-dominant hand.Improvement in the OT group was 15%in the dominant hand and 45% in thenon-dominant hand. In the combinedOT/CES group, improvement was 53% inthe dominant hand and 68% in the non-dominant hand. In addition, the authorsfound that CES patients whose scoreswere in the moderately-impaired rangeduring pre-testing had improved towithin normal limits over the 12 weeksof CES treatment. They concluded that

CES was a valuable adjunct to OT in thispatient population.

Other Pain StudiesNeurosurgeons in a Korean hospitalconducted a study of 20 refractory chronicpain inpatients.49 Daily CES treatments ofone hour per day, five days a week, weregiven for three weeks. Ages ranged from18 to 75 years old (mean=44 years) and15 (75%) were female. Both CES andmicrocurrent electrical therapy (MET)probe treatments were given with thesame device (Alpha-Stim 100) using thesame waveform applied to the brain andbody. Although three patients out of 20obtained no relief from this treatment, sixobtained complete relief, and eightreceived significant relief ranging insubjective estimation from 33% to 94%.The authors concluded that the combina-tion of CES and MET can be an effectivetreatment for long-standing chronic pain,as well as for pain of shorter duration.

DiscussionThe above studies represent an entirespectrum of study design ranging fromcase reports to survey data to open clini-cal trials and rigorous double-blind,placebo-controlled research. Yet in everyreport, treatment with cranial electrother-apy stimulation has been accompanied by

some dramatic reduction in the percep-tion of pain in every pain category studieddespite the fact that most of the studiesdescribed are time-limited and have arelatively small number of subjects. Onenecessary caveat is that there is a hugedisparity between current theories of painand the actual knowledge of how neuro-electric devices actually work. In ourcurrent stage of knowledge, putativemechanisms of pain are quite fragmentedand it becomes even more so whenattempting to explain why certain modal-ities work as well as they do. The authorsare working on a book that will detail thecurrent state of knowledge of CES, includ-ing mechanisms.

It is not clear why putting microcurrentelectrical stimulation across the headwould reduce pain in the body. Whilesome would point to a possible increasein endorphins, two studies that looked forthis did not find it, although one foundan increase in serotonin and a decrease incholinesterase.50 Another study found anincrease of MAO-B in blood platelets andan increased concentration of GABA inthe blood following CES treatments, butdid not find an increase in serotonin,dopamine, or beta-endorphins in theblood.51

Animal studies suggest that CES isapparently effective in bringing neuro-transmitters back into homeostaticbalance when that balance is deliberatelydisrupted.3 It could be possible that whenthe brain’s normal homeostasis has beenshifted into a stress pattern over a periodof time—an occurrence suggested bySelye’s theories to be somewhat frequentin our day and age52—CES may be effec-tively nudging the nervous system backtowards a balance point that more resem-bles homeostasis. This may be accompa-nied by a reduction in stress-relatedhormones such as cortisol that are knownto play a role in increased pain perception.

There is also increasing evidence for acentral pain neuromatrix in the cortexwhich is responsible for processing painmessages throughout the body—accord-ing to the writings of Melzak and others.Pain messages can occur even in theabsence of perceptible pathology, or inthe absence of the body parts them-selves—as in the examples of phantomlimb pain or pain patterns persisting afterthe removal of organs. The neuromatrixis thought to change under certain condi-tions such as physical trauma of various

“...CES may be effectively nudging the nervous system back

towards a balance point that more resembles homeostasis. This may

be accompanied by a reduction in stress-related hormones such as

cortisol that are known to play a role in increased pain perception.”



kinds that interrupt normal incomingstimulation. Notable researchers such asRonald Melzack are now theorizing thatthe pain neuromatrix may be moreimportant in producing chronic painstates than previously considered.19

Accordingly, one can speculate that sinceCES stimulates every area of the brain thistype of stimulation would include effectsin the area in which the pain neuromatrixis thought to reside.24,25,53

From a different perspective, researchersat the St. Vincent Medical Center inConnecticut have found what appears tobe occult damage in the lower medullarysensory and motor pathways in complexregional pain syndromes (reflex sympa-thetic dystrophy and causalgia) andfibromyalgia. They state, “We suggest thatbilateral spinothalamic and corticospinaldeficits, with a conspicuous ipsilateralhemisensory and hemiparetic pattern,contralateral cranial nerve XI dysfunc-tion, and lack of other consistent cranial

nerve findings are compatible withdysfunction of lower medullary sensoryand motor pathways.” Prior trauma wasreported by 51% of their 145 patients.This group of individuals had a high inci-dence of whiplash injury, falls, and phys-ical assaults.54 It could be that CES stimu-lation of the medulla (using ear clip elec-trodes bilaterally) provides a bilaterallysymmetrical stimulus into the area overtime, varying only by the treatmentparameters chosen.

Heffernan found that certain types ofCES stimulation reduced the Fast FourierTransform root mean square (RMS) of theEEG significantly, leveling out the peaksnormally found in pain patients. Thepatients rated their pain as significantlyreduced—coincident to the spectralsmoothing of the EEG.55 He also theo-rized that a significantly concentratedchaos correlation dimension in the EEGfollowing CES suggested a heightenedorganization of a formerly less organizedEEG in pain patients. This was accompa-nied by a reduction in pain and stresssymptoms.56

The use of CES with pain patients isincreasingly being supported by theoutcome of a small number of well-designed research protocols as well as alarge amount of pilots, careful meta-analyses, and a burgeoning amount ofethical and accurate testimonials. Its well-described efficacy in controlling some ofthe anxiety, depression, and insomniaubiquitous in pain patients is a significantadded benefit.

In contrast to pain medications thatmay carry substantial risk, side effectsfrom CES are rare, primarily minor self-limiting problems, such as acceptability toindividual patients, headaches (one in506) and electrode burns (one in 910).6 Asa stand-alone or complementary, costeffective, non-medication treatment forthe management of pain—especially inchronic pain patients—CES usage isexpected to increase as practitionersbecome more aware of its efficacy, safety,and ease of use. CES also carries with it

the clear potential for helping to increasethe safety margin of nearly any medica-tion whose dosage can be efficaciouslydecreased when incorporating this safeand effective neuroelectric modality intothe treatment plan. n

Daniel L. Kirsch, PhD, DAAPM, FAIS is aninternationally-renowned authority on elec-tromedicine and the recipient of the 2008Richard S. Weiner Pain Education Award. Heis a board-certified Diplomate of the AmericanAcademy of Pain Management, Fellow of theAmerican Institute of Stress, Member of theInternational Society of Neurofeedback andResearch, and a Member of Inter-Pain (anassociation of pain management specialists inGermany and Switzerland). He served as Clin-ical Director of The Center for Pain and Stress-Related Disorders at Columbia-PresbyterianMedical Center, New York City, and of TheSports Medicine Group, Santa Monica, Cali-fornia. Dr. Kirsch is the author of two books onCES titled, The Science Behind Cranial Elec-trotherapy Stimulation, 2nd Ed. published byMedical Scope Publishing Corporation,Edmonton, Alberta, Canada in 2002; and

Schmerzen lindern ohne Chemie CES, dieRevolution in der Schmerztherapie, Interna-tionale Ärztegesellschaft für Energiemedizin,Austria 2000 (in German). Dr. Kirsch is aresearch consultant to the US Army and VAMedical Centers and currently spends much ofhis time giving lectures at national militaryconferences and grand rounds at VeteransAffairs Medical Centers and U.S. Army hospi-tals such as Brooke Army Medical Center,Walter Reed Army Medical Center andWilliam Beaumont Army Medical Center. Bestknown for designing the Alpha-Stim line ofmedical devices, Dr. Kirsch is Chairman ofElectromedical Products International, Inc. ofMineral Wells, Texas, USA with additionaloffices in Europe and Asia. Dr. Kirsch can bereached at [email protected].

Marshall F. Gilula, M.D. is a Diplomate ofthe American Board of Psychiatry and Neurol-ogy and a Diplomate of the American Board ofMedical Electroencephalography. He is also aboard-certified Instructor in Biofeedback andNeurotherapy. In 1978 he was a US-USSRNIMH Exchange Scientist working withcranial electrotherapy stimulation and generalpsychophysiology techniques at the P.K. AnokhinInstitute, Soviet Academy of Medical Sciences,Moscow. In 1983, Dr. Gilula was the firstMotoyama-Ben Tov Fellow at the Institute ofLife Physics, Tokyo (Mitaka-shi), Japan andresearched neuroelectric methodology and theEEG of altered states with Professor HiroshiMotoyama. Dr. Gilula has had four years ofresidency and postdoctoral fellowship trainingin psychiatry and over seven years of postdoc-toral training in neurology (neurophysiologyand epilepsy). He has 40 years of experience inclinical psychiatry and was in the Departmentof Neurology at the University of Miami MillerSchool of Medicine from 1999 through 2003.Dr. Gilula was a Senior Fellow, Miami Centerfor Patient Safety, Department of Anesthesiol-ogy, University of Miami from 2003 through2005. Dr. Gilula is President and CEO of theLife Energies Research Institute in Miami. Hecan be reached at [email protected].

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efficaciously decreased when incorporating this safe and effective

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