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Safety and Effectiveness of Cranial Electrotherapy

in the Treatment of Tension Headache

Seymour Solomon," Arthur Elkind, + Fred R. Michael Gallaqher,"


Kenneth Bernard Swerdlow; Stanley Malkin *

SYNOPSIS ily vascular in nature and distinct from other forms


One hund red patients were enrolled in a multicenter double­ of head pain disorders.' However, thi s concept is not
blind study to evaluate the safety and effectiveness of the as widely held today and is gradually giving way to
Suppressor Unit, a cranial el ectrotherapy stimulator fo r the
symptomatic treatment of tension headach es , Treatment con ­
the vi ew th at tension headache and m igra ine may
sisted of extremely low leve l, high frequency current applied have a common underlying physiologic basis. The
transcranially. Pain scores before and aher 20 minute treat­ so called "c entral hypothesis" holds that the distinct
ments of individual headaches as well as patient and physician sy m ptoma tic app earance of headache is reflective
global evaluations were the primary efficacy variables. Follow­ of a central disturbance of neurochemica l/receptor
ing use of the active unit, patients reported an average reduc­
tion in pain of app roximately 35%. Placebo patients fu nction and related physiological events within the
reported a reduct ion of approximately 18%. The difference wa s upper brain stem, limbic, and/or hypothalmic
statistically significant (p = 0.01l. The active unit was rated as reqions .' Th e term "mixed headache syndrome"
moderately or highly in 40% by physicians. and in refers to a condition in which features of both
36% by patients . Both physicians and patients scored the
migraine and tens ion headache occur together. This
placebo unit moderately or highly effective for only 16%. The
difference in ordered outcomes was statistically significant obs ervat ion and stud ies challenging the traditional
(p =0.004). Approximat ely of in each group linkage of headache symptoms to blood flow or mus­
reported at least one minor adverse experience. Cranial elec­ c le statu s have lent support to the central hypothesis.
trotherapy stimulation is distinct from TENS , and is s afe and Evidenc e has been presented indicating a transfor­
ohen effective in a m elio rat ing the pain intensity of tension
headaches. It should be considered as an alternative to the
mation of interm itt ent migraine int o chronic daily
chronic usage of analgesics. headache:":' t hese headaches are often associated
with anal gesic abuse . The changi ng vi ew of tension
(Headache 29:445-450, 1989 ) headache been associated with a reevaluation
of trad itional t reatm ent conc epts which relied heav­
INTRODUCTlON ily of analgesic compounds including narcotics. Cur­
Recurring head pain is the m ost common pain rent prop hylactic pharmacologic treatments reflect
ailment. It is estimat ed that up to 50 millio n peo ple the influence of the central hypothesis. Tricyclic anti­
in the United States suffer fr om some form of head­ depressants are known to be centrall y active analge­
ache. According to recent surveys, almost 70% of sics and are commonly prescribed for headache suf­
American fam ilies have at least one member who ferers.
suffers from headac he.' Although the benefit of pharmacologic treatment
The primary headache disorders are migraine , for patie nts with tension headaches cannot be
cluster headache , and ten sion (mu scle contra ction ) doubted, complications due to overuse of medica­
headache. In 1962 the Ad Hoc Committee on the tions is a problem. As a result, there has been
Class ification of Headache focus ed on sym ptom­ a growing emphasis toward nonpharmacologic
specifi c types and considere d m igrain e to be pr imar­ treatments such as biofeedback, counseling and
phys ical th erapeutic measures." A recent addition to
• New York. NY the nonp harmac ologic treatments of headache is
Mount Vernon, NY the use of tran scutane ous electr ical nerv e stimula­
Chicago , IL ti on (TENS) applied to the cranium ." " While these
o Moorestown . NJ st udies report ed a degree of effectiveness, TENS
o Winter Park. FL

Repr int requests to : S eymour Solomon . M.D.• Direct or, Head­

units carry a th eoretical risk, as these devices often


ache Unit, Montefiere Medical Center, 111 East Street,
deliver substantial amounts of low-frequency electri­
Bronx. NY 10467
cal energy, ave ragi ng between 40-80 mA. 12 Aside
Accepted for Publication: May 3, 1989.
from the potential tactile discomfort, the safety of

HEADACHE PAGE

ohen effective in a m elio rat ing the pain intensity of tension


.
headaches. It should be conside red as an alternative to the
mation of inte rm itt ent migraine int o chronic daily
chronic usage of analgesics. headache:":' t hese headaches are often associated
... __.-. L __ . .
4 mA. The pulse wa s repeated at a frequency of Head ache severit y scor es w ere analyzed usin g the
15,000 Hz for 50 m s. Tn e ms pulse train had a foll owing models: 1) analyses chan ces
repetition rate of 15 Hz. The signal is further and of percent chanc es from baselin e in headache
described in Figure 1. severity sco res, using a one- way analy sis of varia nce
C u r r cu t
with t reatmen t as th e fact or and baseline score s as
th e covari at e; 2) an alyses of changes from bas eline
in head ache sever ity scores, using a two-way anal­
ysis of variance with treatment and investigator as
1 i cd J6 the fact ors.
I ' Safety Evaluations. Tabulati ons we re m ad e for the
t
prevalen ce of adv erse events." The propo rt ion of
patient s reporting adverse events were

, :, : __
between treatment gro ups using Fisher's Exact tests.
RESULTS
One hundred and twelve patient s (57 act ive and
o
55 placebo) used the unit during the study. Becau se
Fig. 1- Electric current waveform of the Cranial Electrotherapy of various prot ocol violation s, twe lve patients ha d
Stimulator manufactured by Pain Suppression Labs, Inc. no evalua ble head aches . Th is reduced the number
Wayne, New Jersey 07470. of evaluable pat ient s to 100, active and 50
placebo.
A perfectly blinded study when using a stimulat­ Patient Characteristics. Th ere wer e no significant
ing instrument as a therap eutic agent is not possible. differences betwe en tre atment groups for
The placebo unit ran for 70 seconds before shutting tions of sex, or race. Age s ranged from 20 to
off but the current meter registered 1.0-4.0 mA for 70 years with a mean age of 41 for pati ents in the
20 minutes, the same as the active unit. Patients placebo group and 42 for patients in the active group.
were to ld that the sensation initially experienced Likewise there we re no significant
might disappear after about one minute or might between tr eatment groups for di agnosis.. average
last the full 20 minutes ; in any case, the electrodes severity, or avera ge num ber of headaches per
were to be maintained for the full 20 minutes. month. A majority of the patients in the active qroup
Although patients were informed that they might (52%) had headaches of 12-24 hours in average d ur a­
receive a placebo unit, they did not know that the tion, while a m ajority of pati ents in th e pl acebo
unit turning off after 70 seconds of stimulation was group (54%) had headaches of less than 12 hours
to be the placeb o unit. in duration. The distributions of average duration of
Primary Efficacy Variables. Efficacy was based on headaches, categorized as less than 12 hours,
the g loba I evaluations of crania I electrothera py hours, an d grea ter than 24 hours , w ere significan tl y
units by the pat ients and the investigators, and on different (p = 0.004).
the reduction in headache severity scores after treat­ Global Evaluations. Globa l evaluations of t he
ment. The global evaluati ons were classified as effectiveness of the unit by the patients and inves­
"highly effective, " "moderately effecti ve," "min i­ tigators are summ arized in Table 1. In th e active
mally effective," and " not effective." Headache sev­ group 36% of the pati ents evaluated th e unit as
erity was rated by ci rcling an integer score on an "highly effective" or " moderatel y
analog pain scale ranging fr om 0 (no pain) to 10 whereas only 16% of. pati ents in the plac ebo group
(maximum pain) . so evaluated the unit. Sixty-three perc ent of
Statistical Methods. A ll hypothesis tests were per ­ pat ients in the olacebo qroup evaluate d th e as
formed using The Statistical Analys is Svst ern." All "not effective, " compared to on ly 38% of th e patie nts
P-values were based on two-tailed tests. Global in the active gr oup. There was a signifi cant difference
evaluations were compared between treatment betwe en treatment group s in the ord ered outcome s
g ro u ps using a catego rical dat a procedure." The for the patient g lo ba l evaluati ons (p = 0.006). The
ordered nature of the responses listed abo ve was investigator 's evaluation s were sim ilar to the
accounted for by using the RESPONSE function wi t h patient s' evalu ations.
scores 3, 2, and 0, respectively. Headache Severity Scores . Statistics for
For each hea dache , the change fr o m baseline in from pre -treatment to post-treatment in heada che
headache severity scores calculated using th e severity scores are given in Table 2. The m ean
sco re pri or to tr eatm ent and th e last post-treatme nt ity scor e by 2.1 foll owing use of the act ive
score. Av erages over multiole evaluable headaches unit and by 1. 2 use of th e pl acebo u nit.
were calculated t o give a single pre-treatment and This difference statistically sign ifi cant (p =
post-treatment severity score for each pati ent. Head­ 0.016). Anal ys is of perc ent age change fr om pre-treat­
ache s were considered non-evaluabl e if one or m ent scores w as also stat istica lly sign ifi cant, (p =
protoc ol violat ion was evid ent. 0.011 ); treatm ent w ith th e active un it produce d an
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to be the placeb o unit. In duration. I he distributions at average duration at


Primary Efficacy Variables. Efficacy was based on headaches, categorized as less than 12 hours,
a loba I evaluations of crania I elec trothera DV hours. and area t er than 24 hours . we re sianificantl v
Table 4 ou ter co rt ex of the skull, subcutane ous tissue and
Summ ary of Prematur e Ter m in ation s ski n . By sim u lating the moistened spo nge electr od es
o n the m odel and sol ving Lapl ace's equ ation s, the
Nu m ber o f Pat ie n ts
ele ctri c fiel d and cu rrent dens ity w ere determined
Reaso n for Uni t Pl acebo Un it
in each ti ssue compartment .
A dve rs e 2 ( 4% ) 2
In this simu lated mod el with an applied current
Lack of T nera oe u t ic 3 3 ( 5%1
­ at the ext ern al ele ctr ode su rface , soluti on of the equ
N on- Compliance 1 1
at io ns sh owe d : 1} relati vel y hi gh ele ctric fi eld s in the
Oth er 4 1
co rt ical bone , 2) incre ased current den sit y in the CSF,
10 7 (13% ) 3) increa sed current density in the outer surface of
the b rai n that fa lls off toward the interi or, and 4) a
u ses analgesi c medications. Panernin g in the se
u niform electri c field in the bulk o f brain tis sue. At
patients is so that the ingestion of analgesics
a to t al current flo w of 1 the current density in
­
in re sp o nse to a hea dache ma y be Reduc th e brain ran ged from 5 to 18 per crn .t Th e elect ri c
ti on o f analges ic med icati on is o ft en a g oal fi eld in the brain ranged from 2.8 to 8 mV per ern.'
in the treatment of ch ro nic heada che patient s. The The highest cu rrent densities and electric fields in
use of a nonoharma col og ic moda lity is a welcome
th e brain we re concentrated at th e cortical surfa ce."
addition to current treatment appro ach es.
Thi s is co ntrasted w it h procedures that stimulate
A s shown in Tab le 3 th ere w as not a sign ificant
the brain with direct current. Invasi ve pro cedure s
difference in the inci denc e of ad verse events
have been used to control severe and intractable
between the treatment g rou ps for any of the
p ain by di rect ly stimu lat ing th e peri ventricular and
reporte d symptoms . A sma ll percent age. of pat ients,
peria qu edu ctal gre y matter v ia permanen t ly
3 .5% (2/57), developed a slight
imp lanted electrodes ."? Wh ile the model
­
respon se to applied cu rrent. Th is is a co m mo n obse r
indicates that th ese areas of the brain are stimul ated
vat io n for devi ces that co up le elec tr ic field s to the
by the noninvas ive technique, the current levels are
skin v ia surfa ce electrode s. In this st u dy, sponge
bet ween o ne and two or ders of ma gnitud e less than
electrodes were moistene d with ordinary tap water
tho se deli vered by direct stimulati on techniques.
­
t o pro v ide a co nductiv e br idg e. A lte rn at ively, a com
Why and extremel y w eak cu rrents produ ce
mercial co nd uctive gel elect rode coul d be used .
­ biological activity has been the sub ject of much co n
These findi nas of safety are consistent w it h the
lect u re since t he findin g that weak currents promote
exten siv e by the Nat ional Resear ch Council
w o u nd heal ing responses of both soft tis sue and
regarding crani al electrothe rap y stirnu lat ors .vin that
From thi s w o rk has em erged the
­
rep o rt, w hich con sist ed of a review of low level cra
of "frequency " and "amplitude" w indows of
nial stimu lation , no evidence of Important side
­ therapeut ic etficacv." :" Apparentl y, low level cur
effects was fo un d.
rents on the order of 1-20 p er ern - either direct
This cranial electrotherapy stimulator is not to be
current or m odula t ed at extrem ely low frequ encies
confu sed w ith TEI\JS. TENS is a low frequency, high
­ of 0-100 Hz, intera ct w it h cell membranes in a man
cu rre nt moda lity t hat pro vi des pu lse s of current at
­ ner that pr oduce s mod ifications in in fo rm ati o n tran s
fr equenci es of 200 Hz or less , w it h intensit ies that
du ction associated with the cla ssical second
­
range int o the hu ndreds of Th e Pain Suppre s
sen ger pat hways, calc ium channels and cycl.ic
sor, on the hand, gen erates a high fr equency
The pu lse repet ition rate (15 Hz) used in
carrier sig n al at iow voltag e (Figu re l ). A capacitor
this st ud y and the current den sit y at the co rt ica l
­
has charact erist ic of pa ssmo cu rr ent at high fre
su rf ace as given by the computer m od el fall
que ncy, and the skin has this capac itiv e comp onent ."
these biologically acti ve windows. A s an alternative
Th e high frequ ency of the Pain Suppress or allows
co ncept the resp o nses seen in th is study ma y be
th e current f low to de ep tis sues at relati vel y low
rela ted to the g ate th eory of pain . Acco rding to th is
­
vol t ao es : th ere is a hig h effici ency of power d epos i
the ory, sensati on on th e sk in st imu lat es del ta fiber s
t ion tissues. TENS howe ver, have
whi ch act to close the putative pain Whatever
low efficie ncy of deep tiss ue st im u lat io n si nce the
­ the m echan ism f u rt her invest ig at io n of th e relat ion
­
low fr equency o utp ut primar ily m eets the hi gh resi st
­ sh ip bet ween mil d cran ial ele ctr othera py and neuro
an ce of the skin. Hen ce. h igh voltage is ne eded to
tr ansm itter acti v it y is wa rranted .
d rive curren t th rough the skin .
­ It ap pears that th is no ni nva sive cran ial e.lectr o
To determi ne the elect ric fi eld and cur rent density
therapy st imula tor is safe , an d shou ld be considered
through th e scalp and the sku ll t he fi n ite element
­ In t h e of te nsio n hea d ache as alte r
meth od in a com put er sim ulate d m odel of cranial
nati ve to th e us age of anal q esi cs
­
elect rotherapy stimuia ti on has b een us ed to con
REFERE NCES
st ruct an approxim ate t hree dim ens ional
1 Sao er J R: Hea dac he Diso rd ers - Cur ren t and
mod el of the Th e m ode l con sist ed Tr eatm en t St rateg ies. John Wrig ht PGS Boston, 19S3 .
­
of co nc entr ic sphe res com pri sin g the bra in, cere 2. Ad
­ Ho c Comm itt ee o n Class i ficat io n of Class i fi
br ospin al fluid (CSF), inn er co rtex of th e skul l, diploe, ca t io n of He ad ach es. J AMA 179-7 17-71 8, 1962

HE ADA CHE PAGE 44 9

-
­
report , whi ch co n sistec or a revie w ot low level cra
of "freque ncy" and "amplitude" w indows of
nial stimu lation , no ev idence of important side
therapeut ic etficacv." :" Apparentl y, low level cur-
effects was fo und .