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Safety and Effectiveness of Cranial Electrotherapy in the Treatment of Tension Headache

Seymour

Solomon," Arthur Elkind, + Fred

Seymour Solomon," Arthur Elkind, + Fred R. Michael G allaqher,"

R. Michael Gallaqher,"

Kenneth

Bernard Swerdlow; Stanley Malkin *

Bernard Swerdlow; Stanley Malkin *

SYNOPSIS One hund red patients were enrolled in a multicenter double­

blind study to evaluate the safety and effectiveness of the Suppressor Unit, a cranial el ectrotherapy stimulator fo r the symptomatic treatment of tension headach es , Treatment con ­

sisted of extremely low

transcranially. Pain scores before and aher 20 minute treat­ ments of individual headaches as well as patient and physician global evaluations were the primary efficacy variables. Follow­ ing use of the active unit, patients reported an average reduc­ tion in pain of app roximately 35%. Placebo patients reported a reduct ion of approximately 18%. The difference wa s statistically significant (p = 0.01l. The active unit was rated as moderately or highly in 40% by physicians. and in 36% by pat ients . Both physicians and pat ients scored the placebo unit moderately or highly effective for only 16%. The difference in ordered outcomes was statistically significant (p =0.004). Approximat ely of in each group reported at least one minor adverse experience. Cranial elec­ trotherapy stimulation is distinct from TENS , and is s afe and ohen effective in a m eliorat ing the pain intensity of tension headaches. It should be considered as an alternative to the chronic usage of analgesics.

ed as an alternative to the chronic usage of analgesics . leve l, high frequency current

leve l, high frequency current applied

of analgesics . leve l, high frequency current applied (Headache 29:445-450, 1 989) INTRODUCTlON Recurring head
of analgesics . leve l, high frequency current applied (Headache 29:445-450, 1 989) INTRODUCTlON Recurring head
of analgesics . leve l, high frequency current applied (Headache 29:445-450, 1 989) INTRODUCTlON Recurring head
of analgesics . leve l, high frequency current applied (Headache 29:445-450, 1 989) INTRODUCTlON Recurring head

(Headache 29:445-450, 1989)

INTRODUCTlON

Recurring head pain is the m ost common pain ailment. It is estimat ed that up to 50 millio n peo ple in the United States suffer fr om some form of head­ ache. According to recent surveys, almost 70% of American fam ilies have at least one member who suffers from headac he.'

disorders are migraine ,

cluster headache , and ten sion (mu scle contra ction ) headache. In 1962 the Ad Hoc Committee on the Class ification of Headache focused on sym ptom­ specifi c types and considere d m igrain e to be pr imar­

The

primary headache

New York. NY

Mount Vernon, N Y Chicago , IL

Mount Vernon, NY Chicago , IL

o

Moorestown . NJ

Winter Park. FL Repr int requests to : S eymour Solomon . M.D.Direct or, Head­ ache Unit, Montefiere Medical Center, 111 East Street, Bronx. NY 10467 Accepted for Publication: May 3, 1989.

o

Bronx . NY 10467 Accepted for Publication: May 3, 1989. o HEADACHE ohen effective in a

HEADACHE

ohen effective in a m eliorat ing the pain intensity of tension headaches. It should be conside red as an alternative to the chronic usage of analgesics.

ily vascular in nature and distinct from other forms

of

head pain disorders.' However, thi s concept is not

as

widely held today and is gradually giving way to

the vi ew th at t ension heada che and m igra ine may have a common underlying physiologic basis. The so called "c entral hypothesis" holds that the distinct sy mptomatic appearance of headache is reflective of a central disturbance of neurochemica l/receptor function and related physiological events within the upper brain stem, limbic, and/or hypothalmic reqions .' Th e term "mixed headache syndrome"

refers to a condition in which features of both migraine and tens ion headache occur together. This obs ervat ion and stud ies challenging the traditional linkage of headache symptoms to bl ood flow or mus­ c le statu s have lent support to the central hypothesis. Evidence has been presented indicating a transfor­ mation of intermitt ent migraine into chronic daily headache:":' t hese headaches are often associated with anal gesic abuse . The changing vi ew of tension headache been associated with a reevaluation

ew of tension headache been associated with a reevaluation of trad itional t reatm ent conc

of

trad itional t reatm ent conc epts which relied heav­

ily

of analgesic compounds including narcotics. Cur­

rent prop hylactic pharmacologic treatments reflect the influence of the central hypothesis. Tricyclic anti­ depressants are known t o be centrall y active analge­ sics and are commonly prescribed for headache suf­ ferers.

Although the benefit of pharmacologic treatment for patie nts with tension headaches cannot be doubted, complications due to overuse of medica­ tions is a problem. As a result, there has been

a growing emphasis toward nonpharmacologic

treatments such as biofeedback, counseling and phys ical th erapeutic measures." A recent addition to

ical th erapeutic measures." A rec ent addition to the n onp harmac ologic treatments of

the

nonp harmac ologic treatments of headache is

the

use of tran scutane ous

electrical nerv e stimula­

ti on (TENS) applied to the cranium ." " While these studies report ed a degree of effectiveness, TENS units carry a th eoretical risk, as these devices often deliver substantial amounts of low-frequency electri­ cal energ y, a ve ragi ng between 40- 80 mA. 12 Aside from the potential tactile discomfort, the safety of

.

PAGE

the potential tactile discomfort, the s afety of . PAGE mation of in termitt ent migraine

mation of intermitt ent migraine into chronic daily headache:":' t hese headaches are often associated

-.

L

.

.

4 mA.

15,000

repetition

described in Figure 1.

The

pulse wa s repeated at a frequency of

50 m s. Tn e

of

15

wa s repeated at a frequency of 50 m s . Tn e of 15 ms

ms pulse train had a

further

Hz. The

signal

is

Hz for

rate

C u r r cu t

,,:,,:

1 i cd J 6 I ' t o
1 i cd
J 6
I
'
t
o

Fig. 1- Electric current waveform of the Cranial Electrotherapy Stimulator manufactured by Pain Suppress ion Labs, Inc. Wayne, New Jersey 07470.

A perfectly blinded study when using a stimulat­

possible.

The placebo unit ran for 70 seconds before shutting off but the current meter registered 1.0-4.0 mA for 20 minutes, the same as the active unit. Patients were to ld that the sensation initially experienced might disappear after about one minute or might last the full 20 minutes ; in any case, the electrodes were to be maintained for the full 20 minutes. Although patients were informed that they might receive a placebo unit, they did not know that the unit turning off after 70 seconds of stimulation was to be the placeb o unit.

ing instrument as a therap eutic agent is not

Primary Efficacy Variables. Efficacy was based on the g loba I evaluations of crania I electrothera py units by the pat ients and the investigators, and on

py units by the pat ients and the investigators, and on Head ache se ve rit

Head ache severit y scores w ere analyzed usin g the foll owing mod els: 1) analyses chan ces and of percent chanc es from baselin e in headache

severity scores, using a one- way analy sis of varia nce

with t reatmen t as th e fact or

th e covari ate; 2) an alyses of changes from bas eline

scores, using a two-way anal­

ysis of variance with treatment and investigator as the fact ors. Safety Evaluations. Tabulati ons we re m ade for the prevalen ce of adv erse events." The propo rt ion of patient s reporting adverse events were between treatment groups using Fisher's Exact tests.

RESULTS One hundred and twelve patient s (57 act ive and

55 placebo) used the unit during the study. Becau se

of various prot ocol violation s, twe lve patients ha d no evaluable head aches. Th is reduced the number of evaluable pat ient s to 100, active and 50 placebo. Patient Characteristics. Th ere wer e no significant differences between tre atment groups for

tions of sex, or

and baseline score s as

f or tions of se x, or a nd ba sel ine score s a s
f or tions of se x, or a nd ba sel ine score s a s

in head ache sever ity

or a nd ba sel ine score s a s i n head ache se ver
or a nd ba sel ine score s a s i n head ache se ver
or a nd ba sel ine score s a s i n head ache se ver
or a nd ba sel ine score s a s i n head ache se ver

race. Age s ranged from 20 to

70 years with a mean age of 41 for pati ents in the

placebo group and 42 for patients in the active group.

Likewise there we re no

between tr e atment group s for di agno sis

severity, or average number of headaches per month. A majority of the patients in the active qroup (52%) had headaches of 12-24 hours in average d ura­ tion, while a m ajority of pati ents in th e pl acebo group (54%) had headaches of less than 12 hours in duration. The distributions of average duration of headaches, categorized as less than 12 hours, hours, an d grea ter than 24 hours , w ere significan tly different (p = 0.004).

significant

si gnifican tly d ifferent (p = 0 . 004). sig nificant a v erage the

av erage

tly d ifferent (p = 0 . 004). sig nificant a v erage the reduction in

the reduction in headache severity scores after treat­ ment. The global evaluati ons were classified as "highly effective, " "moderately effecti ve," "min mally effective," and " not effective." Headache sev­ erity was rated by ci rcling an integer score on an

Global Evaluations. Globa l evaluations of t he effectiveness of the unit by the patients and inv es­ tigators are s umm arized i n Table 1. In th e ac tive group 36% of the pati ents evaluated th e unit as "highly effective" or " moderatel y

th e ac tive group 36% of the pati ents e valuated th e unit as
th e ac tive group 36% of the pati ents e valuated th e unit as

analog pain scale ranging

fr om

0

(no

pain) to

10

whereas only 16% of. pati ents in the plac ebo g roup

(maximum pain) . Statistical Methods. A ll hypothesis tests were per ­

Methods . A l l h ypothesis tests were per ­ were calculated t o give
Methods . A l l h ypothesis tests were per ­ were calculated t o give

were calculated t o give a single pre-treatment and

post-treatment severity score for each pati ent. Head­

­ were calculated t o give a s ingle pre-treatment and post-treatment s everity score f

so evaluated the unit. Sixty-three perc ent of pat ients in the olacebo qroup evaluated 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 roups using a catego rical data procedure." The

for the patient g lobal evaluati ons (p = 0.006). The

ordered nature of the responses listed abo ve was accounted for by using the RESPONSE function wi th scores 3, 2, and 0, respectively. For each hea dache , the change fr om baseline in headache severity scores calculated using th e sco re pri or to tr eatm ent and th e last post-treatme nt score. Av erages over multiole evaluable headaches

ache s were considered non-evaluabl e if one or protoc ol violat ion was evid ent.

investigator's evaluation s were sim ilar to the patient s' evalu ations. Headache Severity Scores . Statistics for

from pre -treatment to post-treatment in heada che sever ity scores are given in Table 2. The m ean

ive

nit.

This difference statistically sign ificant (p = 0.016). Anal ys is of percentage change fr om pre-treat­

Anal ys i s o f p ercentage ch ange fr om pre-treat­ ity s cor
Anal ys i s o f p ercentage ch ange fr om pre-treat­ ity s cor

ity s cor e by 2 .1 f oll o wing u se of the act unit and by 1. 2 u se of th e pl acebo u

of the act unit and by 1. 2 u se of th e pl acebo u

m

0.011 ); treatm ent

ent scores w as

also stat istica lly sign ificant, (p w ith th e active un it produce d an

=

HEADACHE

PAGE

PAGE

to be the placeb o

unit.

Primary Efficacy Variables. Efficacy was based on

crania I elec trothera DV

a loba I evaluations of

In duration. I he distributions at average duration at headaches, categorized as less than 12 hours, hours. and area ter than 24 hours . we re sianificantl v

a t headaches, categorized as le ss than 12 hours, hours . a nd area ter

Table 4

Summ ary of Prematur e Ter m in ation s

Reaso n for

A dvers e

Lack of T neraoeutic

in ation s Reaso n f or A dvers e L ack o f T neraoeutic

Non- Compliance

Oth er

A dvers e L ack o f T neraoeutic N on- Compliance Oth er N um

Num ber

Unit

o f T neraoeutic N on- Compliance Oth er N um ber Uni t o f
o f T neraoeutic N on- Compliance Oth er N um ber Uni t o f

o f Patie nts

Pl acebo Un it

2

3

1

4

( 4% )

( Uni t o f P atie nts Pl acebo Un it 2 3 1 4 ( Uni t o f P atie nts Pl acebo Un it 2 3 1 4 ( Uni t o f P atie nts Pl acebo Un it 2 3 1 4 (

2

3

1

1

f P atie nts Pl acebo Un it 2 3 1 4 ( 4 % )

5%1

10

(13% ) 13% )

7

ses analgesi c medications. Panernin g in the se patients is so that the ingestion of analgesics

u

the se patients is so that the ingestion of analgesics u in re sp onse t

in re sp onse to a

ti on o f analges ic

in the treatment of chro nic heada che

hea dache ma y be Reduc­

of c hro nic heada che hea dache ma y be R educ­ med icati on

med icati on is o ften a g oal

patient s. The

use of a nonoharma col og ic moda lity is a welcome addition to current treatment appro ach es. A s shown in Tab le 3 th ere w as not a sign ificant difference in the incidence of ad verse events between the treatment g rou ps for any of the reporte d symptoms . A sma ll percent age. of pat ients, 3 .5% (2/57), developed a slight

respon se to applied cu rrent. Th is is a co m mo n obse r­ vatio n for devi ces that coup le elec tr ic field s to the skin v ia surfa ce electrode s. In this study, sponge electrodes were moistene d with ordinary tap water t o pro vide a co nductiv e br idg e. A lte rnatively, a com­ merc ial conductive gel elect rode coul d be used . These findi nas of safety are consistent w ith the exten sive by the Nat ional Research Council regarding crani al electrothe rapy stirnu lators .vin that report, w hich con sisted of a review of low level cra­ nial stimu lation , no evidence of Important side

effects was foun d.

This cranial electrotherapy stimulator is not to be confu sed w ith TEI\JS. TENS is a low frequency, high

current moda lity t hat pro vi des pu lse s of current at

fr equen cies of 200 Hz or less , w ith intensities that

cies o f 20 0 H z or less , w ith i ntensities that range
cies o f 20 0 H z or less , w ith i ntensities that range
cies o f 20 0 H z or less , w ith i ntensities that range
cies o f 20 0 H z or less , w ith i ntensities that range

range int o the hu ndreds of Th e Pain Suppre sor, on the hand, gen erates a high fr equency carrier signal at iow voltag e (Figure l ). A capacitor has characterist ic of pa ssmo current at high fre­ que ncy, and the skin has this capac itiv e comp onent ." Th e high frequ ency of the Pain Suppress or allows th e current f low to de ep tis sues at relati vely low vol taoes : th ere is a high effici ency of power d epos i­

th ere i s a h igh effici ency of p ower d epos i­ t
th ere i s a h igh effici ency of p ower d epos i­ t
th ere i s a h igh effici ency of p ower d epos i­ t
th ere i s a h igh effici ency of p ower d epos i­ t

t ion tissues. TENS howe ver, have low efficie ncy of deep tissue stim ulatio n si nce the low fr equency o utp ut primar ily m eets the hi gh resi st­ an ce of the skin. Hen ce. h igh voltage is ne eded to d rive current th rough the skin . To determi ne the electric fi eld and cur rent density

thr ough th e scalp and the

skull t he fi nite element

meth od in a com put er sim ulated m odel of cranial elect rotherapy stimuia tion has b een us ed to con­ st ruct an approxim ate t hree dim ens ional

mod el of the

bra in, cere­

br ospin al fluid (CSF), inn er co rtex of th e skul l, diploe,

of co nc entr ic spheres com pri sing the

l , diploe, of co nc entr ic s pheres c om pri sing the Th
l , diploe, of co nc entr ic s pheres c om pri sing the Th
l , diploe, of co nc entr ic s pheres c om pri sing the Th

l , diploe, of co nc entr ic s pheres c om pri sing the Th

Th e m ode l con sist ed

HE ADA CHE

report , whi ch co nsistec or a revie w ot low level cra­

nial stimu lation , effects was found .

side

no

ev idence

of

important

ou ter cort ex of the skull, subcutane ous tissue and ski n. By sim ulating the mo istened spo nge electrod es

o n the m odel and sol ving Lapl ace's equ ation s, the ele ctri c fiel d and cu rrent dens ity w ere determined in each ti ssue compartment .

In this simu lated mod el with an applied current

ele ctr ode su rface , soluti on of the equ­

atio ns sh owe d : 1} relati vely hi gh ele ctric fi elds in the

cort ical bone , 2) incre ased current den sity in the CSF, 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 niform electri c field in the bulk o f brain tis sue. At

a

to tal current flo w of 1 the current density in th e brain ran ged from 5 to 18 per crn .t Th e electri c

fi eld in the brain ranged from 2.8 to 8 mV per ern.' The highest cu rrent densities and electric fields in th e brain we re concentrated at th e cortical surfa ce." Thi s is co ntrasted w ith procedures that stimulate the brain with direct current. Invasi ve pro cedure s have been used to control severe and intractable

th e peri ventricular and

at the ext ern al

th e peri ventricular and a t t he e xt ern al p ain by

p ain by di rect ly stimu lat ing

peria qu edu ctal gre y matter v ia permanen t ly imp lanted electrodes ."? Wh ile the model indicates that th ese areas of the brain are stimul ated by the noninvas ive technique, the current levels are bet ween o ne and two or ders of ma gnitud e less than tho se deli vered by direct stimulati on techniques.

se deli vered b y dire ct stimulati on techni ques. Wh y and extremel y
se deli vered b y dire ct stimulati on techni ques. Wh y and extremel y

Wh y and extremel y w eak currents produ ce biological activity has been the sub ject of much co n­ lecture since t he findin g that weak currents promote

w ound heal ing responses of both soft tis sue and

From thi s w ork has em erged the of "frequency " and "amplitude" w indows of therapeut ic etficacv.":" Apparentl y, low level cur­ rents on the order of 1-20 p er ern- either direct

rents o n the order of 1-20 p er e rn- e ither direct current or
rents o n the order of 1-20 p er e rn- e ither direct current or
rents o n the order of 1-20 p er e rn- e ither direct current or

current or m odula ted at extrem ely low frequ encies of 0-100 Hz, interact w ith cell membranes in a man­

ner that

du ction associated with the cla ssical second sen ger pat hways, calc ium channels and cycl.ic

The pulse repet ition rate (15 Hz) used in this st ud y and the current den sit y at the co rtical surface as given by the computer m odel fall these biologically acti ve windows. A s an alternative co ncept the resp onses seen in th is study ma y be rela ted to the g ate th eory of pain . Acco rding to th is

the ory, sensati on on th e sk in stimu lates del ta fiber s whi ch act to close the putative pain Whatever the m echan ism f urther investigatio n of th e relat ion­ sh ip bet ween mil d cranial ele ctr othera py and neuro­ tr ansm itter acti v ity is wa rranted . It ap pears that th is noni nva sive cranial e.lectr o­ therapy st imula tor is safe , an d shou ld be considered In t he of te nsio n hea dache as alte r­ nati ve to th e us age of anal qesics

pr oduce s mod ifications in informati on tran

pr oduce s mod ifications in i nformati on tran s­ REFERE NCES 1 S aoer
pr oduce s mod ifications in i nformati on tran s­ REFERE NCES 1 S aoer
pr oduce s mod ifications in i nformati on tran s­ REFERE NCES 1 S aoer
pr oduce s mod ifications in i nformati on tran s­ REFERE NCES 1 S aoer
pr oduce s mod ifications in i nformati on tran s­ REFERE NCES 1 S aoer
pr oduce s mod ifications in i nformati on tran s­ REFERE NCES 1 S aoer

REFERE NCES

1 Saoer

ifications in i nformati on tran s­ REFERE NCES 1 S aoer 2. J R: Hea

2.

J R:

Hea dac he

Diso rders -

Cur rent

NCES 1 S aoer 2. J R: Hea dac he D iso rders - Cur rent

and Boston, 19S3 .

Tr eatm en t St rateg ies. John Wrig ht PGS

Ad Hoc Comm itt ee o n Class ificat io n of ca tio n of He ad ach es. J AMA 179-7 17-71 8, 1962

Class ifi­

PAGE 44 9

 

-

of

"freque ncy"

and

"amplitude"

w indows

of

therapeut ic

etficacv.":"

Apparentl y, low

level

cur-