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  • 8/9/2019 Electrotherapy for pain relief: does it work? A laboratory-based study to examine the analgesic effects of electroth

    1/11

    E l e c t r o t h e r a p y f o r p a i n

    r e l i e f : d o e s i t w o r k ?

    A la b o r a to r y b a s e d s tu d y

    t o e x a m i n e t h e a n a l g e s i c

    e f f e c t s o f e l e c t r o t h e r a p y o n

    c o l d i n d u c e d p a i n i n h e a l t h y

    i nd iv idua ls

    G T a b a s a m a n d M I J o h n s o n

    G h a z a l a T a b a s a m

    Partt ime Lecturer in

    Heal th Sc iences, D r Ma rk

    I .Johnson Pr inc ipa l

    Lecturer- n Hum an

    Physiology, Schoo l o f

    Health Sciences, Faculty of

    Heal th and Environment,

    Leeds Metropolitan

    University, Calverley S treet,

    Leeds LSI 3HE, UK

    Correspondence to:

    GhazalaTabasam

    I n t e r f e r e n t i a l c u r r e n t s I F C ) a r e a t y p e o f t r a n s c u t a n e o u s e l e c t ri c a l n e r v e s t i m u l a t i o n

    T E N S ) a n d a r e p r e d o m i n a n t l y a d m i n i s t e r e d f o r t h e m a n a g e m e n t o f p a i n, h o w e v er ,

    t h e re i s l i t t l e o b je c t i ve e v id e n ce t o su p p o r t t h e i r c l i n i ca l e f f e c t i ve n e ss .Th is p a p e r

    d e m o n s t r a t e s t h e v a l u e o f l a b o r a t o r y -b a s e d s t u d ie s i n th e i n i t i a l a s se s s m e n t o f t h e

    a n a lge s ic e f f e c ts o f a n e le c t ro th e r a p y a n d d iscusse s t h e f i n d in g s o f a s in g le b l in d

    p la ce b o -co n t ro l l e d s tu d y w h ich e x a m in e d t h e a n a lg e s ic e ff e c ts o f IFC o n co ld - in d u ce d

    p a in in 4 0 h e a l t h y in d iv id u a ls . Su b je c t s co m p le te d s i x cyc le s o f t h e co ld - in d u ce d p a in

    t e s t d u r i n g w h i c h t h e t i m e t o p a i n th r e s h o l d s ) a n d t h e s e lf r e p o r t o f p ai n i n t e n s i t y a n d

    p a in u n p le a san tn e ss 0 -1 0 c m V isu a l An a lo g u e S ca le) w e re re co rd e d . Su b je c t s w e re

    r a n d o m l y a l lo c a t e d t o r e c e i v e e i t h e r a c t i v e IF C o r s h a m I F C t r e a t m e n t d u r i n g

    th

    t h i r d a n d f o u r t h e x p e r i m e n t a l c y c l es . T w o -w a y r e p e a t e d m e a s u re s A N O V A w e r e

    p e r f o r m e d o n th e p e r c e n t a g e ch a n g e i n e a ch o u t c o m e m e a s u r e f r o m t h e p r e -

    t re a tme n t b a se l in e f o r e a ch su b je c t . R e su l t s sh o w e d t h a t IFC e le va te d p a in t h re sh o ld

    w h e n c o m p a r e d t o s h a m I F C d u r i n g tr e a t m e n t b u t n o t p os t t r e a t m e n t . T h e r e w e r e n o

    d i ff e re n c e s b e t w e e n t h e I F C a n d s h a m t r e a t m e n t g r o u p s fo r t h e p e r c e n ta g e c h a n ge i n

    p a in in te n s i t y a n d u n p le a sa n tn e ss ra t in g s . I t w a s co n c lu d e d t h a t IFC p ro d u ce d

    a n a lg e sic e f fe c t s w h ich w e r e g re a te r t h a n t h o se p ro d u ce d b y sh a m IFC fo r p a in

    t h r e s h o l d , b u t n o t f o r t h e p a in i n t e n s i t y a n d u n p le a s a n tn e s s r a t i n g s u n d e r t h e p r e s e n t

    e x p e r i m e n t a l c o n d i t i o n s . H o w e v e r , t h e s e ef fe c ts o n l y o c c u r r e d w h e n t h e s t i m u l a t o r

    w a s sw i t ch e d o n .Th e c l i n i ca l imp l i ca t io n s o f t h e se f i n d in g s a re d iscu sse d .

    Ke y w o rd s : i n t e r f e re n t ia l cu r re n t t h e ra p y , e le c t ro th e ra p y , p a in , a n a lg e s ia , co ld - in d u ce d

    p a in

    I N T R O D U C T I O N

    O v e r t h e l a s t f ew d e c a d e s t h e a d m i n i s t r a ti o n o f e l e c -

    t r o t h e r a p y f o r th e m a n a g e m e n t o f a v a r i e t y o f c l i n i -

    c a l c o n d i t i o n s h a s b e c o m e v e r y p o p u l a r ( P a x t o n

    1 9 8 0 , R o b i n s o n e t a l . 1 9 8 8 , L i n d s a y e t a l . 1 9 90 ,

    B a x t e r e t a l . 1 9 9 1 , P o p e e t a l . 1 9 9 5 ) . T h e o v e r a l l

    c o s t s t o t h e N a t i o n a l H e a l t h S e r v i c e o f p u r c h a s i n g

    n e w e l e c t r o th e r a p y e q u i p m e n t a r e i n t h e r e g i o n o f

    s m i l l i o n a y e a r w i t h a c a p i t a l i n v e s t m e n t o f s

    m i l l i o n ( I d e P a r t r i d g e 1 9 8 8 ). I t h a s b e e n e s t i m a t e d

    t h a t t h e r e a r e c u r r e n t l y m o r e t h a n 2 5 0 0 0 e l e c t r o t h e r -

    a p y d e v i c e s u s e d b y t h e N H S i n t h e U K ( P o p e e t al .

    1 9 9 5) . T w o o f t h e m o s t p o p u l a r e l e c t r o t h e ra p i e s

    l i n ic a l E f f e c ti v e n e s s i n N u r s i n g

    (I 999) 3, 14-24 9 1999 Harcourt Brace& Co. Ltd

  • 8/9/2019 Electrotherapy for pain relief: does it work? A laboratory-based study to examine the analgesic effects of electroth

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    e m p l o y e d b y t h e r a p i s t s in t h e U K a r e tr a n s c u t a -

    n e o u s e l e c t r i c a l n e r v e s t i m u l a t i o n ( T E N S ) a n d

    i n t e r f e r e n t i a l c u r r e n t t h e r a p y ( 1 F C ) .

    T E N S i s u s e d w i d e l y b y n u r s es a n d m i d w i v e s t o

    r e l i e v e p o s t o p e r a t i v e p a i n , l a b o u r p a i n a n d c h r o n i c

    p a i n ( R e e v e e t a l . 1 9 9 6 ) . T h e r e i s a v a s t l i t e r a t u r e

    o n T E N S , a l t h o u g h r e c e n t s y s t e m a t i c r e v i e w s s u g -

    g e s t t h at T E N S i s n o m o r e e f f e c t i v e th a n p l a c e b o

    f o r p o s t o p e r a t i v e p a i n ( C a r r o l l e t a l . 1 9 9 6 ) a n d

    l a b o u r p a i n ( C a r r o l l e t a l . 1 9 9 7 ) a n d i t s e f f e c t iv e -

    n e s s f o r t h e m a n a g e m e n t o f c h r o n i c p a i n i s a l s o a t

    p r e s e n t u n c l e a r ( R e e v e e t a l. 1 9 9 6 , G a d s b y

    F l o w e r d e w 1 9 9 7 ) .

    I F C i s a t y p e o f T E N S t h a t is u s e d p r e d o m i n a n t l y

    b y p h y s i o t h e r a p i s t s fo r t h e m a n a g e m e n t o f p a i n f u l

    c o n d i t i o n s . T o d a t e , n o s y s t e m a t i c re v i e w s h a v e

    b e e n p e r f o r m e d t o a s s e s s t h e c l i n i c a l e ff e c t i v e n e s s

    o f I F C . T h e I F C l i t e ra t u r e co n s i s t s o f m a n y u n c o n -

    t r o l l e d s tu d i e s a n d e f f e c t i v e n e s s i s b a s e d o n a n e c d o -

    t a l e v i d e n c e ( N i k o l o v a 1 9 67 , 1 9 8 7, N e l s o n 1 9 8 1,

    E i g l e r 1 9 7 9 ) .

    I t is c o m m o n s c i e n t if i c p r a c t i c e t o e v a l u a t e a n y

    n e w t r e a t m e n t , b e f o r e i m p l e m e n t i n g i t , a n d t o

    c a t a l o g u e i t s p o t e n t i a l b e n e f i t s a n d s i d e e f f e c t s a s

    w e l l a s i t s s u p e r i o r i t y o v e r e x i s t i n g t r e a t m e n t s .

    I n i t ia l i n s ig h t s i n t o t h e e f f e c t i v e n e s s o f a n a n a l g e s i c

    i n t e r v e n t i o n c a n c o m e f r o m l a b o r a t o r y - b a s e d

    e x p e r i m e n t s u s i n g h e a l t h y s u b j e c t s . A s i n g l e - b l i n d

    p l a c e b o - c o n t r o l l e d s t u d y w h i c h w a s p e r f o r m e d t o

    e x a m i n e t h e a n a l g e s i c e f fe c t s o f I F C i n 4 0 h e a l t h y

    v o l u n t e e r s u s i n g t h e c o l d - i n d u c e d p a i n t e c h n i q u e

    w i l l b e u s e d t o h i g h l i g h t t h e i m p o r t a n c e o f s u c h

    w o r k . T h e a i m o f t h is p a p e r i s t o d e m o n s t r a t e t h e

    v a l u e o f l a b o r a t o r y - b a s e d s t u d i e s i n t h e i n i t i a l

    a s s e s s m e n t o f a n a n a l g e s i c i n t e r v e n t i o n u s i n g a

    l a b o r a t o r y - b a s e d s t u d y a s a n e x a m p l e .

    B C K G R O U N D

    I F C a r e a t y p e o f T E N S a n d a r e u s e d p r e d o m i n a n t l y

    b y p h y s i o t h e r a p i s t s t o m a n a g e a r a n g e o f c l i n i c a l

    c o n d i t i o n s ( D e D o m e n i c o 1 9 87 , N i k o l o v a 1 9 87 ,

    S a v a g e 1 9 9 2, L o w R e e d 1 9 94 , M a r t i n 19 9 4 , P o p e

    e t a i. 1 9 9 5 ). D u r i n g I F C t h e r a p y t w o o u t o f p h a s e

    m e d i u m - f r e q u e n c y e l e c t r i c a l c u r r e n t s ( 2 - 4 K h ) a r e

    d e l i v e r e d a c r o s s t h e s u r f a c e o f th e s k i n . T h e s k i n

    o f f e r s l i t t l e r e s i s t a n c e t o e l e c t r i c a l c u r r e n t s a t t h i s

    f r e q u e n c y r a n g e a n d b y o v e r c o m i n g s k i n i m p e d a n c e

    t h e c u r r e n t i s a b l e t o p e n e t r a t e d e e p e r i n t o t h e t i s -

    s u e s . A t t h e p o i n t w h e r e t h e t w o c u r r e n t s c l a s h o r

    i n t e rf e r e a n e w ' i n t e r f e r e n c e ' w a v e i s p r o d u c e d . T h e

    r e s u l t a n t i n t e r f e r e n c e w a v e i s m o d u l a t e d i n i t s

    a m p l i t u d e a n d i t i s c l a i m e d t h a t t h i s a m p l i t u d e m o d -

    u l a t e d w a v e i s a b l e t o e x c i t e t is s u e l o c a t e d i n d e e p -

    s e a t e d s tr u c t u re s t o p r o d u c e a v a r i e t y o f p h y s i o l o g i c a l

    a n d e f f e c ts w h i c h c o n t r i b u t e t o t h e p r o p o s e d c l i n i c a l

    e f f e c t s o f t h i s m o d a l i t y ( s e e F i g . 1 ). I F C i s o n e o f

    t h e m o s t f r e q u e n t l y u s e d e l e c t r o t h e r a p i e s e m p l o y e d

    b y p h y s i o t h e r a p i s t s ( P o p e e t a l . 1 9 9 5 ). A r e c e n t s u r -

    v e y b y o u r s e l v e s h a s f o u n d t h a t p h y s i o t h e r a p i s t s u s e

    E l e c t r o t h e r a p y f o r p a in r e li e f: d o e s i t w o r k ? 1 5

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    Where currents 1 and 2 interfere N

    a 100Hz ampli tude modulated Sum matio nf

    .wave is forme d currents

    F i g . I T h e f o r m a t i o n o f a n i n te r f e re n c e c u r re n t w a v e . T w o

    o u t o f p h a se c u r r e n t s a ) a n d b ) a r e d e l i v e r e d a c ro s s t h e

    s u r f a c e o f t h e s k i n t o g e n e r a t e a n in t e r e f e r e n c e c u r r e n t c )

    w h i c h i s m o d u la t e d i n i ts a m p l i tu d e . C u r r e n t a ) a n d b ) a r e

    d e l i v e r e d i n t h e k i l o h e r t z r a n g e t o o v e r c o m e t h e r e s is t an c e o f

    t h e s k i n . I t i s c l a im e d t h a t t h e r e s u l t a n t a m p l i t u d e m o d u la t e d

    i n te r f e re n c e w a v e , w h i c h h a s a f re q u e n c y o f a p p r o x i m a t e l y

    1 0 0 H z , e x c i t e s d e e p - s e a t e d n e r v o u s t is s u e l e a d in g t o

    analgesia

    I F C t o r e l i e v e p ai n , r e d u c e s w e l l i n g , p r o m o t e h e a l i n g

    o f w o u n d s a n d b o n e f r a c t u r e s , a n d t o r e s t o r e f u n c -

    t i o n a s s o c i a t e d w i t h m u s c l e w e a k n e s s ( J o h n s o n

    T a b a s a m 1 9 9 8) .

    I t h as b e e n s u g g e s t ed t h at I F C m a y b e m o r e

    e f f e c t i v e t h a n T E N S f o r t h e t re a t m e n t o f p a i n s o f

    m u s c u l o s k e l e t a l o r v i s c e r a l o ri g i n . I F C m a y , t h e r e -

    f o r e , b e m o r e c l i n i c a l l y e f f e c t iv e t h a n T E N S f o r c e r -

    t a i n c o n d i t i o n s a n d , t h u s , i t m a y b e n e c e s s a r y t o

    i n d i c a t e I F C a n d T E N S f o r t h e tr e a t m e n t o f d i f f e r -

    e n t c l i n i c a l c o n d i t i o n s . T h i s t h e o r y , h o w e v e r , i s

    e n t i r e l y s p e c u l a t iv e a n d a t p r e s e n t h a s n o o b j e c t i v e

    e v i d e n c e i n i t s s u p p o r t .

    P r o b l e m s w i th I F C l i t e r a t u r e

    T h e l i t e r a tu r e o n I F C i s s p a r s e a n d t h e r e i s a l a c k o f

    o b j e c t i v e e v i d e n c e s u p p o r t i n g i t s c l a i m e d a n a l g e s i c

    e f f e c t i v e n e s s . P u b l i s h e d s t u d i e s o n I F C l a c k a d e -

    q u a t e c o n t r o l o r p l a c e b o g r o u p s , a n d t h i s d r a w s i n t o

    q u e s t i o n t h e r e l i a b i l i t y a n d v a l i d i t y o f t h e r e s u l ts

    a n d c o n c l u s i o n s .

    T h e p l a c e b o e f f e c t i s a p o w e r f u l p h e n o m e n o n

    w h i c h r e l i e v e s m a n y c o n d i t io n s i n c l u d i n g p a i n ( W a l l

    1 9 9 3 ) a n d t h e i m p o r t a n c e o f d e t e r m i n i n g w h e t h e r

    e l e c t r o t h e r a p i e s p r o d u c e e f f e c t s o v e r a n d a b o v e t h o s e

    o f p l a c e b o c a n n o t b e e m p h a s i z e d e n o u g h ( G e o r g i o u

    1 9 96 , M c Q u a y M o o r e 1 9 96 ). P l a c e b o i n t e r v en -

    t i o n s a r e u s e d i n r e s e a r c h t o e n a b l e i n v e s t i g a t o r s t o

    d i s c r i m i n a t e b e t w e e n t h e e f f e c t s o w i n g t o a n a c t i v e

    i n g r e d i e n t i n t h e t h e r a p e u t i c a g e n t a n d n o n - s p e c i f i c

    e f f e c t s w h i c h c a n r e s u l t f r o m m a n y f a c t o r s i n c l u d i n g

    t h e i n t e r a c t i o n b e t w e e n i n v e s t i g a t o r a n d s u b j e c t .

    P l a c e b o s h a v e n o k n o w n a c t i v e th e r a p e u t ic i n g r e d i -

    e n t a n d t h e y a r e u s e d t o i m i t a t e t h e t r e a t m e n t u n d e r

    s t u d y . I f t r e a t m e n t e f f e c t s a r e s h o w n t o b e n o g r e a t e r

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    6 C l i n i c a lEf fect iveness in Nu rsing

    than p lacebo , then i t i s importan t to ques t ion the

    phys io log ica l ra t iona le underp inn ing the c l in ica l use

    o f th e t r e a tm e n t . N e w d ru g s a re r e q u i re d to u n d e rg o

    thorough eva lua t ions in the labora to ry to p rove tha t

    th e d ru g p ro d u c e s e f f e c t s w h ic h a re g re a t e r t h a n

    th o s e p ro d u c e d b y a p l a c e b o d ru g (W a l l 1 9 93 ). T h i s

    i s a c h ie v e d b y p e r fo rm in g p la c e b o -c o n t ro l l e d s tu d ie s

    in th e l a b o ra to ry b e fo re th e t r e a tm e n t i s im p le m e n te d

    in the c l in ic . Th is , however , i s no t the case a t p resen t

    fo r e lec tro the rap ies , such as TENS and IFC. I t i s

    be l ieved tha t p lacebo e ffec ts a re o f ten g rea tes t fo r

    expens ive , and impress ive look ing the rap ies such as

    TENS and o the r e lec tro the rap ies (Evans 1985 , Wall

    1 9 9 4 ) . Mo d e m IF C s t im u la to r s l o o k t e c h n ic a l ly

    impress ive and requ ire ac t ive the rap is t invo lvement

    in the admin is t ra t ion o f the t rea tment . The p roduc t io n

    of an unfamil ia r t ing l ing sensa t ion a lso fu r the r

    enhances the p lace bo e ffec t a s soc ia ted with IFC s t im-

    u la to rs (Evans 1985 , Kien le & Kiene 1998) .

    T h e re i s a n e e d fo r m o re r ig o ro u s ly c o n t ro l l e d

    s tu d ie s w h ic h in c o rp o ra t e a p l a c e b o t r e a tm e n t g ro u p

    to a s s e s s th e t ru e t r e a tm e n t e f f e c t s o f IF C . T h i s w i l l

    a l lo w b o th th e ra p is t a n d p a t i e n t t o b e c o n f id e n t t h a t

    th e t r e a tm e n t i s p ro d u c in g i t s e f f e c t s o w in g to a n

    a c t iv e c o m p o n e n t o f t h e th e ra p y .

    T h e re a re m a n y e th i c a l c o n c e rn s r e g a rd in g th e

    admin is t ra t ion o f a p lacebo t rea tment to pa t ien ts su f-

    fe r ing from c l in ica l pa in . Th is makes i t d i f f icu l t to

    p e r fo rm c l in i c a l s tu d ie s w h ic h in c o rp o ra t e p l a c e b o

    contro l g ro ups tha t a re a im ed a t a s sess ing the c l in ica l

    e ffec t iveness o f a the rapy . However , in i t ia l ins igh ts

    in to the the rapeu t ic e ffec t iveness and p lacebo e ffec ts

    a s s o c ia t e d w i th a th e ra p y c a n c o m e f r o m l a b o ra to ry -

    based s tud ies on hea l thy ind iv idua ls .

    Laboratory s tudies

    T h e in i t i a l a s s e s sm e n t s o f a n y n e w a n a lg e s i c

    t r e a tm e n t c o n s i s t s o f t h o ro u g h e v a lu a t io n s in th e

    l a b o ra to ry o n h e a l th y in d iv id u a l s b e fo re t r i a l s a re

    c o n d u c te d o n p a t i e n t s i n th e c l in i c . L a b o ra to ry -

    b a s e d s tu d ie s a l lo w th e in v e s t ig a to r s :

    9 to c h e c k th e s a fe ty a n d e f f e c t iv en e s s o f t h e

    trea tment be fore c l in ica l t r ia ls

    9 to a s s e ss th e e f f ic a c y o f a t r e a tm e n t u n d e r

    s t r i ct ly c o n t ro l l e d c o n d i t io n s

    9 to c a re fu l ly c o n t ro l a n d m a n ip u la t e th e

    o u tc o m e m e a s u re s u n d e r s tu d y , su c h a s th e

    in t e n s i ty a n d th e lo c a t io n o f t h e p a in

    9 to c a re fu l ly c o n t ro l a n d m a n ip u la t e th e

    t r e a tm e n t p a ra m e te r s u n d e r in v e s t ig at io n .

    T h e re a re a v a r i e ty o f ex p e r im e n ta l p a in m o d e l s

    w h ic h h a v e b e e n u s e d b y w o rk e r s to in d u c e p a in in

    hea l thy sub jec ts in labora to ry s tud ies (e .g . e lec tr i -

    c a l , t h e rm a l , m e c h a n ic a l a n d c h e m ic a l ) . T h e c o ld -

    i n d u c e d p a i n t e c h n i qu e h a s b e e n e m p l o y e d f o r o v e r

    5 0 y e a r s to e v a lu a te th e a n a lg e s i c e f f e c ts o f d ru g s

    and e lec tro the rap ies in hea l thy sub jec ts and i t i s

    e s t a b l is h e d a s a s a fe m e th o d fo r t h e in d u c t io n o f a

    deep-sea ted , ach ing , pa in sensa t ion s imila r to tha t

    exper ienced b y pa t ien ts su ffe r ing c l in ica l pa in (W olff

    e t a l, 1966 , Posn er e t a l. 1985 , Grac e ly 1989, Grace ly

    1994) . The tech n ique invo lves the imm ers ion o f the

    d is ta l por t ion o f a l imb (usua l ly the hand) in to ve ry

    c o ld w a te r t o p ro d u c e a r a p id o n s e t o f p a in s e n s a tio n .

    A v a r i e ty o f o u tc o m e m e a s u re s c a n b e m o n i to re d

    during the co ld- induced pa in te s t inc lud ing the t ime-

    to -pa in th resho ld , and pa in to le rance and pa in ra tings

    such as pa in in tens i ty and unp leasan tness .

    S tu d ie s w h ic h h a v e e x a m in e d th e a n a lg e s i c

    e f fe c t s o f IF C o n e x p e r im e n ta l ly - in d u c e d p a in in

    h e a l th y s u b je c ts h a v e p ro d u c e d c o n f l i c t in g re s u lt s .

    S c o t t a n d P u rv e s (1 9 9 1 ) e x a m in e d th e e f fe c t s o f IF C

    o n i s c h a e m ic p a in in d u c e d b y th e to u rn iq u e t t es t o n

    1 5 h e a l th y v o lu n te e r s . T h e y fo u n d th a t a c t iv e IF C

    d id n o t e l e v a te t im e to to l e ra n c e o f i s c h a e m ic p a in

    w h e n c o m p a re d to a s h a m IF C s t im u la to r . In c o n -

    t r as t , p re l im in a ry w o rk u s in g th e c o ld - in d u c e d p a in

    t e c h n iq u e b y o u r g ro u p fo u n d th a t IF C c a n e l e v a te

    th e t im e to p a in th re s h o ld in h e a l th y v o lu n te e r s ,

    a l th o u g h a p l a c e b o c o n t ro l g ro u p w a s n o t e m p lo y e d

    (S te p h e n s o n & J o h n s o n 1 99 5 ).

    T h e fo l lo w in g l a b o ra to ry -b a s e d s tu d y w a s p e r -

    fo rm e d to in v e s t ig a te th e a n a lg e s i c e f f e c t s o f IF C

    u n d e r p l a c e b o -c o n t ro l l e d c o n d i t io n s u s in g a n e x p e r -

    im e n ta l p a in m o d e l .

    M E T H O D O L O G Y

    Subjects

    F o r ty e l e c t ro th e ra p y n a iv e , h e a l th y u n iv e r s i ty s u b -

    j e c t s w e re r e c ru i t e d f ro m n o t i c e -b o a rd a d v e r t i s e -

    m e n t s (2 9 f e m a le s , 1 1 m a le s ; a g e m e a n = 2 6 y e a r s ) .

    A l l s u b je c t s a t t e n d e d th e l a b o ra to ry fo r a b r i e f

    f a m i l i a r i z a t io n s e s s io n w i th in th e w e e k p re c e d in g

    th e e x p e r im e n t , d u r in g w h ic h th e y w e re g iv e n a

    v e rb a l a n d w r i t t e n e x p la n a t io n o f th e n a tu re o f

    th e e x p e r im e n t . A l l s u b je c t s w e re a l s o s c re en e d fo r

    c o n t ra in d ic a t io n s to e l e c t ro th e ra p y a s in d ic a t e d b y

    th e C h a r t e re d S o c ie ty o f P h y s io th e ra p y ( s t an d a rd s

    fo r th e u s e o f e l e c t ro p h y s ic a l m o d a l it i e s) . S k in w a s

    te s t e d fo r n o rm a l s e n s a t io n b y u s in g s t a n d a rd

    sharp /b lun t and ho t /co ld te s ts , and a l l sub jec ts

    a d m i t t e d o n to th e s tu d y c o m p le te d a c o n s e n t fo rm .

    A l l e x p e r im e n t s w e re a p p ro v e d b y th e L e e d s

    Me t ro p o l i t a n U n iv e r s i ty E th ic s C o m m i t t e e .

    E X P E R I M E N T L P R O C E D U R E

    The experim ents were cond uc ted by a female inves t i -

    ga to r (GT) us ing a s imila r me thodology to tha t

    employed in p rev ious s tud ies pe rfo rmed by the

    authors (Johnson et a l. 1989, Johnson et a l. 1992,

    S tephenson & Johnson 1995 , Tabason and Johnson

    1996, Tabasam & Johnson 1997). All subjects

    fo l low ed a se t o f wri t ten insmac t ions dur ing the exper-

    imenta l sess ion under the gu idan ce o f the inves t iga to r .

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    Electrotherapy for pain relief: does it work? 17

    T r e a t m e n t T r e a t m e n t

    S w i t c h o n h o f f

    C o ld in d u ced ~ C

    pain test

    I lOmin cyce

    C y c l e 1 C y c l e 2 C y c l e 3 C y c l e 4 C y c l e 5 C y c l e 6

    I I I I I I I

    min 1 rain 2 rain 3 rnin 4 rnin 5 min 6 rain

    m e~

    Fig. 2 Time course of the experimental procedure

    Subjects were randomly allocated, by pulling a

    number out of a hat, to one of the following treat-

    ment groups before the start of the experiment:

    9 active IFC

    9 sham IFC

    Each subjects completed 6 10 min cycles of the

    cold-induced pain test (two pre, two dur ing and two

    post treatment) (see Fig. 2). The outcome measures

    during each of the six experimental cycles of the

    cold-induced pain test were:

    9 the time to pain threshold

    9 and the self report of pain intensity and pain

    unpleasantness.

    P A IN I N D U C T I O N O N E C Y C L E O F

    T H E C O L D - I N D U C E D P A I N T E S T )

    During each cycle of the cold- induced pain test, the

    subjects non-domin ant hand was innnersed into a

    warm water bath (37~ for 5 min (Fig. 3). The hand

    was then transferred into (iced) cold water (0-2~

    until it became defin itely painfu l (e.g. 'the ve ry first

    sensation of pain in the han d') when the subject made

    the statement 'P ain!' . Time-to-pain threshold was

    recorded as the time from hand immersion in cold

    water to the very first sensation of pain. The hand

    remained immersed in the cold water for a further 30

    s after which it was removed . Pain intens ity and pain

    unpleasantness ratings were recorded as the intensity

    and unpleasantness of pain immediately prior to

    removal of the hand from the cold water and were

    recorded using a 10 cm visual analogue scale (where

    0= no p ain and 10= worst pain imaginable for pain

    intensity, 0= not unpleasant at all and 10= most

    unpleasant I could imagine for pain unpleasantness).

    If clarification on how to distinguish between

    pain intensity and pain unpleasantness was

    requested by the subjects they were told that inten-

    sity related to 'the severity of the pain in the hand'

    and unpleasantness to 'the way that you feel about

    the pain in the hand '. The cycle was completed by a

    rest period whereby the subject read a magazine.

    Prior to the start of the experiment, four self-

    adhesive electrodes (4 4 cm) were applied to all

    subjects in a quadripolar fashion on the anterior

    aspect of the subjects forearm 5 cm above the first

    wrist crease (Fig. 4). The purpose of these electrode

    HAND IN

    Warm HAND IN

    Water Ice Water

    at 37~

    I

    141 hi4

    I I

    I 5 Min i

    t t

    "PAIN"

    Pain

    Threshold

    HAND

    OUTPain Ratings

    30 sec i

    5 Min

    R e s t ~ I

    ~J

    i

    Pain ntensity cale

    0 10

    No Pain Worst Pain

    Imaghlable

    P a i n u n p l e a s a n t n e s s s c a l e

    0 10

    Not Most

    Unpleasant unpleasant I

    at all could magine

    Fig 3 One cycle cold induced pain

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    8 Clinica l Effectiveness in Nurs ing

    q

    ~Anterior aspect of the arm

    Nerve activity generated

    k ~ / ( travels toward the central

    nervous system

    II Channel 1 electrodes

    Channel 2 electrode s

    Fig

    4 The location of the electrodes used to deliver

    treatment. a) Electrode placement on anterio r aspect of the

    arm. b) The location of the resultant interference wave

    placements was to ta rge t the median nerves (deep

    affe rents emerging from the pa infu l , immersed

    hand) . Al thoug h the e lec t rodes were appl ied pr ior to

    the s ta r t of the exper imenta l procedure , the t rea t -

    ment w as only adm iniste red dur ing cyc les 3 and 4

    (e .g . the two during t rea tment cyc les) dur ing which

    a l l subjec ts rece ived 20 min of unin te rrupted t rea t -

    ment (e i ther ac t ive or sham IFC).

    T R E T M E N T

    G R O U P S

    A l l su b je c t s r e c e iv e d t r ea tme n t w h ic h w a s d e l iv e re d

    u s in g a n EMS M e d i -L in k c o n t ro l mo d u le Mo d e l 7 0

    a n d Me d i -L in k In t e r fe re n t i a l mo d u le mo d e l 7 1 . Th e

    current output f rom th is device was regula ted en

    route to the s ubjec t using an e lec t ronic c i rcui t which

    enabled the invest ig a tor to contro l whether or not

    the subjec ts rece ived a current output f rom the IFC

    device (e .g . rece ived e i ther ac t ive IFC or sham

    IFC), but i t d id not a l te r the output charac te r is t ics of

    IFC in any way. In addi t ion , the output f rom the IFC

    d e v ic e w a s d i sp l a y e d o n a c a th o d e r a y o sc i l l o sc o p e

    during the t rea tment cyc les for both the ac t ive and

    sham t rea tment groups.

    Act ive IFC

    A c t iv e IFC w a s sw i t c h e d o n a t th e e n d o f t h e se c o n d

    pre- t rea tment cyc le and the in tensi ty of s t imula t ion

    was adjusted by the subjec t to produce a ' s t rong

    but com fort able s timul ation' (mean~_+SD = 8.45+

    2.65 mA). Subjec ts were requested to mainta in th is

    in tensi ty leve l throughout the two t rea tment cyc les

    by making m inor ad justm ents to the in tensi ty d ia l of

    the IFC uni t . The e lec t r ica l charac te r is t ics of ac t ive

    IFC were chosen fo l lowin g examina t ion of the l ite r-

    a ture which indica ted tha t an ampl i tude modula ted

    f re q u e n c y o f 1 0 0 H z sh o u ld b e e mp lo y e d w h e n

    using IF C for the re l ie f of pa in (DeDom enico 1987,

    Niko lova 1987, Savage 1992, Low Reed 1994,

    Mart in 1994, Pope e t a l . 1995) . There i s , however ,

    a t present , no s t rong evidence to support the use of

    th is f requency. The ampl i tude modula ted wave was

    de l ivered using a cont inuous pa t te rn~ which was

    a c h ie v e d b y u s in g tw o s in u so id a l c a r r i e r w a v e s

    de l ivered a t 4000 cyc les per second and 4100 cyc le s

    per second (Fig. 1).

    S h a m I F C

    Sham IFC was used as the p lacebo contro l . Sham

    IFC w a s d e l iv e re d u s in g th e sa me IFC d e v ic e as

    used for the ac t ive IFC group except tha t the sub-

    jec ts rece iv ed no current output . The p lacebo e ffec t

    was re inforced by a verba l suggest ion f rom the

    invest iga tor tha t, 'The IF C uni t re l ieves pa in by sub-

    threshold s t imula t ion which you wi l l not be able to

    fe e l ' , a n d b y d i sp l a y in g th e o u tp u t f ro m th e IFC

    device on a ca thode ray osc i l loscope . No subjec ts in

    the present s tudy qu est ioned th is procedure .

    S T A T I S T I C A L A N A L Y S I S

    A pre- t rea tment base l ine mean was ca lcula ted for

    the two pre- t rea tment cyc les for each indiv idua l .

    Be tween subjec t var iance in pre - t rea tment base l ine

    va lues was la rge , as ev idenced by the SD va lues

    and, there fore , the percentage change in pa in thresh-

    old f rom the pre - t rea tment base l ine was used as a

    su mma ry me a su re o f r e sp o n se . Th e p e rc e n ta g e

    change in outcome measures dur ing and post t rea t -

    ment w as ca lcu la ted by subtrac t ing the pre - t rea t -

    ment mean from each of the dur ing and

    post - t rea tment observa t ions, and represent ing the

    va lue as a percentage change from the pre - t rea tment

    base l ine mean. A two-way ana lysis of var iance for

    re p e a t e d me a su re s (RM-A N O V A ) w a s p e r fo rme d

    on the percentage change for each of the outcome

    measures (Jande l Sc ient i f ic Gm bH 1994) .

    RE S ULTS

    The mear~+SD results for ice pain threshold, pain

    in tensi ty and unpleasantness ra t ing a re shown in

    Table 1. Pre-treatment baseline measures w ere similar

    in magni tude to previous work in th is and o ther labo-

    ratories using the s ame tech nique (Pos ner et al . 1985,

    Johnso n Wils on 1997, Tabason Johnson 1996).

    I CE P A I N T H R E S H O L D

    No signif icant d i f fe rences in pa in threshold where

    found be tween the two pre- t rea tment cyc les

    (mear~+SD diffe rence pre - t rea tmen t cyc le 1 and 2 =

    -0 .43s+ 4.5s, P=0.55 , p a i red t - test , n=40) . The mean

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    P ~

    t r e a t m e n t I

    E l e c t r o t h e r a p y f o r p a in re l ie f : d o e s i t w o rk? 9

    P e r D u r i n g D u r i n g P o s t P o s t

    t r e a t m e n t 2 t r e a t m e n t I t r e a t m e n t 2 t r e a t m e n t I t r e a t m e n t 2

    P a i n t h r e s h o l d s )

    a c t i ve 1 8 .1 + 1 2 .7 1 6 . 9 + 1 0 .6 2 1 . 8 + 1 3 .2 2 4 . 4 + 1 5 .2 2 1 . 0 + 1 7 .2 2 1 . 4 + 1 7 .8

    s h a m 1 8 .2 _ + 1 0 . 7 2 0 . 3 _+ 1 2 . 6 2 0 . 5 + 1 2 . 1 2 2 . 6_ + 1 2 . 6 2 0 . 7_ + 1 2 . 8 2 0 . 5_ + 1 2 . 2

    P a i n i n t e n s i t y c m s )

    ac t i ve 5 .8 _+ 2 .0 6 .0 _+ 1 .9 5 .6 + 2 . I 5 .8 + 1 .9 6 .2 + 2 .2 6 .3 + 2 .0

    sham 5.7 _+ 1 .9 5 .6 _+ 2 .2 5 .6 _+ 1 .8 5 .4 _+ 2 . I 6 . I + 2 .2 6 .3 _+ 2 .5

    P a i n u n p l e a s a n t n e s s c m s )

    ac t i ve 6 ,2 _+ 2 .0 6 .3 _+ 2 .0 5 .7 + 2 .2 6 .2 _+ 2 .2 6 .7 _+ 2 .4 6 .7 + 2 .2

    s h a m 6 . 5 + 2 , 3 6 . 2 _+ 2 . 6 6 . 0 _ + 2 . 7 5 . 6 + 2 . 6 6 . 3 _ + 2 . 6 6 . 2 + 3 . 0

    pre-treatment baseline was calculated for each ind i-

    vidual and no significant differences in this baselin e

    were found between the two treatment groups

    (mea~+SD IFC=17.5s+ll.6s, sham=19.2s+ll.4s,

    P=0.63, unpaired t-test, n=20 per group).

    There was rapid rise in the percentage change in

    pain threshold for the IFC group which occurred

    within 10 min of ]FC switch on (Fig. 5). This eleva-

    tion in pain threshold rapidly declined and had

    returned to 20 of the baseline value within 10 min

    of IFC switch off. The percentage change in pain

    threshold for the sham group mirrored that of the

    IFC group across the treatment cycles, although i t

    was significantly smaller in magnitude. This

    response profile for the sham IFC group is similar t o

    that observed for other placebo electrotherapyies

    administered in previous experiments by ourselves

    and others.

    These observations were con firmed in the statis-

    tical analysis. A two-way analysis of variance for

    repeated measures (RM-ANOVA) was performed

    on the percentage change in pain threshold from the

    pre-treatment baseline for the two during- and two

    post-treatment cycles. Significant effects were

    foun d for time (e.g. across the two during- and two

    post-treatment cycles: P0.05). The percentage change

    in pain ratings from the pre-treatment baseline for

    each of the during and post-treatment observations

    was calculated (Fig. 6 & 7). The results of the RM-

    ANOVA across the two during- and two post-treat-

    ment cycles are shown in Table 2.

    P a i n i n t e n s i t y r a t i n g

    There were no significant group effects for pain

    intensity ratings (Fig. 6, Table 2). S ignificant effects

    were found across the different levels of time

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    2 0 l in i c a l E f f e c t iv e n e s s i n N u r s i n g

    A c r o s s t w o d u r i n g a n d p o s t

    t r e a t m e n t c y c l e s

    A c r o s s tw o d u r i n g

    t r e a t m e n t c y c l e s

    D F F P D F F P

    P a in t h r e s h o ld

    t im e 3 5 . 4 0 . 0 0 2

    g r o u p I 3 . 4 0 . 0 7

    g r o u p x t im e i n t e r a c t i o n 3 1 .5 0 . 2

    Pain- intensity rat ing

    t im e 3 3 . 3 0 . 0 2

    g r o u p I 0 . 3 0 . 5 5

    g r o u p x t im e i n t e r a c t i o n 3 0 . 7 0 . 5 4

    Pain-unp leasantness ra t ing

    t im e 3 7 . 7 0 . 0 0 0 I

    g r o u p I 1 .8 0 . 2

    g r o u p x t im e i n t e r a c t i o n 3 3 . I 0 . 03

    8 . 2 0 . 0 0 7

    3 . 7 0 . 0 6

    0 . 3 3 0 . 5 7

    0.19 0.66

    0.49 0.5

    1.5 0.22

    O 18 0.68

    1.22 0.28

    10.2 0.003

    ~ 2 ~

    ~ ~

    20

    g ~ o

    o N s

    -10

    e ~

    D~g 1 Org 2 Post 1 Post 2 ~

    i 10 min

    20

    ain 10 min

    20

    min

    E x p e r i m e n t a l C y c l e

    F i g 6 Mean_+SE ercentage change in pa in in tens i t y ra t ing

    f r o m p r e - t r e a t m e n t b a s e li n e f o r sh a m - n - - ) a n d I FC - 0 - )

    g r o u p s

    D r g = d u r i n g t r e a t m e n t ; P o s t = p o s t t re a t m e n t

    ( e . g. t w o d u r i n g a n d t w o p o s t - t r e a t m e n t c y c l e s ) f o r

    t h e p e r c e n t a g e c h a n g e i n p a i n i n t e n s i t y r a t in g f r o m

    t h e p r e - t r e a t m e n t b a s e l in e . T h e r e w e r e n o s i g n i f i-

    c a n t e f fe c t s b e t w e e n t h e I F C a n d s h a m w h e n t h e d i f -

    f e r e n t l e v e l s o f t i m e w e r e t a k e n i n t o a c c o u n t ( t i m e x

    g r o u p i n t e r a c t i o n , T a b l e 2 ) . A n a d d i t i o n a l R M -

    A N O V A w a s p e r f o r m e d u s i n g o n l y d a ta f r o m t h e

    t w o d u r i n g - t r e a t m e n t c y c l e s . N o s i g n i f i c a n t e f f e ct s

    w e r e f o u n d ( T a b l e 2 ).

    P a i n U n p l e a s a n t n e s s r a t i n g

    S i g n i f i c a n t e ff e c t s w e r e f o u n d f o r t i m e ( e .g . t w o

    d u r i n g - a n d t w o p o s t - t r e a t m e n t c y c l e s ) a n d f o r t im e

    g r o u p i n t e r a c t i o n ( T a b l e 2 ) .

    A n a d d i ti o n a l R M - A N O V A w a s p e r f o r m e d

    u s i n g o n l y d a t a f r o m t h e t w o d u r i n g t r e a t m e n t

    c y c l e s . S i g n i f i c a n t e f f e c t s w e r e f o u n d f o r g r o u p x

    t i m e i n t e r a c t i o n ( P = 0 . 0 0 3 ) , b u t n o t f o r t i m e o r f o r

    g r o u p ( T a b l e 2 ) . S u b j e c t s i n t h e I F C g r o u p r a t e d

    p a i n t o b e m o r e u n p l e a s a n t d u r i n g t h e s e c o n d t r e a t -

    m e n t c y c l e , a l t h o u g h t h e m a g n i t u d e o f t h e t h is e l e -

    v a t i o n w a s s m a l l ( F i g . 7 ) . A d e c r e a s e i n p a i n

    F i g 7

    2 0 -

    1 5 -

    1 0 -

    5 .

    0 '

    5.

    - 10 . q \ \ / /

    -15 ~

    -20 i i ~ I

    ~ Drg 1 Drg 2 Post 1 Post 2

    ~ t0 min 20 ra in 10 ra in 20 ra in

    ~. E x p e r i m e n t a l C y c l e

    Plean+SE percen tage cha nge in pain unpleasantness

    f r o m p r e - t r e a t m e n t b a s e l in e f o r s h am - - n - - ) a n d I FC - Q - )

    g r o u p s

    D r g = d u r i n g t r e a t m e n t ; P o s t = p o s t t r e a t m e n t

    u n p l e a s a n t n e s s o c c u r r e d d u r i n g t r e a t m e n t i n t e r v e n -

    t i o n f o r t h e s h a m g r o u p , w h i c h r a p i d l y r e tu r n e d t o

    b a s e l i n e o n t r e a t m e n t t e r m i n a t i o n . T h is c h a n g e w a s

    n o t s t a t i s t i c a l l y s i g n i f i c a n t .

    S U M M A R Y O F T H E M A I N F I N D I N G S

    T h e m a i n f i n d i n g s o f t h is s t u d y w e r e t h a t :

    9 I F C e l e v a t e d p a i n t h r e s h o l d w h e n c o m p a r e d t o

    s h a m I F C d u r i n g t h e t w o t r e a t m e n t c y c l e s (e . g .

    w h e n t r e a t m e n t w a s s w i t c h e d o n ) b u t n o t p o s t

    t r e a t m e n t

    9 n o d i f f e re n c e s w e r e o b s e r v e d b e t w e e n t h e I F C

    a n d s h a m f o r t h e p e r c e n t a g e c h a n g e i n p a i n

    i n t e n s i ty a n d u n p l e a s a n t n e s s r a t i n g s

    9 a s i g n i f i c a n t i n c r e a s e i n p a i n i n t e n s i t y o c c u r r e d

    d u r i n g a n d a f t e r t h e t r e a t m e n t i n t e r v e n ti o n

    a l t h o u g h t h e r e w e r e n o s i g n i f i c a n t d i f fe r e n c e i n

    t h e m a g n i t u d e o f t h e s e c h a n g e s b e t w e e n t h e

    g r o u p s .

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    D I S U S S I O N

    T h i s s t u d y h a s s h o w n d i f f e r e n c e s in t h e a n a l g e s i c

    e f fe c ts o f I F C w h e n c o m p a r e d t o s h a m I F C o n c o l d -

    i n d u c e d p a i n i n h e a l t h y v o l u n t e e r s . A c t i v e I F C e l e -

    v a t e d p a in t h r e s h o ld w h e n c o m p a r e d t o s h a m I F C

    o n l y w h e n t h e s t i m u l a t o r w a s s w i t c h e d o n , a l t h o u g h

    t h i s e l e v a t i o n j u s t f a i l e d t o r e a c h s t a t is t i c a l s i g n i fi -

    c a n c e ( P = 0 . 0 6 ) . T h e e l e v a t i o n i n p a i n t h r e s h o l d

    r a p i d l y r e t u r n e d t o w a r d s t h e p r e - t r e a t m e n t b a s e l i n e

    v a l u e s w h e n t h e I F C s t i m u l a t o r w a s s w i t c h e d o f f ,

    s u g g e s t i n g th a t t h e r e w a s m i n i m a l p o s t I F C a n a l g e -

    s i a u n d e r t h e p r e s e n t e x p e r i m e n t a l c o n d i t i o n s .

    C h a n g e s i n p a i n i n t e n s i t y a n d p a i n u n p l e a s a n t n e s s

    r a t i n g s w e r e v a r i a b l e t h r o u g h o u t t h e e x p e r i m e n t a n d

    t h e r e w e r e n o s i g n i f ic a n t d i ff e r e n c e s i n th e m a g n i -

    t u d e o f t h e se r a t in g s b e t w e e n a c t i v e I F C a n d s h a m

    I F C . I t w a s , t h e r e f o r e , c o n c l u d e d t h a t I F C c a n e l e -

    v a t e e x p e r i m e n t a l p a i n t h r e s h o ld b u t h a d n o e f f e c t

    o n t h e p a i n r a t i n g s . T h e m a i n f i n d i n g s o f t h i s s t u d y

    w i l l b e d i s c u s s e d b e l o w .

    P a i n t h r e s h o l d

    T h i s s t u d y f o u n d t h a t I F C i n c r e a s e d i c e p a i n t h r e s h -

    o l d w h e n c o m p a r e d t o s h a m I F C , a l t h o u g h t h i s j u s t

    f a i l e d t o r e a c h s t a t i s t i c a l s i g n i f i c a n c e ( P = 0 .0 6 ) . T h i s

    f i n d i n g s u g g e s t s th a t I F C c a n m o d i f y t h e e x p e r i e n c e

    o f p a i n in h u m a n s o v e r a n d a b o v e t h a t p r o d u c e d b y

    p l a c e b o . A t p r e s e n t , t h e r e i s l i tt l e o b j e c t i v e e v i d e n c e

    t o s u p p o r t t h e a n a l g e s i c e ff e c t s o f I F C a n d s o m e

    c o m m e n t a t o r s h a v e , t h e r e f o r e, q u e s t i o n e d t h e e f f e c -

    t i v e n e s s o f t h e m o d a l i t y ( L o w R e e d 1 9 9 4 , M a r t i n

    1 9 9 4 ) . M o r e o v e r , t h e r e i s c o n f u s i o n o n t h e m o s t

    a p p r o p r i a t e w a y o f a d m i n i s t e r i n g I F C . S p e c i f i c

    t e x t b o o k s o n I F C o f f e r p r e s c r i p t i v e t r e a t m e n t

    r e g i m e s i n c o r p o r a t i n g s p e c i f i c e l e c t r i c a l c h a r a c te r -

    i s ti c s o f c u r r e n t d e l i v e r y f o r d i f f e re n t m e d i c a l c o n -

    d i t io n s ( D e D o m e n i c o 1 9 87 ; N i k o l o v a 1 9 8 7 ; S a v a g e

    1 9 9 2) . H o w e v e r , p h y s i o t h e r a p i s t s c o n t in u e t o

    a d m i n i s t e r t h e m o d a l i t y o n a t r i a l a n d e r r o r b a s is i n

    c l i n i c a l p r a c t ic e . A r e c e n t q u e s t i o n n a i r e s u r v e y p e r -

    f o r m e d b y o u r t e a m f o u n d t h a t p h y s i o t h e r a p i s t s

    r e p o r t e d t h at t h e y a d m i n i s t e r e d I F C f o r 1 1 - 2 0 m i n

    ( 2 7 : 3 5 ) d u r i n g e a c h t r e a t m e n t s e s s i o n a n d t h a t , o n

    a v e r a g e , e a c h p a ti e n t r e c e i v e d a c o u r s e o f 1 - 5 I F C

    t r e a t m e n t s e s s i o n s ( J o h n s o n T a b a s a m 1 9 9 8 ) . I t

    w a s n o t p o s s i b l e to d e t e r m i n e w h e t h e r t h e r a p i s t s

    e x p e c t e d t h a t t h e 1 1 - 2 0 m i n I F C t r e a t m e n t w o u l d

    p r o v i d e l o n g - l a s t i n g p a i n r e l i e f w h i c h o u t l a s ts s t i m -

    u l a t i o n . T h e p r e s e n t s t u d y h a s f o u n d t h a t I F C p r o -

    d u c e d a n i n c r e a s e i n p a i n t h r e sh o l d w h i c h w a s r a p i d

    i n o n s e t a n d o f f s e t , a n d o n l y o c c u r r e d w h e n t h e

    s t i m u l a t o r w a s s w i t c h e d o n . A s p o s t - s t i m u l a t i o n

    e f f e ct s w e r e m i n i m a l i t i s s u g g e s t e d t h a t t h e r e w i l l

    b e l i m i t e d a n a l g e s i c b e n e f it o n c e t h e s t i m u l a t o r i s

    s w i t c h e d o f f . T h e r e f o r e , i t i s p o s s i b l e t h a t p a t i e n t s

    w h o a r e m a n a g e d u s i n g I F C s t i m u l a t i o n l a s t i n g

    1 1 - 2 0 r a i n a r e re c e i v i n g n o b e n e f i t f r o m I F C w h e n

    t h e y l e a v e t h e c l i n i c . I F C m a y b e m o r e e f f e c t i v e l y

    e m p l o y e d t o r e l i e v e p a i n i f p a ti e n t s w e r e a l l o w e d t o

    Elec t ro therap y for pa in re l ie f i does i t work? 2

    s e l f - a d m i n i s t e r I F C a s a n d w h e n r e q u i r e d a t h o m e

    ( i n a s i m i l a r m a n n e r t o T E N S ) . T h i s w o u l d i n c r e a s e

    t h e t r e a tm e n t t i m e a n d , s u b s e q u e n t l y , t h e a m o u n t o f

    p a i n r e l i e f o b t a i n e d b y t h e p a t i e n t . K e y t e x t s o n t h e

    c l i n i c a l u s e o f I F C s u g g e s t t h a t I F C s h o u l d b e d e l i v -

    e r e d f o r n o m o r e t h a n 3 0 r a i n a t a t im e a n d t h e p r a c -

    t i c e o f d e l i v e r i n g I F C f o r s h o r t p e r i o d s o f t i m e

    m e r i t s f u r t h e r c o m m e n t a s i t h i g h l i g h t s t h e d a n g e r

    o f n o n - e v i d e n c e - b a s e d p r a c t i c e i n p h y s i o t h e r a p y .

    T h e r e i s c u r r e n t l y n o o b j e c t i v e e v i d e n c e t o s u p p o r t

    t h e u s e o f I F C f o r a s h o r t p e r i o d o f t i m e ( u n d e r 3 0

    r a i n ) , a l th o u g h i t h a s b e e n s u g g e s t e d t h a t c o n t i n u o u s

    I F C s t i m u l a t i o n m a y f a t i g u e p a t i e n t s ( D e D o m e n i c o

    1 9 8 7, N i k o l o v a 1 9 8 7 , S a v a g e 1 9 9 2 ). H o w e v e r , c l i n -

    i c a l st u d i e s o n T E N S h a v e s h o w n t h a t p a t i e n t s w h o

    d e l i v e r T E N S c a n u s e T E N S f o r m a n y h o u r s w i t h -

    o u t a n y o b s e r v a b l e f a t i g u e ( J o h n s o n e t a l . 1 9 9 1 ).

    T h e f i n d i n g s o f s t u d ie s o n c o n v e n t i o n a l T E N S h a v e

    a l s o s h o w n t h a t a n a l g e s i a o c c u r s d u r i n g r a t h e r t h a n

    a f t e r t r e a t m e n t ( J o h n s o n e t a l . 1 9 9 1 ) . P a t i e n t s w h o

    s e l f a d m i n i s t e r T E N S f o r c h r o n i c p a i n d e l i v e r

    T E N S t h r o u g h o u t t h e d a y , a s t h e y f i n d t h a t t h e

    g r e a t e s t a n a l g e s i a o c c u r s w h e n t h e T E N S d e v i c e i s

    s w i t c h e d o n ( J o h n s o n e t a l . 1 9 9 1 ) . T h e f i n d i n g s o f

    t h e p r e s e n t s t u d y s u g g e s t s I F C a n a l g e s i a m a y h a v e a

    s i m i l a r re s p o n s e p r o f i l e t o t h a t o f T E N S a n d , t h e r e -

    f o r e , g r e a t e r th e r a p e u t i c b e n e f i t f r o m t h i s m o d a l i t y

    m a y b e g a i n e d b y a d m i n i s t e r i n g i t i n a s i m i l a r

    m a n n e r t o T E N S .

    I t is i m p o r t a n t t o c o n s i d e r t h a t t h e I F C t r e a t m e n t

    p r o t o c o ls e m p l o y e d b y p h y s i o t h er a p i s ts m a y h a v e

    b e e n d e v e l o p e d t o s u i t t h e t h e r a p i s t ra t h e r t h a n t h e

    n e e d s o f t h e p a t i e n t. T h e m a j o r i t y o f I F C d e v i c e s i n

    u s e a r e l a r g e , n o n - p o r t a b l e a n d e x p e n s i v e , a n d a r e

    l o c a t e d i n h o s p i t a l d e p a r t m c n t s o r t h e r a p i s t s c l i n i c s .

    P a t i e n t s , t h e r e f o r e , n e e d t o a t t e n d t h e c l i n i c t o

    o b t a i n t r e a t m e n t . T h e r a p i s t s m a y b e u n a b l e t o

    a d m i n i s t e r I F C f o r m o r e t h a n 2 0 m i n , a s t h e i r c l i n i-

    c a l r o t a d i c t a t e s a t i m e - l i m i t e d c o n s u l t a t i o n . A s e r i e s

    o f s u b s e q u e n t t r e a t m e n t s e s s i o n s m a y b e i n d i c a t e d

    t o o v e r c o m e t h i s p r o b l e m , h o w e v e r , t h i s d o e s n o t

    p r o v i d e a d e q u a t e p a i n r e l i e f f o r t h e p a t i e n t .

    A n e c d o t a l r e p o r t s s u g g e s t t h a t 1 F C a n a l g e s i a i s

    c u m u l a t i v e w i t h s u c c e s s i v e t r e a t m e n t s e s s i o n s :

    H o w e v e r , i t i s l i k e l y t h a t o t h e r f a c t o r s , s u c h a s n a t -

    u r a l f l u c t u a ti o n s i n t h e h e a l i n g o f t h e c o n d i t i o n , m a y

    a c c o u n t f o r t h e o b s e r v a t i o n s . A t p r e s e n t , t h e r e i s

    i n s u f f i c i e n t e v i d e n c e t o s u p p o r t c l a i m s t h a t a s e r ie s

    o f I F C t r e a t m e n t s w i l l p r o d u c e c u m u l a t i v e e f f e c ts .

    I f I F C a n a l g e s i a i s s i m i l a r i n n a t u r e t o e l e c t r o t h e r -

    a p y ' s , s uc h a s T E N S t h e n p a t i e n t s s h o u l d b e a l l o w e d

    t o u s e t h e m o d a l i t y w h e n n e e d e d ( e . g . w h e n t h e y a r e

    i n p a i n ) . T h e d e v e l o p m e n t o f c h e a p e r p o r t a b l e I F C

    d e v i c e s m a y a l l o w c l i n i c s t o l o a n I F C d e v i c e s t o

    p a t i e n t s w h o w i l l b e a b l e t o s e l f - a d m i n i s t e l t r e a t m e n t

    a s a n d w h e n i t i s r e q u i r e d . T h i s a p p r o a c h h a s b e e n

    e m p l o y e d b y m a n y P a i n C l i n i c s s u c c e s sf u l l y f o r t h e

    m a n a g e m e n t o f p a i n b y T E N S . H o w e v e r , i t m a y b e

    m o r e a p p r o p r i a t e to i n v e s t in T E N S r a t h e r t ha n I F C ,

    a s T E N S i s c h e a p e r a n d e a s i e r f o r b o t h t h e t h e r a p i s t

    a n d t h e p a t i e n t t o a d m i n i s t e r . T h e r e a r e h y p o t h e t i c a l

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    9/11

    l in i c a l E f fe c t i v e n e s s i n N u r s i n g

    d i f f ere n c e s in th e m e c h a n i s m o f a c t io n o f IF C a g a in s t

    T E N S , a l th o u g h e v id e n c e w h ic h h a s e x a m in e d th e

    ana lges ic e ffec ts and c l in ica l e ffec t iveness o f the two

    m o d a l i t i e s i s n o t a v a i l a b le a t p re s e n t (D e D o m e n ic o

    1 9 8 7 , L o w R e e d 1 9 94 ). A p re l im in a ry b u t a s y e t

    u n p u b l i s h e d s tu d y b y o u r g ro u p h a s fo u n d th a t ,

    a l th o u g h IF C a n d T E N S s ig n i fi c a n t ly in c re as e p a in

    th resho ld to exper imenta l pa in , the re a re no d iffe r-

    e n c e s in th e m a g n i tu d e o f t h i s r e sp o n s e b e tw e e n

    TENS and IFC (Tabasam e t a l . 1998) . Furthe r work

    in th is a rea shou ld compare the ana lges ic e ffec ts ,

    m e c h a n i s m o f a c t io n a n d c l in i c a l e f f e c t iv e n e s s o f

    T E N S a n d IF C . T h i s i n fo rm a t io n w i l l h e lp th era p i st s

    to d e te rm in e th e ci r c u m s ta n c e s w h e re T E N S a n d IF C

    should be indicated separately.

    P a i n i n t e n s i t y a n d p a i n u n p l e a s a n tn e s s

    r a t i n g

    T h is s tu d y fo u n d n o d i f f e re n c e s b e tw e e n IF C a n d

    s h a m fo r th e p e rc e n ta g e c h a n g e in p a in in t e n s i ty

    and unp leasan tness ra t ings , and th is sugges ts tha t

    IF C d id n o t m o d i fy th e s e l f re p o r t o f p a in u n d e r th e

    p re s e n t e x p e r im e n ta l c o n d i t io n s . T h i s f in d in g i s

    c o n s i s t e n t w i th o u r p re v io u s s tu d ies o n T E N S u s in g

    th e s a m e t e c h n iq u e s ( J o h n s o n e t a l. 1 9 9 2 ). D e s p i t e

    th e l a c k o f d i f f e re n c e s b e tw e e n th e t r e a tm e n t

    g ro u p s , t h e re w a s a s ig n i f i c a n t i n c re a s e in p a in

    in t e n s i ty fo r b o th IF C a n d s h a m g ro u p s w h e n th e

    t r e a tm e n t in t e rv e n t io n w a s t e rm in a te d . T h i s

    in c re a s e in p a in in t e n s i ty r a t in g m a y b e a t t r ib u ted to

    a pos t- t rea tment inc rease in pa in in tens i ty , a l though

    th e m a g n i tu d e o f t h is r e b o u n d e f fe c t fo r IF C m a y b e

    n o g re a t e r t h a n th a t o f s h a m . S im i l a r r e b o u n d

    e f fe c t s h a v e b e e n o b s e rv e d in th e c l in i c w h e n

    p a t i e n t s r e p o r t t h a t p a in in t e n s i ty in c re a s e s w h e n

    T E N S i s s w i t c h e d o f f a n d th e ra p is t s s o m e t im e s u s e

    th i s t o c o n v in c e p a t ie n t s t h a t T E N S i s r e d u c in g th e

    m a g n i tu d e o f p a in. T h e a u th o r s w i s h to r e m a in c a u -

    t io u s a b o u t t h e s e f in d in g s a s th e y h a v e n o t b e e n

    re p ro d u c ib le in o u r p re v io u s s tu d ie s u s in g a c t iv e

    a n d s h a m e le c t ro th e ra p e u t i c in t e rv e n t io n s .

    T h e f in d in g s o f th i s s tu d y a re in a g re e m e n t w i th

    a p re v io u s s tu d y o n c o ld - in d u c e d p a in b y

    S te p h e n s o n a n d J o h n s o n (1 9 9 5 ) . T h i s s tu d y , h o w -

    e v e r , f a i le d to in c lu d e a p l a c e b o c o n t ro l , a n d i t w a s

    no t poss ib le to a t t r ibu te the e ffec ts on pa in th resho ld

    o b s e rv e d s o le ly to t r e a tm e n t w i th IF C .

    T h e f in d in g s o f t h i s s tu d y d i s a g re e w i th p re v io u s

    s tu d ie s b y S c o t t a n d P u rv e s (1 9 9 1 ) a n d T a y lo r e t al .

    (1 9 8 7 ) . S c o t t a n d P u rv e s (1 9 9 1 ) in v e s t ig a t e d th e

    a n a lg e s i c e f f e c ts o f IF C u s in g e x p e r im e n ta l p a in

    a n d , a l th o u g h th e i r s tu d y w a s p l a c e b o c o n t ro l l e d ,

    th e s e in v e s t ig a to r s e m p lo y e d a d i f f e re n t e x p e r im e n -

    t a l p a in m o d e l t o th e o n e e m p lo y e d b y o u r s e lv e s

    ( i s c h a e m ic p a in t e s t ) . T h i s m a y h a v e a c c o u n te d fo r

    th e d i f f e re n c e s o b s e rv e d b e tw e e n th e tw o s tu d ie s .

    T h e f in d in g s o f o u r s tu d y a l s o d i s ag re e w i th c l in i c a l

    s tu d ie s b y T a y lo r e t a l. (1 9 8 7 ) w h o in v e s t ig a t e d th e

    a n a lg e s i c e f f e c t s o f IF C o n r e c u r re n t j a w p a in .

    A g a in , a l th o u g h th e s tu d y w a s p l a c e b o c o n t ro l l e d , it

    w a s a c l in i c a l s tu d y p e r fo rm e d o n p a t i e n ts s u f fe r in g

    f ro m c l in i c a l p a in . I t i s im p o r t a n t t o a c k n o w le d g e

    th e p re s e n c e o f a d d i t io n a l p s y c h o s o c ia l a n d b e h a v -

    io u ra l f a c to r s w h ic h w o u ld m a rk e d ly in f lu e n c e th e

    re s p o n s e o f p a t i e n t s i n th e c l in i c . T h i s m a y h a v e

    a c c o u n te d fo r t h e d i f f e re n c e s o b s e rv e d b e tw e e n

    these two s tud ies .

    O N L U S I O N

    In c o n c lu s io n , t h i s s tu d y h a s s h o w n th a t IF C c a n e l e -

    va te exper imenta l pa in th resho ld , bu t had no e ffec ts

    o n p a in r a t in g s ; h o w e v e r , o n e s h o u ld b e c a u t io u s

    w h e n e x t r a p o la tin g th e f in d in g s o f l a b o ra to ry -b a s ed

    s tud ies us ing hea l thy sub jec ts to pa t ien ts su ffe r ing

    c l in ica l pa in . Neverthe less , th is s tudy h igh l igh ts the

    im p o r t a n c e in p ro v id in g e x p e r im e n ta l e v id e n c e f ro m

    both bas ic sc iences and c l in ica l p rac t ice to support

    the t rea tment approaches by c l in ic ians . Th is is e spe-

    c i a l ly a p p ro p r i a t e to n u r s in g w h e re p ra c t i c e c a n

    s t e m f ro m t r e a tm e n t p re fe ren c e s w h ic h a re b a se d o n

    a n e c d o ta l e v id e n c e .

    l i n i c a l i m p l i c a t i o n s a n d f u t u r e

    d i r e c t i o n s f o r r e s e a r c h

    T h e c l in i c a l im p l i c a t io n s fo r t h i s r e s e a rc h a re th a t

    IF C m a y b e u s e fu l c l in i c a l ly fo r p a in r e l i e f a s t h i s

    s tu d y h a s s h o w n th a t it c a n e l e v a te p a in th re s h o ld in

    h e a l th y v o lu n te e r s . In a n e a r l ie r s tu d y b y o u r s e lv e s

    ( J o h n s o n T a b a s a m 1 9 9 8 ) i t w a s s h o w n th a t IF C i s

    a d m in i s t e re d b y th e ra pi s t s 3 x 2 0 m in t r e a tm e n t s

    p e r w e e k in th e c l in i c , h o w e v e r , i t m a y b e m o re

    a p p ro p r i a t e to im p le m e n t a l o n g e r t r e a tm e n t t im e a s

    th i s s tu d y h a s in d ic a t e d m in im a l p o s t - t r e a tm e n t

    a n a lg e s i a . T h i s s tu d y h a s s h o w n th a t l a b o ra to ry -

    based s tud ies a re va luab le in the in i t ia l eva lua t ion o f

    the ana lges ic e ffec ts o f an e lec tro the rapy .

    O v e r a ll s u m m a r y

    T h is p a p e r h a s h ig h l ig h te d th e im p o r t a n c e o f l a b o -

    ra to ry -b a s e d s tu d ie s w h ic h s h o u ld b e e x te n d e d in to

    c l in ic a l r a n d o m iz e d -c o n t ro l l e d t r ia l s t o c o n f i rm th e

    c l in i ca l e f f e c t iv e n e s s o f IF C fo r t h e m a n a g e m e n t o f

    pa in . At p resen t , the re is l i t t le ob jec t ive ev idence in

    s u p p o r t o f IF C . T h e re i s a l s o a n e e d to c o m p a re th e

    e f fe c t s o f IF C w i th o th e r c h e a p e r , m o re e f f i c i e n t

    e l e c t ro th e ra p ie s, s u c h a s T E N S , w h ic h m a y h a v e

    c o s t e f f e c t iv e n e s s im p l i c a t io n s fo r t h e N H S a n d

    m a y a l s o in d ic a te th e a d m in i s t ra t io n o f IF C a n d

    T E N S fo r d i f f e re n t c l in ic a l c o n d i t io n s . I t i s c ru c ia l

    tha t c l in ic ians , e spec ia l ly when cons ide r ing t rea t-

    m e n t r e g im e s fo r p a t i e n t s , i n t e g ra t e k n o w le d g e

    g a in e d th ro u g h th e i r c l in ic a l e x p e r i e n c e w i th o b je c -

    t iv e e v id e n c e f r o m th e a v a i l a b le l i t e r atu re in o rd e r

    to a d v a n c e e x i s t in g c l in i c a l p ra c t i c e . T h e im p o r -

    t a n c e o f r e in fo rc in g th e im p le m e n ta t io n o f g o o d

    e v id e n c e -b a s e d p ra c t i c e b y h e a l th c a re p ro fe s s io n -

    a l s c a n n o t b e o v e r e m p h a s iz e d .

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    10/11

    C K N O W L E D G E M E N T S

    T h i s w o r k i s f u n d e d b y a n N H S E x e c u t i v e P h D s t u d e n t s h i p

    g r a n t n o . R A C 7 3 3 .

    RE FERENCE S

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    I r el a n d . P h y s i o th e r a p y 7 7 : 1 7 1 - 1 7 8

    C a r r o l l D , M o o r e A , T r a m e r M , M c Q u a y H 1 9 97

    T r a nsc n t a ne ou s e l e c t ri c a l ne r ve s t imu l a t i on doe s no t

    r e l i e ve in l a bour pa i n : up da t e d sy s t e ma t i c r e v i e w .

    C o n t e m p o r a r y R e v i e w s i n O b s t e t r ic s a n d G y n e c o l o g y ,

    S e p t e m b e r 1 9 97 1 9 5 - 2 0 5

    C a r r o ll D , T r a m e r M , M c Q u a y H , N y e B , M o o r e A 1 9 9 6

    R a n d o m i z a t io n i s i m p o r t a n t in s t u d ie s w i t h p a i n

    ou t c om e s : sys t e ma t i c r e v i e w o f t r a nsc u t a ne ous e l e c t r i c a l

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