International Journal of Biomedical And Advance Research

ISSN: 2229-3809 (Online) Journal DOI:10.7439/ijbar OD!N:IJ"#"N

Research Article
The effect of Acu-TENS on FEV1, six minute walk distance and dyspnoea in patients with chronic o structi!e pulmonary disease" a randomised trial
B.Vyas*1, S. Shah2, H. Tiwari3 and A. Singh4
1

Assistant Professor, Pharmacology, AMC-MET Medical College, LG hospital, Maninagar, Ahmedabad-3 !!! " #ndia Lect%rer, &'' Physiotherapy College, Ahmedabad, #ndia 3 &tatistician, ()L M%nicipal Medical College, Ahmedabad, india * Professor, Pharmacology, AMC-MET Medical College, LG hospital, Maninagar, Ahmedabad-3 !!! " #ndia
$

*Correspondence Info:
Dr. B. Vyas, Assistant Professor, Department of Pharmaco ogy, A!"#!$T !edica "o ege. Ahmeda%ad#3&'''& ()*arat. +ndia. E-mail# dr%m,yas-yahoo.com

A stract
Aim6 To see the effect of Ac)#T$7S on 8$V1, si2 min)te wa 9 distance and dyspnoea in patients of "/PD. !ethod6 8ifty fi,e patients with a mean age of :&years s)ffering from chronic o%str)cti,e p) monary disease with no pre,io)s e2pos)re of T$7S or ac)p)nct)re were se ected. The e2perimenta gro)p recei,ed 43 min)tes of Ac)#T$7S o,er ac)point %i atera y whi e the contro gro)p recei,ed p ace%o#T$7S with identica e ectrode p acement %)t no o)tp)t despite a f ashing ight indicating stim) )s de i,ery. ;)ng f)nction was meas)red as 8$V1 and 8V", si2 min)te wa 9 distance was meas)red )sing :!<T, whi e dyspnoea was meas)red )sing a shortness of %reath 1''#mm ,is)a ana og)e sca e. Result6 After 43 min)tes of Ac)#T$7S, the e2perimenta gro)p had increased 8$V1 %y 4.3=> .?3> "+ 2.=1 to :.'40 and 8V" %y on y '.:3 > .?3> "+ #'.4' to 1.=10. Si2 min)te wa 9 distance increased %y 14.32 metres .?3> "+ 1'.:= to 1=.??0 more in the e2perimenta gro)p. Dyspnoea decreased %y 1.2? mm .?3> "+#3.'' to '.410 more than the contro gro)p. Conclusion6 Ac)# T$7S may %e a )sef) non#in,asi,e a ternati,e in the management of dyspnoea in patients with chronic o%str)cti,e p) monary disease. This st)dy showed the effect of ong#term Ac)#T$7S. A sing e session of Ac)# T$7S increases 8$V1, :!<T and red)ces dyspnoea in patients with chronic o%str)cti,e p) monary disease. "ey#ords: Ac)p)nct)re points, T$7S, "hronic o%str)cti,e p) monary disease, 8orced e2piratory ,o )me, 8orced ,ita capacity, : !in)te wa 9 test, Dyspnoea

1. Introduction
"hronic o%str)cti,e p) monary disease ."/PD0 is a chronic progressi,e condition characterised %y airf ow resistance which is not f) y re,ersi% e )ng f)nction 1. Dsypnoea, e2cessi,e sp)t)m prod)ction, co)gh are the most common c inica feat)res. +t is estimated that three mi ion peop e died d)e to "/PD in 2''3, it4s going to %e third eading ca)se of death wor d wide %y 2'3'2. Ha f a mi ion peop e die e,ery year d)e to "/PD in +ndia, which is o,er 4 times the n)m%er of peop e who die d)e to "/PD in 5SA and $)rope 3 "/PD can %e managed %y pharmacotherapy for re ief of symptoms, reha%i itation programs and e2ercise to impro,e e2ercise to erance 4. D)e to e2pensi,e medications and dr)g4s ad,erse effects, a ternati,e approaches for the management of patients with "/PD needs to %e e2p ored.

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App ication of transc)taneo)s e ectrica ner,e stim) ation .T$7S0, a non in,asi,e moda ity o,er specific ac)points .A"5#T$7S0 has %een reported as an a ternati,e mode of management for %reath essness in "/PD patients 3. A re,iew of 1: randomised contro ed tria s, in,o ,ing 2?3= participants conc )ded that ac)p)nct)re is a safe and potentia y effecti,e inter,ention for patients with asthma and "/PD:. Ac)#Tens is %e ie,ed to e icit simi ar responses to man)a ac)p)nct)re in pain re ief =,&,?. The effect of Ac)#T$7S on dyspnoea has %een reported in some pop) ation 3.Administration of Ac)#T$7S can %e done %y patient himse f or the care gi,ers. +t may he p to contro dyspnoea and their %y promote @)a ity of ife in patients with "/PD, if pro,en to %e effecti,e. Hence, the research @)estion for this st)dy of patients with "/PD is A Bwhat is the effect of Ac)#T$7S on )ng f)nctions, : !in)te <a 9 distance .:!<D0 and dyspnoeaC.

$. !ethod
$.1 %esi&n A randomised, p ace%o contro ed, pre#test and post test design was carried o)t. $.$ 'articipants Am%) atory s)%*ects with a medica diagnosis of "/PD were referred %y medicine department of a m)nicipa hospita . Inclusion criteria D Diagnosis of stage 1 or 2 "/PD according to the (/;D c assification1' D <i ing to participate D A%i ity to comm)nicate and fo ow commands D +ndependent in mo%i ity E(clusion criteria D "o#e2isting +HD, D! or ne)ro ogica deficit D S)%*ects with cardiac pacema9er D Sensory deficit D Poor perception andEor cogniti,e f)nction D $pisode of ac)te e2acer%ation of o%str)cti,e airway disease within one month prior to data co ection D Treated with %ronchodi ator within si2 ho)rs prior to data co ection D $ar ier e2pos)re to T$7S or ac)p)nct)re $.) Ethics St)dy was appro,ed %y the A!" !$T $thics "ommittee of ;( Hospita F A!" !$T !edica "o ege. Ahmeda%ad. Participants were f) y informed of the st)dy protoco and signed a consent form prior to participation. $.* 'rocedure Demographic data s)ch age, gender, B!+, smo9ing history and medications were recorded. S)%*ect randomisation was done. $ igi% e participant were random y assigned to either e2perimenta .Ac)#T$7S0 or contro .p ace%o T$7S0 gro)p. ;)ng f)nctions, :!<D and dyspnoea were meas)red after the participant rested for 3' min)tes. A participants then recei,ed 43 min of either Ac)#T$7S or p ace%o T$7S. Participants were % ind to gro)p a ocation. Participants in contro gro)p were e2p ained that the stim) ation fre@)ency was not percei,a% e %y h)mans. /ne in,estigator was responsi% e for the app ication of %oth inter,entions. Then )ng f)nctions, :!<D and dyspnoea were meas)red again.

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Vyas et al +a le 1 'articipants Classification Accordin& +o Baseline Characteristics In Both ,roups VARIAB-E A($ G3' years '3 '3 3'#:' years 11 12 H:' years 12 1' ($7D$I !A;$ 2' 21 8$!A;$ & ': S!/J+7( $K#S!/J$I 1' 1' S!/J$I 13 1' 7/7#S!/J$I '3 '= B!+ 57D$I#<T '& '? 7/I!A; 11 '& /V$I#<T '? 1' +a le $ Baseline 0utcome !easures - mean 12%3 of oth &roups 04+C0!E !EA24RE 8$V1 > PI$D 8V" > PI$D :!<D .mt0 DLSP7/$A .mm0 $.5 Inter6ention E.'ERI!E/+A=2.=? .&.'20 ='.4: .3.310 324.1' .3:.110 3:.34 .=.?:0 C0/+R0=3.2: .&.110 ='.13 .4.4=0 323.3' .3=.4?0 3:.?::.=30 E.'ERI!E/+AC0/+R0-

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A written informed consent was o%tained from a the participants who f) fi ed the inc )sion criteria. The e2perimenta gro)p recei,e 43 min of Ac)#T$7S at %i atera ac)points $2#B1 11.These points are 9nown as Ding "h)an in Traditiona "hinese !edicine. They are ocated at '.3 Mc)n4 atera to the spino)s process of " = ,erte%ra, were 1 Mc)n4 is the distance %etween the media creases of the interpha angea *oints on an indi,id)a 4s midd e finger 3. $ach ac)point was c eaned with an a coho swa% to red)ce the resistance for passage of c)rrent. A non cond)cti,e 323 cm 2 p astic fi m was p)nct)red in the midd e creating a pore of diameter.'& cm. This fi m was p aced o,er the participant4s s9in, with the pore direct y o,er the mar9ed ac)point. A 323 cm 2 e ectrode was then p aced o,er each p astic fi m. This config)ration restricts e ectrica stim) ation to the ac)point on y. 2timulation5: 8re@)ency A 4 HNO P) se <idth A 2'' micro secondsO +ntensity A highest to era% e %y the participant. The contro gro)p recei,ed 43 min of p ace%o T$7S. A non cond)cti,e p astic fi m with no centra pore was p aced on the s9in o,er each ac)points. Participants co) d see the f ashing ight %)t no c)rrent was transmitted to the ac)points. "onfirmation of a%sence of e ectrica stim) ation emp oyed %y this method was o%tained %y fi,e participants prior to data co ection. $.7 0utcome measures ;)ng f)nction was meas)red according to American thoracic society g)ide ines 12 )sing a He ios I!S spirometer. 8orced e2piratory ,o )me in one second .8$V10 and forced ,ita capacity .8V"0 where )sed to meas)re )ng f)nctions. A tests were done in sitting position and the %est of 3 was recorded. Dyspneoa was tested )sing a ,is)a ana og)e sca e 13 which was ha,ing ' to 1'' mm sca e where Nero meant B7o %reath essness at a C and 1'' meant the worst sensation e2perience.

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Si2 min)te wa 9 distance was meas)red with the he p of si2 min)tes wa 9 test .:!<T0, performed according to ATS g)ide ines14. The :!<T is a practica simp e test that re@)ires a 1''#ft ha way %)t no e2ercise e@)ipment or ad,anced training for technicians. <a 9ing is an acti,ity performed dai y %y a %)t the most se,ere y impaired patients. This test meas)res the distance that a patient can @)ic9 y wa 9 on a f at, hard s)rface in a period of : min)tes .the :!<D0. +t e,a )ates the g o%a and integrated responses of a the systems in,o ,ed d)ring e2ercise, inc )ding the p) monary and cardio,asc) ar systems, systemic circ) ation, periphera circ) ation, % ood, ne)rom)sc) ar )nits, and m)sc e meta%o ism. !ost acti,ities of dai y i,ing are performed at s)%ma2ima e,e s of e2ertionO the :!<D may %etter ref ect the f)nctiona e2ercise e,e for dai y physica acti,ities. $.8 %ata analysis Ana ysis was done %y intention to treat. Statistica significance was reported as p ,a )e from independent t#tests. A statistica significance e,e was set at p P '.'3.

). Results
).1 'articipant 9lo# A tota of 33 participants .41!a e and 148ema e0 met the inc )sion criteria. The mean age was ::.3 years in e2perimenta gro)p and :?.3 in contro gro)p. !ean B!+ was 22.3 9gEm2 in e2perimenta gro)p and 22.3 9gEm 2. !ean > predicted 8$V1 in e2perimenta gro)p was =2.=?> .SD &.'20 and in contro gro)p it was =3.2:> .SD &.110 and mean > predicted 8V" in e2perimenta and contro gro)p was ='.4:> .SD 3.310 and ='.13.SD 4.4=0 respecti,e y. 1' participants .3=.'4>0 were e2#smo9ers ..i.e., they had stopped smo9ing for more than 12 months0, 13participants .4:.43>0 were c)rrent smo9ers and '3participants .1=.&:>0 were non#smo9ers in e2perimenta gro)p. 1' participants .33.=1>0 were e2#smo9ers ..i.e., they had stopped smo9ing for more than 12 months0, 1' participants .3=.'4>0 were c)rrent smo9ers and '=participants .23.?2>0 were non#smo9ers in contro gro)p. Both gro)ps were simi ar in terms of gender, age, B!+, :!<D, Dyspnoea and > Predicted 8$V1 and 8V" and a so medications. !edications prescri%ed were# theophy ine, sa %)tamo , ,ipratropi)m %romide or sa %)tamo with ipratropi)m as re@)ired. ).$ Effect of inter6ention A participants comp eted the tria witho)t any ad,erse effects. +ncrease in 8$V1 %y 4.3=> predicted .?3> "+ 2.=1 to :.'4, pG'.'30 8V" a so increased %y '.:3> predicted .?3> "+ #'.4' to 1.=1, pG'.'30 Si2 min)te wa 9 distance had increased %y 14.32 metres .?3> "+ 1'.:= to 1=.??, pG'.'30 and Decrease in Dyspnoea sca e %y 1.2? mm .?3> "+#3.'' to '.41, pG'.'30 was seen in the e2perimenta gro)p than contro gro)p $ffects of inter,ention in gro)p data as we as within and %etween gro)p data are presented in the ta% e 3 +a le ).-un& function, 7!:% and dyspnoea of e(perimental &roup and control &roup #ith mean 12%3 of each &roup, #ithin &roups and et#een &roups ; mean< 2% = C.I. %ifference %ifference ,roups #ithin &roups et#een &roups 0utcome 're 'ost 'ost minus pre 'ost minus pre E(p minus Con E(p Con E(p Con E(p Con -un& function 8$V 1 .> Pred0 =2.=? .&.'20 8V" .> Pred0 ='.4: 3.31 :!<D .mt0 324.1 3:.11 Dyspnoea S/B 3:.3 VAS .'#1''mm0 =.?: =3.2: .&.110 ='.13 4.4= 323.3 3=.4? 3:.?: :.=3 =&.:4 .3.?=0 =3.&2 4.:3 34'.2 33.1& 32.3 3.:& =3.11 .:.2=0 =2.&3 3.&3 323.1 34.13 34.22 4.43 3.&3 .2.?'0 3.33 2.42 1:.'= :.3= #4.'3 3.'= 1.4& .3.230 2.= 1.2? 1.=41 :.?3 #2.=4 3.2 4.3=Q'.&3 2.=' to :.'4 '.:3Q'.33 #'.4' to 1.=1 14.32Q1.&2 #'.4' to 1.=1 #1.2?Q'.&3 #3.'' to '.41

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*. %iscussion
The effect of sing e session of %i atera app ication of T$7S for 43 min)tes in patients with "/PD showed increase in 8$V1, :!<D and decrease in dyspnoea. This has %een reported in ear ier st)dies13,1:,1=,3. Dyspnoea which is the commonest symptom in "/PD is associated with increased %ronchia and systemic inf ammation1&,1?,2'. Airf ow imitation has %een associated with changes in e,e s of inf ammatory mediators s)ch as t)mor necrosis factor and inter e)9in#&21. !aier et a 22 showed that inf ammation increases cyto9ine e,e s which are transmitted to Hypotha am)s ,ia sensory pathways. Tracey23 fo)nd that a s)ppressi,e effect on the re ease of cyto9ines was ca)sed %y the re ease of Acety cho ine. "yto9ine synthesis is s)ppressed %y re ease of g )cocorticoids ,ia negati,e feed%ac9. Th)s, dyspnoea is red)ced %y s)ppression of inf ammatory mediators either ,ia afferent or efferent ,ag)s ner,e stim) ation. <hether decrease in dyspnoea is d)e to hypotha amic acti,ity associated with endorphin re ease was inconc )si,e in a st)dy %y Jen S; and A ice L! Rones3. Traditiona "hinese medicine pres)mes that dyspnoea is d)e to deficiency of f ow of MSi4 .energy0. Ac)p)nct)re techni@)e may restore the MSi4 %a ance and there%y red)ce dyspnoea 24,3. Tan and Horn23 did not get a satisfactory e2p anation of MSi4 f ow and %a ance in accordance to western medicine. <hi e Ta9eshige et a 2: spec) ated that ac)p)nct)re points stim) ation can modify respiration %y inf )encing the respiratory centres in med) a. Ro%st et a 2= and ;a) F *ones3 ha,e hypothesised that ac)p)nct)re stim) ates hypotha am)s which re eases endogeno)s opiates, there%y red)cing dyspnoea. Therefore opiates are prescri%ed to s)ppress respiration which mod) ates the sensation of %reath essness2&. *.1 Effect of Acu-+E/2 on lun& function Vario)s criteria for e,a )ation of short term response to a %ronchodi ator are fo)nd in different st)dies i9e T 13> impro,ement o,er pre#%ronchodi ator 8$V1 2?, T 12 > impro,ement p )s an a%so )te ,o )me increase of T 2'' m 3' and an a%so )te impro,ement o,er pre#%ronchodi ator 8$V1 of T 1'> predicted ,a )e31 An increase in 8$V1 %y 4.3= > more after Ac)#T$7S than p ace%o T$7S was fo)nd in this st)dy. This impro,ement did not reach these standards. There is no direct action of Ac)#T$7S on airways %)t the effect may %e thro)gh centra processing of ne)ra signa s. This st)dy showed that Ac)#T$7S impro,ed 8$V1 %y near y 3 > more than p ace%o T$7S. Howe,er this impro,ement did not reach the (/;D standard set for B%ronchodi ator e,a )ationC. !oreo,er a red)ction in dyspnoea score %y 1.2? mm more than p ace%o T$7S is a so significant. 8V" was impro,ed in Ac)#T$7S o,er P ace%o T$7S %y on y '.:3 >. This was statistica y insignificant. A c inica y significant change in 8V" was not e2pected with one session of Ac)#T$7S. Short#term reprod)ci%i ity of the :!<D is e2ce ent with a good @)a ity#ass)rance program, with patients tested %y the same technician, and after one or two practice tests 32. ATS g)ide ines recommend that change in :!<D can %e e2pressed as an a%so )te ,a )e. ATS g)ide ines a so state that statistica y significant mean increase in :!<D in a gro)p of st)dy participants is often m)ch ess than a c inica y significant increase in an indi,id)a patient. +n one st)dy of 112 patients .ha f of them women0 with sta% e, se,ere "/PD, the sma est difference in :!<D that was associated with a noticea% e c inica difference in the patients4 perception of e2ercise performance was a mean of 34 m .?3> confidence inter,a , 3=A=1 m033. <hi e in this st)dy a%so )te increase of 14.32 metres was fo)nd in :!<T in Ac)#T$7S gro)p as compared to p ace%o T$7S gro)p.

5. -imitations

The se,erity of "/PD of the participants was mi d to moderate. +t sho) d %e noted that the effect of Ac)#T$7S on patients may %e more significant and dramatic if patients had high e,e of dyspnoea. $ffect of on y sing e session of Ac)#T$7S in "/PD patients was foc)sed in this st)dy. Participant4s dyspnoea may not ha,e ret)rned to norma resting e,e s as most participants tra,e ed to the centre %y p)% ic transport and had to wa 9 some distance to reach the centre, despite 3' min)tes of rest %efore the )ng f)nction

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meas)rement. The effect of Ac)#T$7S or p ace%o T$7S o,er ac)p)nct)re points was compared in this st)dy rather than its app ication o,er non#ac)p)nct)re points. So, it was inconc )si,e that whether the positi,e effect of Ac)#T$7S was Ac)#point specific or d)e to the genera effect of T$7S. S)a ity of ife was not meas)red, a tho)gh )ng f)nction is re ated to dyspnoea and it does determine a person4s @)a ity of ife.

7. Conclusions
This st)dy conc )ded that compared to p ace%o T$7S, %i atera app ication of Ac)#T$7S at ac)p)nct)re points $K#B1 for 43 min)tes in am%) atory patients with "/PD ead to an impro,ement in dyspnoea, :!<D and )ng f)nctions. T$7S is a non#in,asi,e )ser friend y, ow cost e ectrotherapy moda ity. App ication of T$7S may he p dyspnoea management in patients with "/PD and there%y impro,e @)a ity of ife. The %eneficia effect of Ac)#T$7S in this st)dy s)ggests that Ac)#T$7S may %e a )sef) a ternati,e approach for the management of patients with "/PD.

8. 9uture Recommendations

The comparati,e effect of high T$7S and ow T$7S on "/PD patients can %e st)died. The effect of Ac)#T$7S on non ac)points in "/PD a so can %e st)died. The comparati,e effects of Ac)#T$7S and medications on dyspnoea can %e st)died ;ong term effect of T$7S on fre@)ency and se,erity of "/PD S)a ity of ife impro,ement can %e one of the parameter to st)dy the effect of T$7S in "/PD patients

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