rct- rhizotomy and pt for spastic cp

7
 A randomized clinical trial t o compare selective posterior rhizotomy plus physiotherapy with physiotherapy alone in children with spastic diplegic cerebral palsy A randomized controlled single-blin d trial was performed to compare lumbo-sacral selective posterior rhizotomy (SPR) followed by intensive physiotherapy, with intensive physiotherapy alone in improving motor function in children with spastic diplegic cerebral palsy. Fifteen patients were randomly assigned to each treatment modality . Patients in the SPR group had rhizotomy within 1 month, followed by intensive outpatient physiotherapy for 9 months. Patients assigne d to physiotherapy alone had identical intensive physiotherapy. There was a statistically significant and clinically important difference in improvement in motor function in favor o f the SPR group, with a mean increase in total Gross Motor F unction Measure (GIMFM) score of 11.3% at 9 months for the SPR group compared with 5.2% for the physiot herapy-only group (P =O.OW) ignifica nt improvements in spasticity (P <O. OOl ) a nd range of movement (P<O.OOl) were noted n the SPR group compared to the physiotherapy-only group. The results indicate that the improvement in motor function after SPR is more than can be explained by he associated intensive physiotherapy. Selective posterio r 14iizotomy (SPR) s currently perfoi-nietl n many centcis for tlie t reiit ment ofsl,:isticity aso ria tetl with wre1)raI palsy (C'P). with the uiin of rctlucing spasticity ii~itl increiising range of movenient iii tlic lower liinbti. with the t*sl)ectatioii liilt this will improve tlie motor fiinction of the child. Ft~vorable esults liiive bwn iq)orted after this opera- tion by inany workers in the fic4tl (F no ct aI. 1980. Peacock iintl Staotlt I )91.Steinl)ol<et l. 1092,Alhottet ill. 1993. Pai*I< et :I]. 1993. Peter t\nd Awns 19 )3. ;\lcLaiiglilin ct ill. 1 )94. Albri ght ct d. 9%). Son e of t ie above reports litis been basctl oil 1-antlomized cli nical trid s. and it has not been ~~ossible o noted rny proret1ui.e 1retl ue o tlicopei*tition tselfor to the intensive pliysiotht~apy hat is ~isiially ivcw after SPR Landau aiitl Hunt 1990. (;iuliani 1981. Park antl Owen 1992. JIcLariglilin et al. 1994). Tlre objective of this stiitly was to tleteriniiir \vIietlicr luiiibo-sncr~~l P R ollo\vctl by iiitensivr pliysiotheriipy was inoir ef fective han int eilsive pliysiotliei~~ipy lone in iiiil)i~.~- ing tiiotoi.fiinc'tion n rliiltli~cn with sp astic tliplegic ('P Method This WS a single-centre rnntlonii zed single-b lind t rial coinpar- ing two ti'ratiiiciits for loi\ei* -limb ptist iiity : SPR pliis inten- sive pliysiotheixl \r: ant1 intensi ve physiotherapy alone. The st u(Iy WIS (Iesigiird o wnipare t Iir efficacy oft iese two treat- inents in improving the gross niotoi- function of rliildir~i iiioiitlisaftei.ti,catineiit. The total score of the Gross Motor Fiinctioii Aletisure :;\I FJI) \vas chosen as tlie primary outcome meas\ire for this study bec*ause t was the only fiiiictional assess ment tool tha t lid becn stantlaidizecl antl \ditlatetl for use i n chiltli~n with sl'astic('P(llusse1lct HI 1989, Haleyet al. 1991). The study was eontluctetl at British ('olumbia's C'hiltlren's Hospital. t lie only tertiary rare refel-ral c~hiltlreii's ospitiil i n the piw inc e of Britis h (401i ~nibi a.Ttie tudy was approved by tlie Etliics('oaimitt~eoft1ic University of British C'olumbia. Fifteen chiltliwi were raiitlomly assign ed t o each win oft he st idy. One child in eavh group tlropped out after rantlomiza- tion: the parents of one cliiltl nssignetl to tlie pliysiotIieiq>y- only group tlecitletl that they wer~ ot l)reparetl to wait for surge ry later. iintl tlie ~~ar~iitsoftlieotliercliiltl ssig ned to th e SPR group later irfiisetl rhizot oiny. C'h iltl ren i n th eSPR group , ranged in tige froiii 35 to 75 months (mean 50 montlis. median 47 months), antl i n the coiit rol gi-oup from 35 t o 77 months (iiiean 47 months. median 42 nionths). Sis children \vho were potentially eligib le w er e not entered into the study, but \ve nt on t o undergo a rhimtomy Three of these patients did not meet all tlie eligibility criteria: i n two c-ases here was ineertainty about the availability of intensive pliysiothera~?y.ntl for m e rhiltl witli significant hip sublusa- tion there was concern about tlic po~sibilit~y fa delay in surgi- cal treatment. The other three cliiltlren were eligible for the study but the parents refused to participate. preferring instead t o proreed to an electively schetl uled rhizoto my. The comparability oftlie treatment and control groups was assessetl by esamin ing baseli iie measurements of all the out- come measures, inclutling GMFAI, Physio logica l Cost In tles. Peabotly Fine Motor Scale . self-car e assessment score antl 10 measuirs of range, spasticity and strength.The re were n o sig- nifirant cliffeirnces between the two groups at baseline I)ESI(:S AS11 SK'I"I'IS(:

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Page 1: RCT- Rhizotomy and PT for spastic CP

7/18/2019 RCT- Rhizotomy and PT for spastic CP

http://slidepdf.com/reader/full/rct-rhizotomy-and-pt-for-spastic-cp 1/7

A randomized

clinical trial

to

compare selective

posterior rhizotomy

plus

physiotherapy

with physiotherapy

alone in children with

spastic diplegic

cerebral palsy

A

randomized controlled single-blind trial was performed to

compare lumbo-sacral selective posterior rhizotomy (SPR)

followed

by

intensive physiotherapy, with intensive

physiotherapy alone

in

improving motor function in

children

with spastic diplegic cerebral palsy. Fifteen patients were

randomly assigned

to

each treatment modality. Patients in

the SPR group had rhizotomy within 1month, followed

by

intensive outpatient physiotherapy for 9months. Patients

assigned to physiotherapy alone had identical intensive

physiotherapy. There was a statistically significant and

clinically

important

difference in improvement

in

motor

function in favor of the SPR group, with a mean increase in

total

Gross

Motor Function Measure (GIMFM) score of 11.3%

at 9 months for the SPR group compared with 5.2% for the

physiotherapy-only group (P=O.OW) ignificant

improvements in spasticity (P<O.OOl) and range of

movement (P<O.OOl) were noted n the SPR group compared

to the physiotherapy-only group. The results indicate that the

improvement in m otor function afterSPR ismore than can

be explainedby he associated intensive physiotherapy.

Selective posterior 14iizotomy(SPR)

s

currently

perfoi-nietl

n

many centcis

for

tlie treiitment ofsl,:isticity aso ria tet l with

wre1)raI

palsy

(C'P).

with the

u i i n

of rctlucing spasticity i i ~ i t l

increiising

range of

movenient

iii

tlic lower liinbti. with the

t*sl)ectatioii liilt this

will

improve tlie motor fiinction of the

child. Ft~vorable esults liiive b w n iq)orted after this opera-

tion

by

inany workers in

t h e

f i c4 t l ( F no ct aI. 1980.Peacock

iintl Staotlt I )91.Steinl)ol<et l. 1092,Alhott et

ill.

1993.

Pai*I<

et : I ] . 1993. Peter

t\nd

A w n s

19 )3.

;\lcLaiiglilin ct i l l .

1 )94.

Albright ct d.

9%).

Sone of t ie above reports

litis

been

basctl

oil

1-antlomizedclinical trid s.

and

it has not been ~~ossibleo

tlrterininr \vIietlierthc positive rrsults noted after the ihizoto-

rny proret1ui.e 1retlue o tlicopei*tition tselfor to the intensive

pliysiotht~apy hat

is

~isi ial ly ivcw after SPR Landau

aiitl

H u n t 1990. (;iuliani 1981. Park

a n t l

Owen 1992. JIcLariglilin

et

al . 1994).

Tlre

objective of this stiitly was to tleteriniiir \vIietlicr

l u i i i bo - sncr~~ lPR ollo\vctl

by

iiitensivr pliysiotheriipy

was

inoir ef fective han inteilsive pliysiotliei~~ipylone i n

i i i i l ) i ~ . ~ -

ing tiiotoi.fiinc'tion n rliiltli~cnwith spastic tliplegic( 'P

Method

This

WS

a single-centre rnntloniized single-blind t rial coinpar-

ing

two ti'ratiiiciits

for

loi\ei*-limb ptist iiity:

SPR pliis

inten-

sive pliysiotheixl \r: ant1 intensive physiotherapy alone. The

st u(Iy WIS (Iesigiird o wnipare t Iir efficacy oft

iese

t w o treat-

inents i n improving the gross niotoi- function of rliildir~i

iiioiitlisaftei.ti,catineiit.

The total score of the Gross Motor Fiinctioii

Aletisure

:;\I FJI) \vas

chosen

as

tlie primary outcome meas\ire for this

study bec*ause t

was

the

only

fiiiictional assessment tool tha t

l i d

becn stantlaidizecl antl \ditlatetl for use i n chiltli~nwith

sl'astic('P(llusse1lct

HI 1989,

Haleye t al.

1991).

The study was eontluctetl at British ('olumbia's C'hiltlren's

Hospital. t lie

only

tertiary rare

refel-ral

c~hiltlreii's ospitiil i n

the piw ince of British (401i~nibia.Ttietudy

was

approved

by

tlie

Etliics('oaimitt~eoft1ic

University

of

British C'olumbia.

Fifteen chiltliwi were

raiitlomly

assigned t o each w i n o f t

he

st

idy.

One child i n eavh group tlropped out after rantlomiza-

tion: the parents of one cliiltl nssignetl to tlie pliysiotIieiq>y-

only

group

tlecitletl that they

w e r ~

ot l)reparetl to wait

for

surgery later.

iintl

tlie ~ ~ a r ~ i i t s o f t l i e o t l i e r c l i i l t lssigned to the

S P R group later

irfiisetl

rhizotoiny. C'hiltlren in theSPR

group ,

ranged i n tige froiii 35to 75 months (mean50 montlis. median

47 months), antl

i n

the coiitrol gi-oupfrom

35

to 77 months

(iiiean47

months. median 42nionths).

Sis

children

\vho

were potentially eligible were not entered

into the study, but \vent on to undergo

a

rhimtomy Three of

these patients did not meet all tlie eligibility criteria: in two

c-ases

here was ineertainty

about

the availability

of intensive

pliysiothera~?y. ntl for m e rhiltl

witli

significant hip

sublusa-

tion there was concern about tlic po~sibilit~yfadelay in surgi-

cal treatment. The other three cliiltlren were eligible for the

study but the parents

refused

to participate. preferring

instead t o proreed to an electively schetluled rhizotomy.

The

comparability oftlie treatment and control

groups

was

assessetl by esamining baseliiie measurements of

all

the out-

come measures,

inclutling

GMFAI,

Physiological Cost Intles.

Peabotly Fine Motor Scale. self-careassessment score

antl

10

measui rs of range, spasticity

and

strength.There were

no

sig-

nifirant cliffeirnces between the two groups at baseline

I ) E SI( : S

AS11

SK'I"I'IS(:

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(Table I ) . All i*liil;li~en at1 been receiving active supportive

tlieixpv. with

a

minitnuin ofonc session \vcchly with

a

physio-

therapist. bcfoieent iy t o tliestutly.

”lie

amount of pliysiot lierapy given by a physiotherapist

overtlie ) montlisoftliestutly

areragecl81.8

houi-s

range72

to

90hoars) fortlieSPR group,

coiiq~i~rctl

ith 81.3 hours(iange

5 0 to

89 hours) tor

the

I)11?.siotlieral)?.-oii12’

roup.

For the chiltltwi untlergoingSPR, the

iiiettii

perwntagrs

of

tli r posterior i-oots cut were

58%

for I,?.

L3. L5

and S1 coni-

l)inrt l,42% for

U

nd4O% forS.2.

Potential subjects

NCW

iwiewetl by

a n

orthopedic surgeon.

neurosurgeon

intl

I)liysiotliei.al)ist o tlrterminc wliether they

were eligible for the study i n fiilfilliiig the follo\ving (*riteria:

spastic. dipkgic.

C‘I’

with no athctoid

or

ataxic component to

their

neuromuscular

I)roblem:3 to 7 prilrs of age: spasticity

severeenough to iinpair grossmotor fun d on;SPR considered

to be appropriate for the child: able to sit on the edge of an

csarnii i ingtablc\vitl~armsin

licairiindabletostRtitlupwliilr

lioltling

on

wit 11 tlicii- Iiantls:intciisi\.e pliysiotherapy i n ~ic(-oi*-

clance with tlie study protocol available i n tlie

rhiltl’s

Iionir

community:antl parents coiisentetl to tlie cliiltl being

rantloni-

ly assigned to

one

oftl ie two

groups.

Patients were esclutlrtl if

there

was

a

plannctl

surgical

procetlure

(orthopetlic

o r

other-

wise) (luring the period of the study o r if it was fclt by the

assessois that the c*liiltls

piddeins

\wreo fs~i ch everity tha t

11

9-month delay i n performing a definitive p r o w l u r e might

c.oinpt-oniisc he child‘s health

(e.g. f

the hips

were sublusetl

significantly). Parents were inforinetl that both the pliysio-

therapy alonc.

and

the

8PR p l u s

physiotherapy

had

the poten-

tid to improve the child. aiitl that if the child

was

assigned to

th e I)liysiothcral)y-only arm of the s t d y the child \voultl be

able t o

have SP&

at

the

rompletion of the study if

the

pliysi-

cians and parents fclt that this

pi-ocetlure\vas

still intlicated.

C‘hiltlren who were entered into the study uere rantlomly

assigiietl to eitl iergimip I1vusinga random

nuinbers

able.Tlie

rtuitloiiiization was

I)erformetl

hy

an

intlepentlent party not

involved with the careoftl ie patient.

P I <

O(‘E1 c‘ I E

C‘hiltlren srlccbtetl for SI’R hat1 the operation perfomed w ith in

1

m o n t h

of being assigned to the group. I’ostoperativc nian-

ageiiierit was stantlartlizrtl.with gri ~Iua1 obilization after48

hours of bed rest. itnd discharge on tlie 8 th postoperative day.

~’hiltlren hen ieturnetl t o their home where they iweived

int

ensive pliysiotherapy.~I l i i l t l i r n ssigned to the pliysiotheiapy-

only group started their intensive physiotherapy prograiii

within 1 month of being assigned, antl iweivecl the stinie

amount ant l type of pliysiotherapg as the

SPR roup.

(‘hiltlrcn

i n

both

study

groups received intensive

pliysio-

the rapy

3

times

a \veek

for 3 months.

antl

twiw

a week

for

8

months.

using

equi\~alent

tee-liiiiqurs

of treatinent.

Physiotherapy ronsistetl of passive raiibv of motion of the

joints of the

lower

liiiibs:strrii~Iieiiingo hip abductors

and

rstrnsors. liner estensors.

and

ankle tlorsiflesors: and for 40

iiiinutes of each 1-hour session. the Imwtic*eof normal ]jilt

ten^ of iiiovenieiit based on 1ieiirotIe~r1o~~m~iitalheory

(Bo1)ath 1967). Bec*uuw he usual protocol afterSPR involves

niuch stantling

and

ivalking, tlie physiotherapist t ivating

each

child i n the physiotlier~~py-onlyroup \vi\s instruetetl to

plarr

as

much rinphasis on \vcightbearing as if the eliiltl

h a d

under-

goneSPR.A h o m c ~)liysiotlierapy i’ograni.as outlined by t h e

study pliysiotlierapist.

was

taught to pitiwits

a i d

monitorctl

by the child’s coininunity I)liysiotlicral)ist. Records of t he

pliysiotherapy sessions were Itrpt by tlic paiviits

and

by the

I)liysiotlieral)ists.

and these \vcrc provided

to t he stutly rooidi-

Ilator.

SPH involved partial posterior ihizotomies fiwii IA to S?.

via laminotomics from L1 to SI.EHCII osterior root was split

into thiw to

sis

I-ootlets.

acdi

of ivhic-liwas sti~nulatctl

vi t Ii i i i

l r m of the root exit fi)ramt~nwith two unipolar r4ectrotles

(;\lodified Insulatetl Ball 1)issc~tors;

Xescwlop

Surgical

Instrunients. Burlingame,

(‘A,.

USA).

Re(-ortlings~vcrenatlr

with silver/silvcr tdiloritle elet.trotlcs applied over the

muscle

bellies of tlir ~ i i p t~t~u;-tors.;istus iiiet~ia~is.i1)iiiIis anterior

anti

gastrocnemius

i n

tIie

~ o w r

imbs, deltoitls

and

cxtciisor

tligitoruin coniniuiiis

i n

the upper limbs,antl sternoc~leitloinas-

toitl ant1 massctcr.Tlie hi~Aio ldora i~sl)oi,se\viisitlciitifirtl

y

Table

1: Mean

baseline values and 95% CI for all outcome measures

in

both groups.

Gal Fa1

I 4

Physiological

Cost liitles 6

1’e;ibotly scorc 1.4

Self-caw

aqsessinciit

scow 1 1

Spasticity

.\sh\\ortli score)

H i p atltlurtors 14

Kncr

flcxors 1

Ankle plantarflesors I4

Hip al~ t luctio i i 14

ICiireest~iision

I4

Roiigc. o f inotioii (tlrgrers)

I5

1

.i

1.5

15

I5

I5

15

1

G0 i

1

.o’i

513

44.8

3.36

2.9

4.0

25.8

138.3

(51.4-iO.0)

(2.7

(0.67 1 . 4 i ) I .03

484-54 ) 508

(29.7-60.0)

37.4

(3 O-S. i 3.

(2.2- 3.6)

2.ti

(Xi-4.3) R.4

(20.8-30,s)

3 1

I

I29..>-11i.

I ) I443

( 5 4 . 4 - - i l O)

(0.46-139)

(.485--531)

(24.7-50.1

)

(2.7-3.5)

( 1 ..5-3.’7)

(2. I-3.i

(2ti.O-9ti.9)

1Xi.j-

152.0)

-

Ankle tlorsiflesion I 4

- 1 1.s

(-11.1-5.3)- ’ -14.1

( -49.5- 1.3)

Knee

estensors

1 *5

i 0 (4.0-10.0)

ti.5

(4.5-8.6)

H i p

extensors

5

1

2.1 0. - 3

5)

1 .5 0.1-3.0)

H i p

abductors

> 5

2.5

( 1.3-3.8) 2.6 I .3-3.8)

Ankle

tloiniflesors

7

1. ) (0.6-J.1) 1 .H (0.3 3.3)

Niincle stinigt Ii (kg orce)

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LI

8

J

I

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whether there was an inc is ion on th e back , and t he paren ts

were specif ically instructed not to indicate to th e assessor

what t r ea tment the rliilcl

was

receiving

o r

had received. The

assessors were instructed not t o discuss the possible treatm ent

of

th e child

or

results

of

the assessment wi th the paren ts. All

outcome assessment sessions were monitored for inadver tent

breaks in th e blinding protocol.

The total . score of the Gross Motor Function Measure

(GMFM) was chosen as the p r imary ou tcome and end po int of

th e study. Th e validity reliability an d responsiveness

of

t h e

GMFM have been demon strated i n

a

populat ion of patients

similar

to

those that were s tudied (Russell et al. 1989.

AIcLaughlin e t al. 1994).Assessments

\WIG

performe d by

phys-

iotherapists who had been trained i n t h e

use

of the GYFXI i n

children with ( I?

A numbe r of oth er parameters were

assessed as

secoiitlary

1 .

hIuscle

s t r eng th (kg)

o f

hip extensors , abductors ,

quadr ireps

and

anltle tlorsiflesors with tlie use

of a hand-held

myonieter

( H y l e

e t

ul . 1983).'I'Iiis

nieasiiw was used to

assess

only those patients d i n weir able to coopcrate adequately at

the ime of the in i t i a l assessment .

1.

AIuscle tone of hip iicldurtors. k n w flexors itnd

anltle

plan tar f lexors with the usc of a inotlifictl Ashw orth scale

( ~ o h a n n o n a n d S n i i t h 087).

3.

Range of motion at hips. knees i i t ld ankles meusurctl

with

a

goiiioineter using sta nda rdized aiiatomic.al

landmarks

and t h e m e t h o ds as proposed by tlie Aniericwi Aratleniy of

Orthopedic Surgeons (American .\c-adeiny

of

Orthopedic.

Surgeons 1965).

4.

Physiological Cost

I

titles, \vhich

iiiotiitorssl)rctlof\\,all~-

ing and heart-rate simultaneously. antl conibincs these two

parameter s as

an

intles of

lo(-omotor

function. The nieusuir

outcom e measures:

has been shown to be relialde and sensitive to tlie incwasc4

Table

IIE

Mean change and stanbarrldeviation of the change (SD) between the values at

baseline

and

9 months for the secondary outcome measures for both

groups

PliysiologicalCost Index

Peabody

score

Self-carr

assessnientscan.

Spasticity (Asliwvorthscore)

H i p otltluctors

Knee flexors

Ankle

p l a ~ ~ t a r f l c x o ~ ~

Rangeo f

motion (degree s)

H ip addurtors

K n e e flexors

Ankle plantarflexors

BIusc l r

strength kg orce)

Knee

extensors

H i p abductors

Hip rxtensors

Ankletlorsiflesors

G

0.3

0.15

5 4 . 2 7

0.48

4 . 1 4

0.89

14

22.4

20.2 I4 17.4 15.4 0.73

0.48

14 10.5 1 0 . 1 14

1 1 . 5

7.5 -0.28 0.78

14

-1.4 0.6

14

0.3

0.ti - 4 . 8 6 < 0 . 0 0 1

1-1

- 1 . 1 0 . 5

14

4 . 1 0 5

I4

-1.5

0.6

14

0 0.8

I4

15.8

10.6

I4 -3.3

8.6 5.24 <O.OOI

14

I5.ti

15.6 14 -2.1

10.9

i I8

5.9 2 15.3 14.1

7 0.2

1.5 ,5

0.7 1.5

4.48

0.G4

0.5 1.2

4 . 2 0.6

5

0.9

1 .0 5

0.5 1.2

>

1.3 1 . 1

5

0.ti 1 4

Positive nunierical changes ndicate iinprovcinent ai d

for all outcome i n r i i s ~ i r ~xcrpt

1'11ysiologicnI

Cost Index

antl spasticity SPR

=

SPK AUSpliysiot

Iicrapy

group. I'liysiotlirri~~~ypliysiotlirropy-

only group, S

=

Suinberofsubjects

assess~l .

>

Table

W

mbulatory

s t a t u s

at baseline

and

at 9 months

for

both

groups

All

children

could

\valk

antl

were categorized in order

of

iiwwasing funct ion.

as

ualk ing wit

Ii'hantls

I i e l t l ' , ' w ~ ~ a l k r r ' . ' c r i ~ t c l i e s ~ o r ~ u ~ i ~ u ~ ~ ~ ~ o r t r ~ l ~ .

I'K

=

SI'R

plos

physiotherapygroup. Pliysiotlieriipy = pl~ysiotliera~~y-oiilyroup.

Selw tive Posterior Rliizotoiny

Versus

Pliysiot l~cr~il~~*

'S/r i~rbok

/ RI.

181

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pliysiological tleniantl ofwal king in those:\ it lispa sticity oftlie

lo\\ .er li inbs (B ut lr r ct

al.

1984). I t VW used t o

assess

only s u b -

jectswlio

were able

t o viilk (iiitle~)c ii(lc.iitIyo r ith uicls)wt first

aSSCSsIllCI1t

3 . T h e Peabody Fine J lo to r Scale.

a

staiid aidiz ed nieasiii’e

offine niotorfunc*tion (St okc set

;iI.

1990 .

6. A

locally tleveloprtl,

iioii-staiidurtlizrtl. ciitcrion-iefei.-

encctl evid1Ia tion o f sd f - c ; ~ ~~ e.

7.

.-\nlblllator:\.s ta tus .

A

sample s ize

of

15

chiltlren

per

group

was

t letwii inet l

on

the basis ofexp wtetl score rhanges on h e GJIFAI and t h e ~ I Y -

violis \voikofRiissell et al. ( l9$9). ivho r epor ted tha t

ii change

in score of 5.1% iq) i~eaentct l

n

ml~roven ien t

f

modera te to

major cl inicd inipor tance. Because o f t Iir iuvasive nature of

t h eS PK i t

was

f el t tha t t o justify t h e s u i * g e r ~ne \voultl

need

t o

show a

tliffeiwice between th e

$PI1 group and

tlie pliysio-

therapy-only

group

t h a t was of

niotlerate

t o

nitijor

clinical

inipor tance in favorof theS1’R

group.

Such a clinivally iinpnr-

ta nt dilfeiwice required th at the re slioultl be an inlwownient

ofa t least 5.1

%

in the GJIFJI

score

i n filvorofSI’11. Fi-om h e

sample

size estim ate of

Russell

e t

al. (1989)

t

was

es t imated

tlitit 15chiltlivn pergroup

w r c

r q u i i - e d o te st th e hypot h i s

a t

a

po”rrof90

a n t l

a

=

0.05.

.A

SA

YS s

T h e

nieaii

change in

(;lIFAl

SCOIT froni baseline to 9 months

in

the two groups was coniparcd with the t t es t f i ~iitlepentlent

means.

A

number of

secondary outcomes w e i r anidyzetl.

including

lower-linib

muselr

strength,

spasticity

antl range

of

motion: Peabotljl Fine Motor Scale; Physiological Cost I

ntles:

antl t h e rriterioii-ipfei.eiicrcl

nieasii,re

of self-rare. I n these

analyses. continuo us measure s were roml)aretl with t tests for

intlepen(ltwt ineans. -4s n ou r previoiis work (Ste inbok e t aI.

1999). one nieasure each of spastiritj: range

of

motion,

antl

muscle s t r eng th WIS

chosen

beforehand for s tat is t ical iinaly-

sis. For spast ici ty , hip a t lductor spast ici ty was rliosen because

it

is

functionally kignificant

and

geiierallg repesentat ive of

the overal l degree of lo\vrr-liinb spasticity. For range o f

motion. hip abduction \\.as chosen because it is functionally

significant ai id relates to th e hip at l t l i i r tors I )ast ici t~Formus-

cle s t r eng th ,

the

knee extensors were chosen because these

muscles are important for s tanding arid walking. The two

treatment groups

were

conil)ared on each of these three m ea-

sures. and a Bonferoni vorirction for multiple m np ai iso ns

was

used

(P=O.05/-&=0.OI%

vasaccepter l ss igi if icant) .

>IOSITORIS :

F STVI)S PROTO(’0L

A11

c.hildren eligible for t he stu dy

were

accounted for,

aiitl

if

t h ey d i tl n o t en t e r t h e s t u d y h e ivasons foi~tliis\\~ei.eitIentifietl.

Children n4ioenteivtl t lies tud y bu t wit htlrew

early

were itlenti-

fiecl

a i d

th e wa sons for withdrawal tlocumentetl. Caregivers

were atlvisetl not toinst i tute addit io nal t rea tme nts for thech il-

dren dur ing t h r course of the s tudy,

antl

this

was

monitored

throu gho ut thestu tly to tlentif) any possible lion-compliance.

Results

The mean increase

i n the

to ta l

GJIFII

score at 9 months was

1l.Yh

95%

CI . 7 . J to

I5.2)fortheSPRgroupcoinpareclwith

5.2% (95%

‘1.

3.1 t o

7.2)

for th e physiotherapy-only group,

for a cliffereme in means of

6.1

%.T his difference between th e

means for th e two

groups

\\‘assignificant

( t =

3b3. P = 0.007).

PKI. \IAkT OUT(’0MIC

182

f ~ ~ i ~ / f ~ ~ ~ ~ ~ i ~ t i / f i ~\Iw/ic;t ip ck (%i/tlSeir,olo / / 1997.39, 158 184

T h e ck t a il h o f t he intlivitluid assehsn ients. acco$ng to each

of t l ie f ive dimensions tha t com prise thr t o t a l

GJIFAI

score.

aresh n ivn

inTaible 11.

SE(Y ts 1)A

RY

0rIY V) . \ I ES

There WIS a t l i f feiwce bet\vecn th e two

groups

i n t h e improve-

nicnt i n spasticity. as nieiisriiwl i n

thr

hip ;dt luctors . with a

nwiiii tlecrrasr in spast ici ty of

1.4

uni t s on he;\sI inor th scale

f o r t h eS PR g r o up eomp~i~etlith 0.3 units f or th e pliysiother-

apy-only group. This diftei’cnce

i n

nietuis

was

significant

(I’<o.(H)I

).

Change i n

spnsticitx i n o t h e r

muscle

group

fol-

Io~vetl

I

sin>ilar pat tern . tis shown i l l ‘liible I l l . There was a

gi,eater improvement

i n

t h e

range

of niovrment. as mrasui.etl

by

hip abduction. i n th e pat ients having

SPR

15.8” ) h a n i n

those receiving pliysiotIici*tq)y(-3.3’).

The

tliffcmice i n tlie

mean

cliange between the two groups isas significant

(P<(J.OOI).C‘hanges in range of iiioveiiient a t oth er joints H I T

tletailetl in‘I’able 11I.The~u:\ a s no tliffervnce in the

change

i n

ciundriceps sticngtl i bet\vecn th e two

gi’oups

P

= O. it).

group

and

t lie I)Ii.ysiotIierai)y-oiiIy roup wi th r espect to th e

Physiological (lost

Index,

Peabody Fine Notor

Sciile and

self-care assessinelit

scor(b

(Table

I I

I).

There were technical

pi~nbleiiiswith t he Physiological C‘ost Intles, i n tha t the r es t -

ing

l iear t rate

\FUS

variable between assessments, making

interpretat ion of th ed at a dif ficult .

I n

heSI’K gi-oup, mbula-

tor y s ta tu s ini l) rovcd

i n

five of th e 1 0 chiltlirn

who

iveir not

walking intlepentlently

at

their initial asscssiiient. whe rras no

patient i n the physiotlieral)y-oIily group

had

an improved

level of anibula tinn (Ta ble

I V ) .

Al l patients in t he ~ ~ l i y s i o t l i ~ r a ~ ~ y - o n l yroup \vent on t o

IiiweSPR af ter the conelusion o f th e

studjr.

T h e w n p r e no coin

pl

i r a t ions i 11 th e pliy siot hera

py

-only

group. I n heSl’R group there

was

one postope rative infection

with a spinal epidural abscess and one case

with

t ransir i i t ur i-

nary

retention, ahicl i iwolvctl by the four th postoperat ive

day

One

child. at 9 months af ter SPR. complained of

back

pain , nhieh resolved spontaneously within 2 (lays.

S o

patient

on

t h e study

was

given adtlitioiial thcra pies ou t-

side th e pivscribetl stu dy proto(*ol.Their as onc protocol non-

compliance with respect t o th e blinding process for the outcome

assessments. and

because

t h a t occuriwl a f t e r t h e final assess-

.

nient for the pa tient no corrective

nieasures npre

necessary.

Discussion

Althoug h there have been no pe vi ou s riintlomized. controlled

studits . analyses of outcome af ter SPR have been reported

froni many centers. Spasticity

antl

range of movement

i n

t h e

lo\ver limbs have consistently

been

r epor ted to improve af ter

SPK

(Peacock

ancl Stautlt 1991:Ste inbok c t H I 1992. 1995;

Park et

al.

1993: AIcLaugIilin e t al.

1994:

Alarty et

al.

1995;

Sish i t la e t al. 1995). Iniprovemeii t i n ambula t ion

has

been

tlemonstrated quali tat ively (Steinbok et al. 1992, 1995:Peter

antl Arenu 1903:AIarty e t al. 199 5;Sis hitlae t al. 1995) antl w ith

formal gai t analysis techniques (Peacock and Stauclt 1991,

Vauglian et al.

1991,

Boscar ino et al. 1993). Functional

improvements af te l -SPR have beenshown by using assessm ent

ttwls. such

as

th e Pediatric Evaluation of Disability Inven tory

antl GAIFY (Bloom ancl S a z a r

1994,

\IcLaughlin et al. 1994).

In many re por ts th e importanc e of intensive postoperat ive

physiotherapy

is

stressed

(Peacock

e t

H I

1987.

Abbot t, e t al.

198 3.

Steinbolc et al.

1992,

JIcLaughlin et al. 1994). antl

There wis no

signif ici int t l i f fcrcnee betwen the SI’R

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although tlic protocols vary from one center to another. SP R

is typically followed by more fi*eq ucntpliysiotlierapy sessions

than ~ v a s eing provitletl I);.col)~,i'ati\.cly

P

Strinbok.

unpub-

l ished dat a). Furtherm ore. th e postopei-ative thera py often

.

differs from th e usual physiotherapy for children with spastic

diplegia,

i n

that more empliasis

is placed

postoperatively on

strengthening the lower-li n b musculat we, ancl pract ising

staiitling and walking. a s ol)posetlto stretch ing exercises for

lo\vei--limboints antl muscles.Tlius. even

if

one accepts on t h e

basis of the previously tlcsciibetl iioii-i.aiitIotiiizet1st utlies.

tha t SPH does improve spasticity and range of movement

i n

the lo\ver limbs.

ant l

does inipiwc function of the child. it

coultl

betho t the iml)rovei i ientsarrnot l ie i*esul t f theope ra-

tion itselfbut t he result o fth e intensive physiotherapy provid-

ed i n t he I)ostopei*ati\~eeriod.

The

results of

our

s tudy showed a s ipi t icant ly gri -atcr

improvem ent in functional out come as assessed by t h e

CAI

FJI

in the S P R grou p koniparetl

wi t h children i n

the physiotlicra-

The mean additional improvement of the SPR grou p over

th e pliysiot Iierapy-only group o f 6

1

'% on t h e ClI FlI sc& was

not only statistically sigiiiticaiit b ut isronsitlrretl o b eofmo tl-

e ix te

t o

major

clinical significance

(IIussell

et al. 1989).This

is

reflected by the finding th at , whereas there were

no

improve-

ments

i n

ambulatory s tatus

i n

the children treated with

phys-

iotherapy alone, half of the children in the SPR g oup. ivho

improvetI the ir level ofatnbuIatioii a t

9

months after

SPR.

Th e mean iml)rovenient i n

(iAIFJ1

noted i n th e pliysiother-

apy-only group was 5 . 2 % . and this has to be assessetl i n the

light of expected iml)rovements i n OlIFM as the child

matures. In

a

stu dy of 34 chiltlren with mild o r moderate spas-

tic tliplegic ('P brtween

3

antl 5 yea rs of

age.

and

24

chiltlren

aged 6 yea rs or older: th e

mean

improvement

i n

GAIFJI after

an average fol low-up o f 5 4 months

was

2.8 for the younger

group

ant l

2.3%

for tlic older children (Ru ssell et

al.

1991).

This suggests th at in'tensirc pliysiotheixpy

i l S

typically used

after SPK might by itself'be of

some

benefit for chiltlrrn with

spas tic tliplegia. \Vhether the benefit is more than might be

achieved with more standa rd. less intensive ph ysiotherapy is

not

known.

Seitheris t kno\vn \vlietlieriiiteiisi\.e pliysiotliera-

py is really

necessary

to optimize functioiial outrome after

S P R .

One

other similar. randomized clinicid trial

has

been

reported in abstra ct form recently (D rak eet al. 1995). In tha t

study, SI'R plus physiotherapy

was

compared with physio-

therapy alone in the treatment of chiltlren with spastic

tliplegic

CE

and

a

signifirant improvement i n function was

noted

in

the surgically treated patients compared

wi th

t h e

I'hysiotlierapy-only grou p, using the

GAIFAI as

the primary

outcome measure. However, the I)liysiotlieraj?v-only

g i m p

might have received less physiotherapy t h a n the surgical

patients. Another randomized clinical trial t o rompale

SPR

plus

physiotherapy with physiotherapy alone is

i n

progress

i n

Seattle, Vashington.

In

the present s tu dy there

was

no difference between the

SPK group and the physiotherapy-only group

i n

the o ther

functional assessment measures th at

were

e.qmined as ser-

ontlary outcomes, but i t must be recognized tha t th e s t d y was

not designed to show a difference betueen the two g roups with

respect to any of the secondary outcomes. Furtherm ore, tlie

Peaborly Fine N otor Scale and th e locally tlcvelopetl

evalua-

py-onlygl~oup.

were

not intlepentlent ambidatorsat t l iestart of th J t d y , liatl

tion of scW-carc score both reflect primarily upper-limb funr -

tion. 11hich would not be expected to change much after

lumbo-sacral SI'R. The

lack

of change i n the Physiological

(lost Index might

have

been i*clated n pa rt to technical prob-

Ieins associatrtl with this test

antl

the small numb er ofchildren

in \vhom this assessment \vas (lone. Spa sticity ancl range of

mo\.rnient i n t h e

loiver

limbs improved significantly inore

i n

the SPR group t ha n i n t l ie I)li.ysiotIicra~ y-oiilyroup, i n keep-

ing with th e untlerlying rationiile for doing a

SPR,

and also

coilhistent with the e a i k y non-rantlomized elinical studies.

Significant c ~oinplir;itions ssociated w ith

SPR

ha\v gc.nrr-

ally been

few

(1Qisano et H I 1078.

Peacock

r t al. 1987. Steinbok

e t ul.

l9 )2.

Parket

H I

I993, l IcLaughlinet al.

l ) )-t).

al though

serious postoperative complications iverc ioted in one centet

inasmany

as

15% to 18%ofl'"tieiits(A1)bott 1992.Abbottet

H I

19 )3).

In

the piw ent series there was

one

serious coinpliva-

tion, namcly a postoperativr cpitlural abscess. This \\us lie

only infection t o occur

i n

inoi-t- than 150 rhizotomics wliirh

comprised ourentireseries. Oiieoftliecomiiioiily notedeffects

of SPK. vliirli wibe

a

source of m orbidity, is postoperative

weakness i n lowei*-linibmuscles. Tliis might be of functional

importance when weaknessisprominent in tlie muscles iinpor-

ttiiit for sta ndi ng

and

walking.

such

as

t l ie q uadriceps femoris

antl

tIielii~~abtluctoi.s(;\reiiset

l. 1989).The\vcakne ssis most

niarltetl

iinmcdiately after SPR, iitl th e preo perativ e level of

strength is usually regained

by 1

year after

surgery

(Steinbok

et al. 1995). I n this study, the change i n quadriceps s t rength

from baseline to 9 months was t l ie same for patients treated

with

SI'II

plus physiotherapy as for those iereiving pliysio-

tllel~apy

nly.

~ ~ o s ~ ' l A ~ s l o s

I n this s tudy at the idat ively short assessment t ime of 9

months. we show d t hat

SI'II

followtl by intensiv e physiotlicr-

apy

iml)r o\w l mo tor function ofchiltlren with spas tic tliplegic

Ce

aii

improvemeiit that

was

not simply the result ofintensive

physiotherapy Furtlier stutlics tire needed to confirm these

res11 ts.

. 4 r r t , p / r d f y~ i i t b l i r ~ i / i o i iUh Srp/c,iirlirr

19 K

d

r k i r o i d r i l ~ p i i i rt

I s

\\i.tIiaiik

Ruth Miliicr. \die

liclped

to

tlcsign tIiestuclyTlirstudy

WIS

supportid by

grants froiii tlir British ('olunibia Hca ltli

CIIIVRcsearrh

Foiiiidation.

.-I ri

l ho r v *upp i i i I i i i e i i I s

*Paul

Steinbok.

13Sr.

\I

BHS. R('S('.

Division of Neurosu rgery

LTiiivwsity of British Coluinbia:

Ann 11

Rriiier. BSK, MA. Dcpartiiiiwt of Pliysiotliriqy I3ritisli

Columbia'sCliiltlrcn's Hospitul:

Joliii R I<estle.RSr,

1

D,MSc.FRC'SC',('riit

IL

for

Kvd u i i t i o i i

Sr i r i i cvs .

British Coluriibie

RcwarrIi

Instit ute for('1iiltl

i i i i d

Rinily Hcaltli.

Liiwouver,

BC;

Ricliard Beau cliaiiil). .\I I), FRC'SC'. 1)epartiiiciitofOrthoptlic~s.

Itobcrt

\I'Arinstroiig. idI).

1'1iD.Departiiieiit

of I'cdint

rirs,Brit sli

C'oluiiibia's

Cliiltlrcnk Hospital:

1 DougliisC'orliriine,

11

I),

PR('SC'.

Division of Xeurosurbvry.

Uiiivcisity of British Coluinhia.

*C'orrr s~~i~ , , r t I r~rrro @ r s /

nrtllimr

if

Div iio ii of Petliat ric Seurosurgcry,

British

C'oluiiibiak C 'liiltlrciik H ospit iil,

4480

Oak S t i wt .

Vancouvcbr.

BC'VGH

3V4, ' i i n a d i i .

1

Selcrtive Posterior

Itliizotoriiy

Versus PIiysiotIirrapy PSIrir i6ok rI n l .

183

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