rct- rhizotomy and pt for spastic cp
DESCRIPTION
RCT by Steibok, P. et al.TRANSCRIPT
7/18/2019 RCT- Rhizotomy and PT for spastic CP
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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
7/18/2019 RCT- Rhizotomy and PT for spastic CP
http://slidepdf.com/reader/full/rct-rhizotomy-and-pt-for-spastic-cp 6/7
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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