& SportsPhysical
Therapy
Journalof Orthopaedic
OfficidlPublicdtionof
theOrthopaedicandSportsPhysicalTherapySecrioruo/rhe
AmericanPhysicalTherapyAs.sociarjon
Systematic
Review
of theQualityof
Randomized
Controlled
Trialsfor
Patellofemoral
PainSyndrome
MarroBizzini,PT MS'
Capt.JohnD. Chitds,
PT,MS,MBA,OCS,CSCS,
FAAOMPI2
Sara
R.Piva,PT,MS,OCS,fnnottttpf3
AnthonyDelitto,
PT,PnD,FAPTA+
Study Design:Systematicreview of the literature.
Ob j e ctives:To developa qr adingscaletojudge the qu al i tyof r andom i z edc l i ni c attr i al s( R C T t
and conduct a systematicreview of the publishedRCTSthat assessnonoperativetreatmentsfor
p a te l l o fem or al
pain syndr om e( PFPS)
B a ckg r ound:System atic
r eviewsof the qualityand use ful nesof
s c l i ni c altr i al sal l ow for effi c i ent
syn th e sis
and dissemination
of the liter atur e,
which shoul dfac i l i tatec l i ni c i anseffons
'
to
pr inciplesof evidencebasedpr acticein the c l i ni c aldec i s i on- m ak i ng
i n co rp or ate
pr oc es s .
Methodsand Measures:Using a scalebasedon criieria in the CochraneCollaborationHandbook,
we soughtto criticallyappraisethe methodologyused in RCTsrelatedto the nonoperative
managementof PFPS,synthesizeand interpretour results,and reportour findingsin a
u se rfri endlyfashion.A scaleto assess
qual i tyof tr i al sw as des i gnedand pi l ot
the m ethodolo gi c al
testedfor its conten[and reliability.PublishedRCT5identifiedduring a literaturesearchwere then
selectedand rated by 6 raters.We used predefinedcutoff scoresto identifyspecificweaknesses
in
th e cl i n icalr esear chpr ocessthat need to be im pr ovedi n futur ec l i ni c altr i al s .
Results:The quality scalewe developedwas demonstrated
to be sufficientlyreliableto warrant
i n te rp retation
of the r eviewer s' findings.
The per centage
of tr i al sthat m et a m i ni m um l ev elof
quality for each specificcriterionrangedfrom a low ol 25% Ior the adequacyof the descriptionof
pr ocedur eto a high of 95% for the des c r i pti onand s tandar di z ati on
th e ra n dom ization
of the
Intervention.
C o n cl u sions:
Basedon the r esultsof tr ialsexhibitinga s uffi c i entl ev elof qual i ty ,tr eatm ents
that
were effectivein decreasingpain and improvingfunction In patientswith PFPSwere acupuncture,
q u a d ri ceps
str engthening,
the use of a r esistivebr ace,and the c om bi nati onof ex er c i s es
w i th
patellartaping and biofeedback.The use of soft foot orthoticsin patientswith excessivefoot
p ro n a ti onappear edusefulin decr easing
pain. In additi on,at a s hor t- ter m
fol l ow - up,pati entsw ho
receivedexerciseprogramswere dischargedearlierfrom physicaltherapy Unfortunately,
most
R CT sre viewedcontainedqualitativeflaws that br ingthe v al i di tyof the r es ul tsi nto ques ti on,thus
d i mi n i s hingthe abilityto gener alizethe r esultsto clinic alpr ac ti c e.T hes efl aw sw er e pr i m ar i l yi n
the areasof randomizationprocedures,durationof follow up, control of cointerventions,
a ssu ra nce
of blinding,accountability
and pr operanalys i sof dr opoutsnum
,
berof s ubj ec tsand
,
the
re l e va nceof outcom es.Also, giventhe lim itednum be rof hi gh qual i tyc l i ni c altr i al s ,
fecommendatrons
about supportingor refutingspecifictreatmentapproachesmay be premature
and can only be made with caution../ Orthop SponsPhys Ther.2003;33:4 20.
Key Words: bias, decision making, evidence,grading, methodology
I Physicallherapisl,Departmeil Physical
ot
Therapy,Schulthess
Clinic, Zurich, Switzertand
2 Doctoral candtdate,11.5.Air Force,
Departmentof PhysicatTherapy,Schootof Healthand Rehabtihtiotl Sciences,University of Pittsburgh, Pnsburgh, PA and Physical Therapy Element, Wilford Halt
Medical Center.LacklandAFB, TX.
:t Docloral candidate,
Departmentof Physica!Therapy,Schootof Healh and RehabilitationSciences,
Universnyof Piilsburgh,Pilsburgh, PA.
o Assoctateprolessor
and chairman,Departmentof PhysicalTherapy,Schootof Hcahhand Rehabilitation
Sciences,Universityof Piusburgh,Pnsburgh,PA.
ExempIfrom review by Ihe Universityof PnBburghIRBbasedon the study being a literalurercview The
opintonsor asserlnnsconlainedherein are the pnvaLeviews of the aulhorsand are nol b be construed
as official or as reflecilngthe views of the U.S.Air Forceof Departmentof Defense.
Sendcorrespondence
Io Capt. lohn D. Childs, 59th Medical WingMilford Hail Medicat Center,Physical
Therapy Element/MMKPP,2200 Bergquist Drive, Suite 1, Lacktand AFB, TX 78236-5300. E-mait:
childsid@biofoot.com
atel l ofemoral pai n syn'
drome (P FP S ) i s a com'
mon source of anteri o r
knee pai n i n acti ve i ndi vi dual s.a2:1s4 68 It ac
counts for 257o to 40o/" ol al l knee
probl ems seen i n sports medi ci ne
centers.754 A l though the eti ol ogy
of P FP S i s uncl ear, some have su ggested that ttre pai n and di scomfort i s l i kel y to be the resul t of
abnormal muscul ar and
bi omechani cal factors that al ter
the cl i stri buti on of sheari ng and
compressi ve l orces on the patel l ofernoral j oi nt duri ng norrnal ac
ti vi ty.6l D ye et al l a recentl y sug
gested that the onset of P FP S may
be cl ue to a compl ex pathophysi ,
ol ogi c process that may i ncl ucl e
peri patel l ar synovi l i s, i ncreased
intraosseous pressure, zrnd increasecl i ntraosseous remodel i ng.
B ecause of ttre mul ti factori al
nature of P FP S , many conservativ e
treatment opl i ons have been pro.
posed to treat l hi s condi ti on.
H ow ever, no si ngl e i nterventi on
has been demonstrated to be the
most effective. Consequently, several authors have conducted cri ti cal revi ew s of studi es of tl re
nonoperati ve treal ment of
4868
P FP S .:r'r0
A l though the authors of these reviews offer many
opi ni ons of others' studi es, thei r
judgments are not based on a systematic approach to reviewing the
l i terature. For exampl e, C rossl ey
et allo published a systematic re-
Journal of Orthopaeclic & Sports PhyslcalTherapy
view of physical therapy treatments for PFPS. Sixteen
c l i n i c a l t r ia ls p u b lish e d a s o f Octo b e r 2 0 0 0 w ere selected for review Although the effectiveness of physrc a l t h e r a p y in te r ve n tio n s su ch a s str e n g th e ni ng,
s t r e t c h i n g , b r a cin g , a n d ta p in g wa s d iscu ssed,the
specific criteria used to assessthe methodological
q u a l i t y o f th e se tr ia ls we r e n o t in clu d e d .
A systematic review is a method that many believe
m i n i m i z e s b ia s a n d a llo ws fo r b e tte r clin ica l deci si on
m a k i n g b a se d o n th e e vid e n ce .s Wh e n se veral tri al s
have been conducted that demonstrate efficacy for
m o r e t h a n I tr e a tm e n t in te r ve n tio n , a systemati c rev i e w o f t h e lite r a tu r e h a s b e e n su g g e ste d to provi cl e
t h e c l i n i c i a n with m o r e in fo r m a tio n th a n th e resul ts
o l a s i n g l e stu d y.5 6Di F a b io l.l2 d iscu sse d th e vari ous
w a y s t o g a th e r e vid e n ce fr o m th e lite r a tu r e usi ng tra
c l i t i o n a l , s yste m a tic,a n d m a ske d r e vie ws, a n d metaa n a l y s e s .D i F a b io a lso ca u tio n e d r e a cle r sa bout the
i n t e r p r e t a tio n o f syste m a tic r e vie ws, e r n p h a s i zi ng the
l a c k o f d e fin itio n s a n d th e h ig h d e g r e e o f subj ecti vi ty
w h e n u s i n g th e se te ch n iq u e s. Ja d a d a n d fr is col
l e a g u e s Z 5r e p o r te d th a t B0 % o f p u b lica tio n s i denti I i e d a s s y ste m a tic r e vie ws h a d se r io u s o r e xtensi ve
f l a w s , t h u s co r r o b o r a tin g Di F a b io ' s vie w th at sucl -r
r e v i e w s a r e h ig h ly va r ia b le in th e ir m e th o d o logi cal
risor.
T h e p u r po se o f th is stu d y wa s 2 - [o ld . fir st, w e
s o t r g h t t o de ve lo p a g r a d in g sca le to ju d g e the qual
i 1 . yo l ' r a n d o m ize d clin ica l tr ia ls ( RCT s) ; se condl y, w e
w a r ) t e d t o u se th is sca le to co n d u ct a syste mati c rev i e w t h i l t cr itica lly a p p r a ise s th e m e th o d o lo g ical qual i t y o f t h e p u b lish e cl RCT s th a t a sse ssn o n o p erati ve
t r e a t m e n t s o f PF PS, syn th e size a n d in te r p r e t our res u l t s , a n d r e p o r t o u r fin d in g s in a u se r fr ie n dl y fashion.
METHODS
T o j u d g e th e q u a lity o f th e RCT s, we d e vel oped a
q u a l i t y s c a le b a se d o n th e Co ch r a n e Co lla b o rati on
H a n d b o o k .' T h e sca le in clu d e d fa cto r s th a t have
b e e n d e m on str a te d to e licit b ia s a n d o th e r factors
t h a t m i g h t a ffe ct th e a b ility o f clin icia n s to incorpor a t e t h e r e s u lts in to th e ir clin ica l p r a ctice . T here i s a
g e n e r a l c o n se n su s th a t th e Co ch r a n e Co lla b orati on
g u i d e l i n e s " o ffe r a r e la tive ly h ig h d e g r e e o f ri gor to
s y s t e m a t i c allye xa m in e th e q u a lity o f clin ica l tri al s.
W h i l e t h e r e is fr e q u e n tly little e vid e n ce to support
t h e v a r i o u rswe ig h ts g ive n to co m p o n e n ts o f qual i ty
s c a l e s ,w e be lie ve th a t sca le s sh o u ld id e a lly incl ude
empirically based criteria that have been associated
w i t h b i a s i n clin ica l tr ia ls. T h is is in a cco r d w i th the
v i e w g i v e n in th e Co ch r a n e Co lla b o r a tio n Handbook,
which states that the guidelines for systematic reviews
a r e n o t t o be u se d to d icta te a r b itr a r y sta n d ards, but
r a t h e r t o " h e lp r e vie we r s m a ke g o o d d e cisio ns about
t h e m e t h o d s th e y u se ."e
J C)rthopSportsPhysTher . Volume33 . Numbcr I . January2003
Designof Scale
One meeti ng w as i ni ti al l y conducted among 6 experienced physical therapists with knowledge in factors that lead to bias in clinical trials and who wer.e
fami l i ar w i th determi ni ng the best evi dence upon
which to base treatment strategies for their patients.
D uri ng thi s meeti ng, the group di scussed how to
combine the relevant factors that might influence
the methodol ogi cal qual i ty of a cl i ni cal tri al i nto a
meani ngful scal e. A s an i ni ti al framew ork, the gui delines for systematic reviews proposed by the
C ochrane C ol l aborati on w ere fol l ow ecl .T0B ased or
thi s di scussi on, the group agreed on the i mportance
of 4 mai n cri teri a: (1) popul ati on, (2) i nterventi orrs,
(3) effect si ze, and (4) data presentati on and anal y
sls.
Scoring
System
of Methodological
QualityScale
Twenty-five points were assigned for each of the 4
mai n cri teri a for a total of 100 poi nts. More speci l i c
cri teri a w i thi n each mai n cri teri on w ere then cl evel
oped. D ependi ng on our w ei ghti ng of the cri teri a, a
rnaxi mum of 5 or 10 poi nts per speci fi c cri teri a w ere
gi ven. A l l cri teri a ranged from 0 to 5 or 0 to 10
poi nts, w i th 0 poi nts l or an i nadequate descri pti on
and the maxi mum number of poi nts for an appropri
atel y detai l ed descri pti on and adherence to the pro
specti vel y determi ned rul es w here appl i cabl e. l f the
rater bel i eved that at l east an atternpt hacl been
made to sati sfyany cri teri a, even i f i nadequate, a par
ti al score coul d be assi gned. Thi s l ati tude w i l s provi ded to al l ow the rater freedom to score cri teri a
that w ere parti al l y compl ete and parti al l y cl escri bed.
F-or exampl e, descri pti on of exerci se i nterventi ons
that di d not provi de sufl i ci ent detai l s to faci l i tate
repl i cati on of the study (i e, i nformati on regardi ng
techni que, i ntensi ty, durati on, frequency, etc) coul cl
recei ve parti al credi t. E ach of the speci fi c cri teri a
w ere then further defi ned and w ei ghted consi stentl y
w i th other publ i shed scal es.
Considerations
WithinEachof the 4 Criteria
A bri ef descri pti on of the i tems that contri buted ro
the assi gnment of poi nts w i thi n each of the 4 mai n
cri teri a and the rel ati ve w ei ghts gi ven to the more
speci fi c cri teri a w i thi n each mai n cri teri on i s out
l i ned bel ow .
(25PointsTotat)
Population
Inclusion Criteria (5 Points) The subjects had to be
cl earl y defi ned i n terms of the l ocal i zati on of the
symptoms (anterior part of the knee) and type of
symptoms (pai n duri ng squatti ng, kneel i ng, stai rs,
walking, and sitting with flexed knee) to substantiate
a di agnosi s of P FP S . C ommonl y used di agnosti c sub-
1-
tTl
F
F
rr1
n
tr'l
5
tn
€
stitutions that were also accepted included anterior
k n e e p a in , p a te lla p a in , ch o n d r o m a la cia patel l ae,
a n d p a te llo fe m o r a l ch o n d r a l le sio n s.
Exclusion Criteria (5 Points) T|'e trial had to clearly
define the exclusion criteria for potential subjects.
C o m mo n ly u tilize d e xclu sio n cr ite r ia were previ ous
knee surgeries (tibiofemoral and patellofemoral) and
k n e e in sta b ilitie s ( tib io fe m o r a l a n d p a tel l ofemoral ) .
AdequateNumbcr (10 Poinx) If the null hypothesis
w a s r e je cte d , d iscu ssio n o f p o we r wa s consi dered not
necessary and 5 points were given. However, if the
n u l l hyp o th e sis wa s n o t r e je cte d , th e r a ter searched
f o r t h e a u th o r to co m m e n t o n th e stu dy's pow er. U p
t o a n a d d itio n a l 5 p o in ts we r e g ive n b ased on a scal e
c o n s i d e r in g th e n u m b e r o f su b je cts p e r group: more
t h a n 25 su b je cts = 5 p o in ts; 2 l to 2 5 = 4 poi nts; l 6
t o 2 0 = 3 p o in ts; ll to 1 5 = 2 p o in ts; 6 to 10 = I
p o i n t ; a n cl le ss th a n 5 = 0 p o in ts.
Hontogeneity(5 Points) The baseline characteristics
o f i m po r ta n t p r o g n o stic in d ica to r s ( se x, age, pai n
l e v e l , str e n g th , a n d a ctivity le ve l) h a cl to be si mi l ar
a m o n g th e g r o u p s.
(25 PointsTotal)
Interventions
Standardized and Described (10 Points) The type of
i n t e r ve n lio n u se d in th e stu d y h a d to b e descri bed
e x p l i citly, su ch tlr a t o th e r r e se a r ch e r s woul d be abl e
t o r e plica te tlr e stu d y. [m p o r ta n t cle ta ils of the i nter
v e n t i o n su ch a s typ e , a p p lica tio n te ch n ique, i ntensi ty,
d t r r : r tio n , a n d f' r e q u e n cy o f se ssio n sh a d to be cl earl y
s t a t e d to o b ta in a sco r e o f l0 p o in ts.
Cottlrol and PlaceboAdcqutttc (10 Points) Five points
w e r e a ssig n e d e a ch fo r th e p r e se n ce o l a control
g r o u p a n d a p la ce b o g r o u p .
Coirtlcrvenlions Avoidcd (5 Points) No otlrer interven
t i o n s pa r a lle l to th e n r a in in te r ve n tio n were al l ow ed,
u n l e s s th e r a te r d e te r m in e d th a t th e coi nterventi orrs
w e r e a p p lie d e q u a lly to b o th th e e xp e r imental and
c o n t r ol g r o u p s.
EffectSize(25 PointsTotal)
Rclevant Outconte(10 Poinx) Oulcome measurem e n t s sh o u ld b e e xp licitly d e scr ib e d , symptom and
region specific, and relevant to the research question
and clinical practice. Raters searched for the instru'
ments' reliabilily, validity, and responsiveness. Raters
looked for outcome measures of physical perfor'
m a n c e a n d se lf r e p o r te d m e a su r e s o f p ai n, functi on,
a n d d isa b ility.
Blinded Outcone Assessntent(10 Points) Outcome as
s e s s m e n l d o n e b y a p e r so n m a ske d to group assi gnment must be explicit and sufficiently described.
Follow up Period Adequate (5 PoinX) The following
s c a l e wa s u se d : m o r e th a n 2 4 m o n th s = 5 poi nts; 13
t o 2 3 m o n th s = 4 p o in ts; 7 to 1 2 m o n th s = 3 poi nts;
4 to 6 months = 2 points; 1 to 3 months = I point;
a n d l e ss th a n I m o n th = 0 o o in ts.
6
(25 PointsTotal)
Datapresentation
andAnalysis
Randomization Dcscribed (5 Poinx) The randomiza
ti on procedure had to be expl i ci tl y descri bed. To
avoid excessively penalizing the authors who stated
the w ord "randomi ze" but di d not provi de detai l s of
the randomization procedure used, we allowed parti al credi t.
Dropouts (5 Points) The authors had to clearly descri be the rate of w i thdraw al i n each group. In add i ti on, the reason for subj ects i ni ti al l y enrol l ed i n the
study w ho di d not compl ete the tri al or w ere l ost to
fol l ow up (eg, change of resi dence, j ob change, rre at,
ment i ntol erance, or adverse effect of the i nterventi on) had to be cl earl y stated to al l ow determi nati on
of ri sks associ atedw i th the treatments.
Inlention lo Treat (5 Poins) The data analysis had to
i ncl ude those subj ects w ho w ere noncompl i ant to
treatment or w ere l ost to fol l ow uo.
Proper Statistical Procedures Dcsu-ibed (10 Points) Ttrc
research hypothesi s had to be anal yzed w i tl i the ap
propri ate stati sti cal procedures and provi de a cl ear
descri pti on, i ncl udi ng presentati on of poi nt esti mates
arrd measures of vari abi l i ty.
PilotTesting
of the Scale
To pi l ot test the scal e, tl re same group of 6 expe ri enced physi cal therapi sts i nvol ved i rr the devel opment of' the scal e revi ew ed and score<l 5 publ i shecl
tri al s and then met to cl i scussthe resul ts. The goal of
thi s rneeti ng w ;ts l o assessthe agreentent on the cri .
teri a l i st and the w ei ghts assi gned 10 each i tent. A cldi
ti onal l y, thi s process w as used to cl ari fy any confusi on
regarcl i ng the i nterpretati on of each i tem and to cl e
termi ne i f any si gni fi cant i tems w ere mi ssi ng. The
same 5 tri al s w ere then rescored together duri ng th e
fol l ow i ng meeti ng. D i sagreements betw een revi ew ers
w ere resol ved by consensus under the gui dance of a
thi rd party "rel eree," aruthor A D , w ho w as the seni or
researcher ol 'the group. The i dea w as not to force
the revi ew ers to assi gn the sarne score, but rather to
agree on a common i nterpretati on of each cri teri on .
A range of 2 to 3 poi nts of devi ati on l or each mai n
cri teri on w as consi dered acceptabl e. Tabl e I provi des
a copy of the fi nal scal e that w as used for scori ng the
trials.
LiteratureSearch
B ecause of the know n bi as associ ated w i th desi gn s
other than the RCT,56 we chose to limit the review to
tri al s that at l east w ere purported to al l ocate subj ec ts
randomly to treatment groups. The focus was on
published RCTs in the English peer-reviewed litera
ture. Moher et al3s found no differences between the
qual i ty of reporti ng i n R C Ts publ i shed i n E ngl i sh,
French, German, Ital i an, and S pani sh. Thus there i s
a consensus that to mi ni mi ze ootenti al bi as. al l tri als
J Orthop SportsPhysTher . Volumc33 . NunrberI . January2003
TABLE
1 . S c o r in sca
g leu se dto g r a d etr ia ls
Criteria
Points
Comments
P o p u l a t i o(n25 )
I n c l u s i ocnrite r ia( 5 )
E x c l u s i ocr
n ite r ia( 5 )
A d e q u a tneu m b e r( 1 0 )
(5)
Homogeneity
I n t e r v e n t i o( 2n5 )
S t a n d a r d ize
a nddd e scr ib e(d1 0 )
(10)
C o n t r oal n d p la ce b oa d e q u a te
C o i n t e r v e n tioanvo
s id e d( 5 )
Effectsize(25)
Relevant
outcome(10)
B l i n d e do u tco m ea sse ssm e( n1 t0 )
(5)
F o l l o wu p pe r io da d e q u a te
(25)
D a t ap r e s e nta tio
a n d a n a lysis
R a n d o m i za tio
d enscr r b e(d5 )
Dropoutsaccountedfor (5)
lntentionto treat(5)
P r o p esr t a tistica
p rl o ce d u r e( s1 0 )
Totalscore
s h o u l d b e in clu d e d in syste m a tic r e vie w r e g a rcl l essof
t h e l a n g u a g e in wh ich th e y we r e p u b lish e d .l: ) H ow
e v e r , t h e t r a n sla tio n o f tr ia ls p u b lish e d in la nguages
o t h e r t h a n En g listr wo u ld h a ve b e e n tim e a nd costp r o h i b i t i v e fo r th e p u r p o se s o f th is r e vie w.
W e c o n d ucte d a se a r ch o n th e M EDL INE,
C I N A H L , a n d We b o f Scie n ce d a ta b a se s,a n d the
O o c h r a n e Da ta b a se o f Syste m a tic Re vie ws fo r the pe'
r i o d b e t w e e n 1 9 6 6 a n cl Octo b e r , 2 0 0 0 . T h e fol l ow i ng
k e y w o r d s we r e u tilize d sir - r g u la r lya n d in a ll possi bl e
c o r n b i n a t i or r s: p a te llo fe m o r ill p a in syn clr o m e, patel l a
p a i n , p e r i p ate lla r p a in , r e tr o p a te lla r p a in , p a tel l a,
a n t e r i o r k n e e p a in , kn e e p a in , ch o n d r o m a la ci a patel l a e , c t r o n d ro p a th y, p h ysica l th e r a p y, p h ysio th erapy,
r e t r a b i l i t a t i o n , co n tr o lle d clin ica l tr ia l, a n d r andom,
i z e d c o n t r o lle cl tr ia l. T h e r e fe r e n ce list o r o vided i n 4
('*
p r e v i o u s r e vie ws.ii1 "4 * a n d lh o r e le r e n ce lists i n
t h e i d e n t i f i e d tr ia ls we r e a lso scr e e n e d . Re d undant
t r i a l s w e r e th e n r e m o ve d a n d th e r e m a in in g 20 tri al s
listed as RCTs in the databases were retrieved for
r e v i e w . D e sp ite th e la ct th a t m a n y stu d ie s la c k an
e x p l i c i t r a n d o m iza tio n p r o ce d u r e , we ke p t a l l 20 tri a l s , a n d c l i d n o t a p p ly a m e th o d o lo g ica l filte r to the
R C T s b a s e d o n r a n d o m iza tio n , a s p r o p o se d by
S a c k e t t e t alss fo r 2 r e a so n s: fir st, a sm a ll n u mber of
s t u d i e s w e r e a va ila b le , a n d se co n d , th e r a n d o mi za'
tion criterizr from the scale would account for the
a p p r o p r i a t en e ss o f th e r a n d o m iza tio n p r o ce dure
used.
T o o b t a i n tr ia ls r e la te d to PF PS. th e in clu si on cn
teria for the trial had to provide some framework for
d e t e r m i n i n g th a t th e su b je ct h a d PF PS. Ho wever, bec a u s e t h e i nclu sio n cr ite r ia in so m e tr ia ls we re not
s p e c i f i c e n ou g h to r u le o u t th e p o ssib ility o f compet'
i n g d i a g n o s e s r e la te d to a n te r io r kn e e p a in , some of
the patients in these trials may have had other
s o u r c e s o f a n te r io r kn e e p a in . We o n ly in clu ded tri
I Orthop SportsPhysTher . Volume33 . Nurnber| . J3nqqry2003
als that used nonoperative interventions such as
therapeutic exercises, taping, braces, orthotics, injecti on, and medi cati on.
Scoring
of Trials
The trials were then reviewed by a second group
of physi cal therapi sts, consi sti ng of 6 graduate stu
dents and 2 seasoned facul ty members. D uri ng the
fi rst meeti ng, the arti cl es w ere di stri buted and trai ni ng w as conducted by one of the authors to ensure
that al l revi ew ers understood the components of the
scal e and how to score the vari ous tri al s. A second
meeti ng w as conducted 1 w eek l ater to cl ari fy any
questi ons about the scori ng cri teri a. Thi s meeti ng
served to mi ni mi ze di sagreements or mi sunderstand
i ngs, thus to ensure common i nterpretati on of the
scori ng cri teri a. We pl annecl to resol ve any di sagreement of more than 3 poi nts for a mai n cri teri on be
tw een 2 revi ew ers i n a consensus fashi on. If the di s,
agreement persi sted, a thi rd party "referee" w oul d
be consul ted to assi sti n the resol uti on. H ow ever. be
cause the ranges of the scores w ere w i thi n l i rni ts, ref
eree consul tati on w as not necessary.Fi nal l y, the re
sul ts of the 20 scorecl tri al s w ere l orw arded to one of
the authors. and the resul ts w ere entered i nto a corn,
puteri zed database (S P S S ,V ersi on 10.1, S P S S , l nc.,
C hi cago, l L) for anal ysi s.
A ssessorsw ere not rnasked to the authors. i nsti l rr
ti on, and j ournal of publ i cati on for the tri al urrder
review. Several studies have assessedthe in)portance
of maski ng arti cl es for a qual i ty assessntentof cl i ni c;rl
a2i l A l though
tri al s.2s3740
there i s some evi dence
that fai l ure to rnask l hese fzrctorsresul ts i n l )i gl )er
ancl l ess consi stent scori ng,'" a recent study found no
associ ati on betw een maski ng and unmaski ng w i tl r
respect to factors rel ated to qual i ty assessment."
B oth the l ogi sti cal di ffi cul ty of maski ng and the i n
consi stent magni tude and di recti orr of the effects of
maski ng contri buted to our deci si on not to rnask the
tri al s.
Interrater
Reliability
of the Scale
The i ntracl ass correl ati on coefl i ci ent (l C C 1,,) for
each component of the scal e and for the total score
of the tri al w as cal cul ated accordi ng to the method
descri bed by S hrout and Fl ei ss.(j oForrnul a l ,l w as
used because each trial reviewed was rated once by a
di fferent set of raters.(i oIn thi s case, 6 out of 8 revi ew ersj udged each tri al and the combi nati on of rat
ers varied for each trial.
ldentification
of Areasof lmprovement
To i denti fy w eaknessesi n the methodol ogy used i n
the RCTs in the treatment of PFPS, it was necessary
to establ i sh a mi ni mum l evel of oual i tv for each of
:
trl
F
n
m
F
lTl
:
€
the 14 criteria in the quality scale. Minimum quality
was operationally defined as a trial scoring at least
half of the maximum possible score for the criterion
under review For example, if a specific criterion was
a s s i g n e d a m a xim u m sco r e o f 1 0 p o in ts, tri al s that
achieved a score of at least 5 points for this item
w e r e co n sid e r e d to m e e t a m in im u m level of qual i ty.
T a b l e 2 d e p icts wh e th e r th e m in im u m l evel of qual ity was satisfied for each criterion across all of the
t r i a l s r e vie we d . T h e n , fo r e a ch o f th e 14 cri teri a, w e
c a l c u la te d th e p e r ce n ta g e o f th e tr ia ls (number of
t r i a l s o u t o f th e 2 0 tr ia ls) th a t m e t th e mi ni mum
l e v e l o f q u a lity. A ca lcu la tio n o f th e p e rcentage of
t r i a l s th a t m e t th is cu to ff wa s u se d to identi l y speci fi c
a r e a s o f th e clin ica l r e se a r ch p r o ce ss lh at needed
i m p r o ve m e n t. We d e lin e d Ih a t if 7 0 o /oor l ess of the
t r i a l s clid n o t m e e t th e m in in r u m le ve l of qual i ty i n a
s p e c i fic cr ite r io n , th a t cr ite r io n r e fle cle d a probl ent,
a t i c a r e a th a t n e e d e d to b e m o r e a d e o uatel v ad
d r e s s e d in fr r tu r e tr i;r ls.
T h e cu to ff va lu e se le cte d to d e fin e a mi ni murn
l e v e l o f q u a lity a n d th e d e fin itio n o f a r eas that
n e e c l ed im p r o ve m e n t b a se d o n th e p e r c entage of
t r i a l s th a l m e t th e m in im u m le ve l o l' q u al i ty are ad
m i t t e clly so m e wh a t a r b itr a r y. Ho we ve r , w e chose a
m i n i mu m le ve l o f q u a lity o f h a lf o f th e maxi mum
p o i n t s p o ssib le to p r o te ct a g a in st th e p ossi bi l i ty of
b e i n g u n r e a so n a b ly cr itica l in th e r e vie w. Moreover,
b a s e d o n o u r ju d g r n e n t, th is n iin im u m l evel seemed
t o c l i ffe r e n tia te th o se tr ia ls with su flicie nt qual i ty to
p r o v i c le va lid r e su lts with a d e q u a te g e n eral i zabi l i ty. It
i s e n t ir e ly p o ssib le th a t a d iffe r e n t se t of revi ew ers
m a y h a ve se le cte d d iffe r e n t cu lo ff sco r es.
RESULTS
The ICCs for each criterion in the scale and the
total score of the methodological quality of the trials
are reported in Table 3. The ICCs for the items
within each of the 4 main criteria ranged from 0.64
for the i nterventi on's standardi zati on and descri ption
to 0.99 for the i tem rel ated to the bl i ndi ng of outcome assessors.The ICC for the total oualitv score
w as 0.97.
Descriptive statistics (mean and standard devia
ti on) of each tri al w i th respect to the i ndi vi dual cri teri on score and total methodol ogi cal qual i ty score ca n
be seen i n Tabl e 4. The total methodol ogi cal qual i t y
scores ranged from a l ow score of 19 to a hi gh sco re
of 82.
Tabl e 5 i l l ustrates the rel ati ve scores of each tri al
and the descri pti on of i nterventi ons assessedi n eac h
of the R C TS .The di spl ay of the scores w as di vi cl ecl
i nto quarti l es to faci l i tate vi sual i z:rti on of the di stri bu
ti on of the scores. Tw o tri al s scored i n a range of 0
to 24 poi nts, 5 scored betw een 25 Io 49,8 scorecl
betw een 50 to 74, and 5 scored betw een 75 to 100.
Whether l l re tri al detected a si gni fi cant di fference
betw een i nterventi ons and w hat i nterventi orr w as
show n to be superi or i s al so noted i n Tabl e 5. To
faci l i tate the di scussi on of the resul ts of the revi ew .
w e cl assi fi ed the i nterventi ons i nl o 7 groups, b:rsec l
on the pri mary goal of the i nterventi on. We cl assi
fi ed separatel y the studi es i n w hi ch more than I i n
tervenl i on w as tested (eg, an exerci se progral tr vers us
educati on, and versus educati on w i th tapi ng). The
groups are as fol l ow s: (l ) orthoti cs (i ncl udi ng fbot
T A B L E2. Descr iptivestatisticsfor each tr ial and per c entageof tr i al s m eeti ng the m i ni m um l ev el of qual i ty for eac h ar ea. Yes i ndi c atest h e
th e l a st column.
Criteria
P o p u la tio(n2 5 )
I n c l usiocr
n ite r ia( 5 )
E x c l u siocr
n ite r ia( 5 )
A d e q u a te
n u m b e r( 1 0 )
(5)
H o mo g e n e ity
I n t e r ve n tio( 2n5 )
S t a n d a r d ize
an
d dd e scr ib e(d1 0 )
Controland placeboadequate('10)
C o i nte r ve n tioanvo
s id e d( 5 )
Effecrsize(25)
R e l eva notu tco m e( 1 0 )
B l i n de do u tco m ea sse ssm e( n1 t0 )
(5J
F o l l ow- u p e r io da d e q u a te
(25)
D a t ap r e se n ta tio
a n da n a lysis
R a n d o m iza tio
n scr ib e(d5 )
de
Dropoutsaccountedfor (5)
Intentionto treat(5)
(10)
Properstatistical
procedures
RogviAntich2 Fulkersonls FinestonelT Miller3s Kowall32 Eburnel5 Rowlandss3 Roush52 Hansensl
no
no
no
no
no
no
yes
no
yes
no
no
no
yes
yes
no
no
yes
no
no
yes
yes
yes
yes
yes
yes
yes
no
yes
no
no
yes
yes
yes
no
no
yes
yes
no
yes
no
no
no
no
no
no
no
no
no
no
no
no
no
no
yes
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
no
yes
no
yes
yes
yes
yes
no
no
t'-
yes
yes
no
no
yes
yes
no
yes
yes
yes
no
yes
yes
no
no
no
no
no
no
no
yes
no
no
yes
no
yes
no
no
no
yes
no
yes
no
no
no
no
no
yes
J Orthop Sports Phys Ther . Volurne 33 . Number I . January 2003
o r t h o s e s , p a te lla r b r a ce s, e la stic sle e ve s,a n d patel l ar
taping), (2) manual therapy, (3) modalities, (4)
medications, (5) acupuncture, (6) strength training
m e t h o d s , a n d ( 7 ) co m b in e d in te r ve n tio n s. T he theoretical rationale and the results of each study will be
discussed with respect to the treatment category to
w h i c h t h e tr ia l wa s a ssig n e d .
The percentage of trials that met the minimum
level of quality for each specific criterion based on
this definition ranged from a low of Z5%ofor the ade q u a c y o f th e d e scr ip tio n o f th e r a n d o m iza tion proc e d u r e t o a h ig h o f 9 5 u %fo r th e d e scr ip tio n and
s t a n d a r d i z a tio n o f th e in te r ve n tio n ( T a b le 2 ).
S e v e r a l a r e a s in clu d e d in o u r q u a lity sca le w ere
c o n s i s t e n t l y sco r e d h ig h b y m o st o f th e tr ia ls , sug
g e s t i n g a g o o d u n d e r sta n d in g o f th e se cr ite r ia by the
r e s e a r c h e r s.F ive o u t o f th e 1 4 a r e a s sco r e d w el l , de,
fined as greater than 70o/oof the trials meeting the
m i n i m u m l e ve l o f q u a lity. T h e se 5 cr ite r ia in c l ude:
( i ) s t a n d a r d iza tio n a n d d e scr ip tio n o f in te r venti on.
( 2 ) a d e q u ate co n tr o l a n d p la ce b o , ( 3 ) cle scri pti on of
i n c l u s i o n c rite r ia , ( 4 ) d e scr ip tio n o l e xclu sion cri te
r i a , a n d ( 5 ) p r o p e r sta tistica l p r o ce d u r e s. T a bl e 2
i n c l u d e s t h e sp e cific p e r ce n ta g e fo r e a ch o f these
i t e m s . B e c au se th e se ite m s we r e co n siste n tly scoreri
f r i g h b y t h e r e vie we r s, th e se co m p o n e n ts o f t he cl i n
i c a l r e s e a r ch p r o ce ss will n o t b e cliscu sse dfu rther.
N i n e o t r t o f 1 4 sp e cific a r e a s o l' th e sca le di d not
s c o r e w e l l , su g g e stin g a p o o r u n d e r sta n d in g of these
c r i t e r i a b y tlr e r e se a r ch e r s.T lr e y in clu d e th e fol l ow i n g . ( l ) a c le q u a te d e scr ip tio n o f r a n d o m iza tion, (2)
a d e q u a t e f ollo w u p , ( 3 ) su fficie n t co n tr o l o f
c o i n t e r v e n tio n s, ( 4 ) a ssu r a n ce o f b lin d in g , ( 5) con
sideration of an intention-to treat analysis (ITT), (6)
adequate number of subjects, (7) inclusion of relevant outcomes, (B) proper accounting for withdraw,
al s and dropouts, and (9) homogenei ty of groups at
basel i ne.
DISCUSSION
Reliability
of theScale
The IC C ranges from 0 to 1, w i th hi gher val ues
representi ng better rel i abi l i ty. P ortney and Watki nsaT
suggest that IC C s above 0.75 represent good rel i abi l i ty, IC C s from 0.75 to 0.5 represent moderate rel i abi l
i ty, and those bel ow 0.5 i ndi cate poor rel i abi l i ty. In
thi s study, the consi stency of rati ng each cri teri on
and rati ng the total score usi ng the qual i tati ve scal e
w as consi dered acceptabl e. Wi th excepti on of 3 cri te,
ri a that demonstrated moderate rel i abi l i ty (i ncl usi on
cri teri a, homogenei ty of groups, and descri pti on of
i nterventi ons), al l other cri teri a demonstrated goocl
rel i abi l i ty. The total score of qual i ty of the tri al s
seems [o represent consi stency of rati ng among al l
cri teri a. A l though w e recogni ze that the content of
any gradi ng scal e i s determi ned by the consensus of
i ndi vi cl ual s w ho devel opecl i t, w e bel i eve that the to,
tal scores offer some val uabl e i nformati on as to the
methodol ogi cal qual i ty of the tri al s, based on ttre
good rel i abi l i ty demonstrated across the r:rti ngs.
:
m
F
F
m
Summary
of the Trials
The remai ni ng di scussi on provi des a surnmary ol
the resul ts of the systemati c revi ew w i th each tri al
F
rn
:
mtn tmu m l e vel ot qualr ty was m et and no indicatesthat i t w as not; per c entagesof tr i al s m eeti ng m i ni m um l ev el of qual i ty ar e denoted i n
Engr6 Thomee6T Suter6a Harrison20
yes
yes
yes
yes
yes
yes
no
yes
yes
yes
no
no
no
no
Timm6s WitvrouwTa
yes
yes
yes
yes
yes
yes
yes
yes
no
no
yes
yes
no
no
no
no
no
no
no
no
no
no
yes
no
yes
yes
yes
yes
Raatikainens0 KannuszT Clark8
Kannus2s Jensen26
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
no
yes
yes
yes
yes
90%
B0%
60%
65%
yes
yes
yes
yes
yes
no
no
yes
yes
no
yes
95%
B 0%
45%
yes
yes
yes
yes
no
yes
yes
yes
yes
yes
yes
no
yes
no
yes
no
yes
no
yes
yes
yes
yes
yes
yes
no
yes
yes
yes
yes
yes
no
no
% Meeting
Mi ni mum
Qual i ty
I Ortlrop Sports Phys Ther . Volume 33 . Number I . January 2003
J"'
yes
60%
35%
30%
no
yes
yes
25%
10%
50%
15%
m
€
(lCC$for
TABLE3: Summaryof intraclass
correlation
coefficients
scalecriteriaand totalscore
Cr ite r ia
a
IC C(Formul 1,1)
P o p ul a tio n
I n clu siocr
n ite r ia
E x c lu siocr
n ite r ia
A d eq u a te
number
Homogeneity
Intervention
S t an d a r d ize
d d d e scr ib e d
an
C o n tr oal n d p la ce b oa d e q u a te
C o in te r ve n tioanvo
s id e d
Effectsize
Relevant
outcome
B l i n d e do u tco m ea sse ssm e n t
F o l lo w- u p e flo da d e q u a te
D a t apr e se n ta tio
a n d a n a lysis
R a n d o m iza tio
n scr ib e d
de
Dropoutsaccountedfor
lntentionto treat
p rl o ce d u r e s
P r o p esta
r tistica
Totalscore
0.66
0.89
0.91
0.74
0.64
0.95
087
087
099
092
0.93
0.96
095
091
0.97
b e i n g d iscu sse d with in th e tr e a tm e n t g roup 1o w hi cl r
t h e t ria l wa s a ssig n e d ( b a se d o r r th e p r imary goal of
t h e i nte r ve n tio n ) . T h e th e o r e tica l r a tional e for each
i n t e r v e n tio n is d iscu sse d to p r o vid e a context that
m i g h t e xp la in wh y th e in ve stig a to r s in each cl i ni cal
t r i a l se le cte d th e p a r ticu la r tr e a tm e n t or cornbi nati on
o [ t r e a tm e n ts in th e ir slu d y. In a d d itio n, the i tems i n
t h e sca le in wh ich tlr e m in im r :m le ve l of qual i ty w as
m e t o r w.r s n o t r n e t fb r e a ch tr ia l is r e Dortecl .
Orthoticlnterventions
O r th o lic in te r ve n tio n s su ch a s lo o t orthoses, patel l a r b r a ce s, e la slic sle e ve s,a n d p a le lla r tapi ng w ere
included in the same intervention group because an
orthosis is defined as any external appliance worn to
restri ct or to enhance moti on.44 The use of foot
orthotics for PF-PSis based on the assumption that
excessive foot pronation during stance phase would
cause abnormal ti bi al i nternal rotati on that conse,
quentl y w oul d di srupt the normal tracki ng of the
patel l a i nsi cl e the trochl ear groove.l 3 l tj 30 Therefore ,
the foot orthotic is believed to modify foot and leg
position during stance phase of gait, potentially restori ng normal patel l ar tracki ng.
E ng et al rG conducted a R C T assessi ngthe effi cac y
of soft foot orthoti cs i n a group of adol escent femal es exhi bi ti ng excessi vefoot pronati on, w hi ch w as
defi ned as cal caneal varus or forefoot varus greater
than 6". P ati ents w ho compl eted 16 sessi onsof a
physi cal therapy program consi sti ng of exerci ses an c l
the w eari ng of soft fbot orthoti cs w ere demonstrated
to have si gni fi cant reducl i ons i n pai n compared to a
control group w ho compl etecl the same physi cal
therapy program, except they di d not recei ve the s oft
foot orthoti cs. Therefore, i t seems that there i s son re
evi dence for usi ng thi s i nterventi on i n femal e acl o l es
cents w fro exhi bi t excessi vefoot pronati on. Thi s trial
w as assi gned a score of 6l poi nts (Tabl e 5). Thi s tri al
di d not meet the mi ni mum l evel of qual i ty l br th<:
fol l ow i ng i tems i n the scal e: coi nterventi ons avoi clec l ,
rel evant outcome, bl i ncl ed outcome assessrnent.
fbl l ow up peri od adequate, ancl randonri zati on cl e
scri bed (Tabl e 2).
P atel l ar braces w ere i ni ti al l y suggesteclas an i nl .er
venti on purported to appl y a sustai ned rnecl i al l ydi s
pl aci ng for( e l o tl re l ateral horder ol tl re parel l r.a: '
The theoreti cal rati onal e of patel l ar braci ng i s to i m -
T A B L E 4. Descr iptivestatistics( mean t standar d dev i ati on) for the r ev i ew er s ' s c or es on eac h c r i ter j on i n the qual i tv s c al e for al l of t h e
Criteria
Antich2
F ul k er s onts F i nes tonel T M i l l er 3s
P o p u l a tio(n2 5 )
I n c lu sioCr
n ite r ia( 5 )
03t 0. 5 2 . 0 r 0 . 9 2 5 r 0 . 8
E x clu sioCr
n ite r ia( 5 )
00t 0. 0 0 . 4 r 0 . 7 1 0 t 0 B
A d e q u a te
Nu m b e r( 1 0 )
2. 1x 0.5 6 . 0 r 0 . 9 3 5 t 0 . 5
(5)
H o mo g e n e ity
0. 0r 0.0 1 . 8 r '10 1 5 t 0 . 5
I n t e r ve n tio( 2n5 )
S t a nd a r d ize
d d De scr ib e(d1 0 )
an
6 .0 r 1 .5 8 . 5r 1 . 1 7 . 0t 0 . 9
( 1 0 ) 5 .3r 0 .5 0 . 0 t 0 0
C o ntr oal n d Pla ce b Ad
o e q u a te
5.0r0.0
C o i n te r ve n tioAvo
n s id e d( 5 )
1 .0r 0 .9 0 . 4 t 0 . 5 4 6 t 0 . 5
tffectSize(25)
' 1 .7t 1 .0 3 . 0t 1 . 3 3 . 0r 1 . 1
Relevant
Outcome(10)
B l i nd e dOu tco m eAsse ssm e(n1t0 )
0 .0 + 0 .0 0 . 0 t 0 . 0 0 0 r 0 . 0
(5)
F o l l o w- u Pe
p r io dAd e q u a te
0 .7 t 1 .0 0 3 t 0 . 5
19t0.4
(25)
D a t aPr e se n ta tio
a n dAn a lysis
R a nd o m iza tio
De
n scr ib e(d5 )
1 .0t 0 .9 0 . 6r 0 . 5 0 . 1r 0 . 4
DropoutsAccountedFor (5)
0 3 r 0 .5
0 . 0r 0 . 0 0 . 3t 0 . 7
IntentionTo Treat(5)
0 .0 t 0 .0 0 . 0r 0 . 0 0 . 0t 0 . 0
('10)
ProperStatistical
Procedures
0 0 t0 .0
0 . 9r '1 . 0 1 . 0r 1 . 1
TotalScore(100)
1 9 .0t 1 8 2 38 r 3 . 5 3 '1 .r4 3 . 2
l0
4 . 0 r '10
4.7r05
2.9t07
2 . 1t 0 9
Kowall32
Eburner5 Rowlands53
Roush52
45t0.5
0.3r05
2 6 r 0.5
4.5r0.5
40+09
2.1 t0.5
6.7 t 0.5
33r0.5
4.4r0.5
49r0.4
2.9t 0.1
0.7r1.0
3.1r1 1
4.'l t0 9
4.6t 0 .8
2.3r05
5.3 t '1.4 8.7 r 1.1
43t1.0
5.1r0.4
1.0r0.9
5.0t00
9.1t 0 .9
50t00
1.1r1.1
4 . 9t 0 . 9 5.4 r 0.7
5 . 3 t 0 5 5.0r0.0
1 . 4 r 0 . 8 0.3r05
3 . 3t '1. 0
0.0t0.0
13t0.5
5.4t 0.7 0.3 r 0.5
0.0t0.0 10.0r0.0
0.5t05
0.3t0.5
5.9t 0.9 4.1 t 0 .9
100t00
0.0t00
16r05
06t05
0 . 3r 0 . 5 44t0.1
1.3r05
14t0.5
0.6r0.5
0 . 0r 0 . 0 4.5 t 0.5 2.1 x 0.5 0.0 t 0.0 4.7t 0 .5
'1
.
0
4 . 0r
44t0.9
0.0t00
0.0t0.0
0.0r0.0
4 . 0t 1 . 0 5.9t10
5.7t10
8.6r10
39t1.3
3 8 . .r13 . 9 41.5t29 41.1 l - 10 48.1t2.0 543r4.3
J Orthop Sports Phys Ther . Volunre 33 . Nurnber | . J3nuary 2003
prove tracking of the patella in the trochlear groove,
thus reducing the pain believed to be associated with
p a t e l l a r m a la lig n m e n t. T wo tr ia lslT 3 8 in o u r revi ew
incorporated a patellar brace for the purpose of imp r o v i n g p a in . F in e sto n e e t a ll7 u se d a sa m p le of i ndi viduals diagnosed as having overuse patellofemoral
pain to compare the efficacy of an elastic knee sleeve
t h a t h a s a silico n e p a te lla r r in g with a sim p le el asti c
s l e e v e w i t h a co n tr o l g r o u p th a t r e ce ive d n o treatm e n t . T h e y r e p o r te d n o d iffe r e n ce in p a in r educti on
b e t w e e n t h e g r o u p s a n d r e p o r te d th a t we a r ing the
s l e e v e w i t h a silico n e r in g r e su lte cl in sig n ificantl y
m o r e s k i n ab r a sio n . M ille r e t a l:J8co m p a r e d w hat
t h e y r e f e r r ed to a s a "d yn a m ic p a te lla r b r a ce" versus
a k n e e s t r a p ve r slls a n o b r a ce co n d itio n . T h ey founcl
n o s i g n i f i c a n t d iffe r e n ce in p a in b e twe e n th e groups
t h r o u g h o u t th e stu d y. T h e stu d ie s b y F in e slone et
a l l T a n d M i lle r e t a l:1 8we r e a ssig n e d sco r e s o f 31 and
3 8 p o i n t s , re sp e ctive ly ( T a b le 5 ) . Bo lh o f th e se tri al s
d i d n o t m e e t th e m in ir n u m le ve l o f q u a lity for ad
e q u a t e n u mb e r o f su b je cts, h o m o g e n e ity o f groups,
t r s e o f ' r e l e va n t o u lco m e , b lin d e d o u tco m e , bl i nded
o u t c o r n e a sse ssm e n t,fo llo w- u p p e r io cl a d e q u ate, ran
d o m i z a t i o n d e scr ib e cl, a cco u n tin g fo r d r o p o u ts, and
p r o p e r s t a tistica l p r o ce clu r e s. F u r th e r m o r e , the
F i n e s t o n e e t a l" tr ia l < iid n o t r n e e t th e m in imum
I e v e l o I q u ality fo r th e e xclu sio n cr ite r ia a n d i nten'
t i o n t o t r e a t, wh e r e a s th e M ille r e t a liJ8stu d y di d not
r l l e e t t h e min im u m le ve l o f q u a lity fo r sta n d arcl i zat i o n a n d d e scr ip tio n o f in te r ve n tio n a n d a vo i dance
o f c o i n t e r v e n tio n ( T a b le 2 ) . Ba se d o r r th e r e lati vel y
l o w q u a l i t y sco r e s o f th e se stu d ie s, th e r e d o e s not
a p p e a r t o b e a d e q u a te e vid e n ce to su p p o r t or refute
t h e u s e o f pa te lla r b r a cin g to im p r o ve p a te llar pai n
i n t l l e r n a r )a g e r n e n t o f PF PS.
Timm6s conducted a study in which he compared
a group that used the Protonics brace (Inverse Tech,
nol ogy C orporati on, Li ncol n, N E ) duri ng dai l y acti vi
ties against a control group that received no treatment. The brace was designed to provide progressive
resi stanceto knee moti on i n the sagi ttal pl ane, w i th
the rati onal e that a hi gh vol ume of submaxi mal con
centri c contracti ons of the quadri ceps and hamstri ng
muscl es may perhaps faci l i tate patel l ar al i gnment and
reduce abnormal patel l ar congruence and pai n.
They reported that pati ents i n the experi mental
group had si gni fi cant reducti on i n pai n and i mprove,
ment i n functi on compared to the control group.
B ased on these resul ts, there seerns to be some evi dence that thi s resi sti ve brace may reduce pai n and
i mprove functi on. Thi s study w as assi gned a score of
72 poi nrs (Tabl e 5). Thi s tri al di d not meel the mi ni ,
mum l evel of qual i ty for the fol l ow i ng i tems i n the
scal e: bl i nded outcome assessment,fol l ow up peri ocl
adequate, and randomi zati on cl escri becl (Tabl e 2).
P atel l ar tapi ng i s suggested to correcrt the posi ti on
of ttre patel l a to promote al i gnment, reduce pai n,
and reducej oi nt reacti orr forces.l l l l (i A recent revi ew
of nonrandomi zed studi es of' patel l ar tapi ng con,
cl ucl ed that, al though there i s some evi dence to support the appl i cati on of patel l ar tapi nf{ to produce
i mrnedi ate reducti on i n pai n cl uri ng provocati ve
tasks, there i s i nsuffi ci errt evi dence to confi rm any
carr.yover i n pai n recl ucti on or any other proposed
efl ect.' '
We found onl y I R C T tl rat i sol ated tl re effect o[
patel l ar tapi ng as the treatment bei ng stucl i ecl .
K ow al l et al :12found no si gni fi cant di ff'erences at a
I rnonth fol l ow -up betw een a physi cal therapy program over B sessi onsthat i ncorporated stretchi ng
=
tr'l
n
c
n
m
F
m
:
m
€
t r i a l si n c l u d edin th e r e vie w.
RogviHansensr
4 . 0r 0 . 0
33r0.5
30r00
5 0 r 0.0
Engtu
Thomee6T
Suter6a
4 .8 r 0 .5
4 .3 r 0 9
6 8 t0 9
4 .6 r 0 .7
4 .9 r 0 4
4 9 t0 4
4 7 t0 5
4 .3 r 1 .0
50r 0. 0
50r 00
100t 00
44r 0. B
Ha r rison2o
WitRaatiTimm6e vrouwT4 kainen5o Kannus2T Clark8
50t 00 50r00
50t 00 50t0.0
100r 00 10.0t 0.0
4. 4t 0. 8 4.4t0.8
49r0.4
4.4r0.8
10.0r 0.0
40t08
4.2+1.0
4.0r0.9
12t1.0
4.3r 0.5
4.9t0.4
47t05
81t1.5
4 0 r 1.0
45i 08
4B :0.5
8.3 r 1.2
4.8 r 0.5
Kannuszs
Jensen26
45-08
50-00
49-04
33-09
7.7 t 'l 1 10.0t 0.0
1.1t 0.9 4.5r 0.8
9 . 3t ' 1 . 0 9 .3 r 1 .0 9 .9t 0 .4 100r 00 10. 0t 0. 0 10.0r 0.0 8.6 r 1.4 7.5r 0.8 9.1 t 1.2 1.B x1.2 9.1 t09
100t00
5 0 t0 .0
0 .3 t0 5
50r 0. 0 5. 0r 0. 0 5.0 r 0.0 5.0r 0.0 9.0t09 9.0r0.8 4.8r0.5 93r05
1 0 t1 0
03r05
05r05
36t 05 36t 05 36t0.5 4.0r0.8 25r0.5 40t08
13i 0.9
06.05
B 9t12
5.6t1.2
43.09
4 . 0 r 0 . 9 4 .4 t0 .9 9 7 t0 .5
7. 3t 1. 0 7. 3t 1. 0 73t10
1 0 . 0 r 0 . 0 0 .0 t0 0
0 0 t0 .0
0. 0t 0. 0 0. 0t 00 0,0t00
2 . 0r 0 . 0 '1 .5t 0 .5 4 .4t 0 .5 1. 4t 0. 5 1. 4r 0. 5 14t0.5
7.8t 0.5
9.8t 0.7
4.0t 0.0
07t0.5
00t00
0 0 t 0.0
60+0.9
5 1. 1 + 1 4
0 6 t0 .5
4 .6 t0 .5
4 .8 r 0 .5
9 6 t0 7
6 0.6t 4 .5
4 6 t0 5
5 .0 r 0 .0
5 .0t 0 .0
100100
6 8 .6t2 .2
B 6t0.8
73t1.0
0,1 t0.4 10.0r0.0
19t0.4
4.3r0.5
10t 08 10t 08 '1.0t 0.8 5.0r 0.0 1.0r 0.6
5. 0r 0. 0 5. 0r 0. 0 5.0 r 0.0 4.7t 0.8 4.7t 0.5
50t 0. 0 5. 0r 0. 0 5.0r 0.0 4.4r 0.8 00t00
9 3 t 1. 0 9. 3t 1. 0 9.3 t '1.0 9.0r 1.0 9.3t 0.8
12. 0x 2. 2 12. 0t 2. 2 12.0t2.2 14.6t2.5 75.3r4.1
J Orthop Sports Phys Ther . Volume 33 . Number I . January 2003
90+10
4.6t05
37+05
0.4 t 0.5
4.9 r 0.4
1.0t0.8
8.9 t 1.1
763t3.5
B 4 t 0.9 8.7 t 1.0
9.4 t 0.9 10.0t 0.0
2.9 t 0.8 5.0 t 0.0
5.0 t 0.0
41t1.0
4.8t0.5
95r0.9
800r 2.7
4.9 r 0.4 0.5 t 0 5
49t0.4
5.0t0.0
0.0r0.0 46r0.5
93+1.0 100'00
80.4t 30 826r 3.6
TABLE5. Summaryof the meantotalscoresbetweenthe reviewers
for eachtrial in the studyand the resultsdisplayedrelativeto the intervention.When a significant
difference
was detectedbetweentreatment
groups,the horizontalbar appearsas a solid bar and is placednext
to the intervention
shownto be moreeffective.
When no differences
werefound,the horizontalbar appearsas a stripedbar and is placed
i n t h e c e n te o
r f th e ce ll.Sco r e( d ivid e din q u a r til es),
e
w i th thetotalpossi blscore
from0 to 100 poi nts(0 meani ngpoorquati tyand 100
m e a n in h
g ig hq u a lity) .
MethodologicQualityScores
Trial
Antich2
F u lke r so n ls
Interventions
0-24 25-49 50-74 7s-100
lce
Ph o n o p h o r e sis
lontophoresis
Ultrasound/icocontrast
Nonsteroidalanti-inflammatory
A (diflunisal)
: Nonsteroidalanti-inflammatory
B (naproxen)
F in e sto n e r T
Elasticsleeve(siliconring)
Simpleelasticsleeve
No sle e ve
Milled8
Palumbobrace
Cho strap
No brace
Kowall32
Physicaltherapy(PT) programand patellartaping
PT program
Eb u r n e r 5
lsometricquadricepsexerciseand functionalre-education
. M cCo n n e ll' rse g imen
Rowlandss3
Patella mobilization
Detuned ultrasound
Roushs2
Home program
PT program
Home program("vastusmedialisobliquespecial")
RogviHa nsonsl
Low-level laser
Sham laser
Eng "
Physicaltherapyprogram/footorthotics
Physicaltherapyprogram
Thom ee6/
lsometricquadricepsexercise
Eccentricquadricepsexercise
Suters
Sa cr o ilr aio
c in tm a ni pul ati on
Sacroiliacy'lower
back "assessment"
Harrison2o
Home str€ngth/strelchingprogram
Programmonitoredby PT
ComprehensivePT program
Tim m 6e
Exercisewilh "resistedbrac€"
No treatment
WitvrouwTa
Open kineticchain exercise
Closed kineticchain exercise
polysulfate
Raatikainenso
' I njectionsg lycoaminoglycan
Plac€boinjection
Kan nus27
polysulfate/quadrics
ps
I njectionglycoaminoglycan
ex€rcise
Placeboinjection/quadriceps
exercise
Quadricepsexorcise
Clarkg
Exercise/taping/ed
ucation
Exercise/ed
ucation
Ta ping/education
Education
Ka n n u s2 E
polysulfate/quadriceps
Injectionglycoaminoglycan
exercise
Placeboinjection/quadriceps
exercise
Ouadricepsexercise
Jenson26
Acupuncture
No tr€atm6nl
J Orthop Sports Phys Ther . Volume 33 . Number I . January 2003
a n d i s o m etr ic, iso to n ic, a n d iso kin e tic q u a d ri ceps
strengthening exercises versus the same program
plus patellar taping applied during the exercises.
T h i s t r i a l w a s a ssig n e d a sco r e o f 4 8 p o in ts (Tabl e 5).
T h e s t u d y d id n o t m e e t th e m in im u m le ve l of qual i ty
for the following items in the scale: description of
e x c l u s i o n c r ite r ia , a d e q u a cy o f n u m b e r o f p arti ci
p a n t s , a v o id a n ce o f co in te r ve n tio n s, b lin d e d outcome
a s s e s s m e n t,a n d fo llo wu p p e r io d a d e q u a te (Tabl e 2).
B a s e d o n th e r e su lts o f th is stu d y a n d in lig ht of i ts
q u a l i t y s c o r e , th e u se fu ln e ss o f p a te lla r ta p ing i n the
m a n a g e m e n t o f PF PS is n o t cle a r .
ManualTherapy
M a n u a l th e r a p y fo r th e tr e a tm e n t o f PF PS has
b e e n u s e c l in I RCT in th e lo r m o f m a n u a l stretcl )i n g o f t h e la te r a l p a te lla r str u ctu r e s a n d in another
R C T a s m an ip u la tio n d ir e cte d to th e sa cr o il i ac.i oi nt
( S l . f ) . S t u d ie s h a ve su g g e ste clth a t p a tie n ts wi th P FP S
n r a y e x h i b it tig h tn e ss o f str u ctu r e s th a t a tta ch to the
l a t e r a l b o r d e r o f th e p a te lla , su ch a s tlr e la teral
57
r e t i n a c u l u r n .:1 1
T ig h tn e ss o f th e la te r a l r e tinacul ar
s t r r i c t u r e s , p e r h a p s a s a r e su lt o f in cr e a se d tensi on i n
t h e i l i o l i b i al b a n d , r n a y a d ve r se ly a lte r tr a cki ng of the
p a t e l l a i n th e tr o ch le a r g r o o ve . T h e th e o r e tical rati o
n a l e f o r m an u a l str e tch in g o f th e la te r a l p a tel l ar
s t r u c t u r e s i s th a t th e a p p lica lio n o f a lo w lo ad, pro
I o n g e d s l r etctr m a y in cr e a se th e le n g th o f tlrese ti ss u e s a n d d e cr e a se th e e xce ssivela te r a l p u ll of these
s t n r c t r l r e s ove r th e p a te lla , a llo win g a n o r m a l track,
i n g o l t h e p a le lla in sid e th e tr o ch le a r g r o o ve. The
b i o l o g i c a l pla u sib ility o f le n g th e n in g so ft tissue to
f a c i l i t a t e a p e r r n a n e n t e lo n _ g a tio nh a s b e e n previ ousl y
r e p o r t e c l i n th e lite r a tu r e ""
R o w l a r r clse t a l5 :j co m p a r e d a g r o u p o f p a ti enl s
w h o r e c e i ve d d e tr r r - r e du ltr a so u n d with a g r o up that
r e r c e i v e da p a te lla r m o b iliza tio n p r o ce d u r e consi sti ng
o l r n a n t r a l su sta in e d g licle fo llo we d b y lr ig h vel oci ty,
l o w - a m p l i t r r clem a n ip u la tio n . T fr e y r e p o r te d tl rertal t h o t r g h n o d il' fe r e n ce wa s fo u n d in fu n ctio n al out
c o r n e b e t w e e n th e g r o u p s, th e p a te lla r m o b ili zati on
g r o u p c l e m o n str a te clsig n ifica n tly lo we r le ve ls of pai n
t h a n t l ) e c o n tr o l g r o u p a t a l- r n o n th fb llo w,up. Thi s
s t u d y w a s assig n e d a sco r e o f 4 8 p o in ts ( T a b l e 5).
T h e s l u d y c lid n o t m e e t th e m in ir n u m le ve l of qual i ty
f b r t h e f o l lo win g ite m s in th e sca le : a d e q u a te numb e r o f s u b j e cts, h o m o g e n e ity o f g r o u p s, b lin ded outc o m e a s s e ssm e n t,fo llo w u p p e r io d a d e q u a te , rand o n i i z a t i o n d e scr ib e d , d r o p o u ts a cco u n te d for, anc
use of intention-to-treat analysis (Table 2). It seems
there rnay be some usefulness for manual therapy in
t h e t r e a t m en t o f PF PS, h o we ve r , th e r e su lts must be
i n t e r p r e t e d in lig h t o f th e stu d y' s q u a lity score.
S u t e r e t a l6 3 d o cu m e n te cl th e p r e se n ce o f
q u a d r i c e p s a ctiva tio n fa ilu r e ( QAF ) in p a tie nts w i th
:rnterior knee pain. QAF is the inability to fully acti
v a t e a . m u s cle d u r in g a m a xim u m vo lu n ta r y c ontract i o n . " A l t h o u g h th e r e is n o e vid e n ce d o cu m enti ng
J Orthop SportsPhysTher . Volumc33 . Number I . January2003
the role of the SIJ in the maintenance of normal
patellofemoral joint mechanics, the authors speculate
that SIJ dysfunction may adversely alter patell ofemoral bi omechani cs. They reported that the pa,
ti ents w ho recei ved a mani pul ati on theoreti cal l y di
rected at the SIJ demonstrated short-term results in
decreasi ng QA F compared w i th pati ents w ho di d not
recei ve mani pul ati on.6a Thi s study w as assi gned a
score of 7l poi nts (Tabl e 5). Thi s tri al di d not meet
the mi ni mum l evel of qual i ty for the fol l ow i ng i tems
i n the scal e: bl i nded outcome assessment,fol l ow up
peri od adequate, and randomi zati on descri bed
(Tabl e 2). Therefore, there seems to be some evi dence that the proposed mani pul ati on approach cl e,
creases QAF. However, the direct effect of this find
i ng on pai n and functi on has not been establ i shed.
Modalities
A nti ch et al z publ i shed the fi rst R C T to i nvesti gate
the effect of di fferent modal i ti es on strength ancl
subj ecti ve i rnprovement for pati ents w i th
chondromal aci a patel l a, i nfrapatel l ar tendoni ti s, zrnd
peri patel l ar pai n. Ice, phonophoresi s, i ontophoresi s,
and ul trasound-i ce contrast w ere compared. 'I'hi s
study w as assi gned a score of l 9 poi nl s (Tabl e 5).
Tfre resul ts suggested that the use of ul trasound-i ce
w as the most efl ecti ve rnodal i ty for treatntent of pai n
i n these pati ents. H ow ever, w e suggest caul i on the
use of these resul ts as evi dence because of the
study s l ow qual i ty score. The onl y i terns i n w hi ch thi s
l ri al met the mi ni murn l evel of qual i l y w ere the sti l n
dardi zati on ancl descri pl i on of i nterventi on and trse
of adequate control ancl pl acebo group (Tabl e 2).
R ogvi H ansen et al '' found no di fference i n syntp
toms betw een pati ents w i th arthroscopi cal l y di agnosed chondromal aci a patel l ae w ho recei ved real or
sharn low'level laser. This trizrl was assigned a score of
58 poi nts (Tabl e 5). Thi s tri al di d nor meet rhe rni nr
mum l evel of qual i ty fbr the fol l ow i ng i l ems of tl re
scal e: adequate number of subj ects, coi nterventi ons
avoi ded, use of rel evant outcome, fol l ow ,up peri od
adequate, descri pti on of rancl omi zati orr, cl ropouts
accounted fbr i n the anal ysi s,and use of an
i ntenti on-to-treat anal ysi s (Tabl e 2). The resul ts of'
thi s study seem to i ndi cate that l ow -l evel l aser treatment i s not effecti ve i n the management of P FP S ,
but the l ow qual i ty of the study does not al l ow a de
fi ni ti ve concl usi on.
Medications
N onsteroi dal anti -i nfl ammatory drugs (N S A ID s)
are commonly used as an adjunct to physical therapy
i n the management of P FP S .43Ful kerson et al l s compared 2 di fferent N S A ID s, di fl uni sal and naproxen,
in patients described as having anterior knee pain
l3
:
rn
F
c
n
m
n
m
:
m
€
and found significant levels of pain relief for both
drugs. This study was assigned a score of 24 points
(Table 5) . The only items in which this trial met the
Acupuncture
minimum
Although the mechanism by which acupuncture
reduces pain is unclear, it is believed to be related to
the gate and endorphi n theori es of pai n reducti on.26
of the patients in this study may have been diagn o s e d with a n te r io r kn e e p a in o th e r th an P FP S .
Jensen et al26 assessedthe effect of acupuncture in
the treatment of PFPS and found significant improvements in pain and function in those patients
Therefore, the subjects could have had a variety of
c o n d i tio n s th a t a r e p r im a r ily in fla m m a tory i n nature
who received acupuncture. This trial was assigned a
score of 83 poi nts (Tabl e 5). The onl y i tem i n the
w h i c h m ig h t r e sp o n d we ll to NSAIDs.
28
Kannus et a127
assesseclthe effect of intra,
a r t i c ula r a n d in tr a m u scu la r in ie ctio n s of
g l y c o a m in o g lyca n p o lysu lla te ( GAGPS) i n the man-
scal e for w hi ch thi s tri al di d not meet the mi ni murrr
l evel of qual i ty w as the i tem rel ated to the descri p,
ti on of randomi zati on (Tabl e 2). B ased on the resu l ts
of thi s study and i n l i ght of i ts qual i ty score, acupuncture appears to be effecti ve i n the treatment of
level of quality were the adequacy of the
n u m b e r o f su b je cts a n d sta n d a r d iza tio n and descri p
t i o n of in te r ve n tio n s ( T a b le 2 ) . It a p p e ars that some
a g e n re n t o f PF PS. Exp e r im e n ta l r e se a r ch has show n
t h a t GACPS ca n in h ib it d e g r a d a tive e n zyme reac
P F-P S .
t i o n s , tlills in h ib itin g th e in fla m m a to r y cascade of
e v e n t s a sso cia te dwith in fla m m a tio n , a nd can sti mul a t e t he r n e ta b o lism o f ch o n d r o cyte s a n d synovi al
c e l l s . 2 7T h e y co m p a r e cl th e u se o f in tr a arti cul ar i n'
j e c t i o ns o f CACPS with p la ce b o in je ctions and no
i n j e c tio n s. T h e r e su lts we r e p u b lisfr e cl in 2 stucl i es, 1
r e p o r tin ^ g ^th e r e su lts a t fo llo w u p s o f 6 weeks and 6
m o n t h s,"' a n cl th e o th e r r e p o r tin g th e resul ts at a
f o l l o w u p o f 7 ye a r s.2 8T h e 3 g r o u p s o f pati ents al so
r e c e i ve cla n e xe r cise p r o g r a m ( iso m e tr ic quadri ceps
a n d str e tch in g ) a n d o r a l clo se so f th e NS A ID
p i r o x ica m d u r in g th e in iti;r l 6 we e k p e r i od of rehab i l i t i r tio n . T h e se str r clie sr e p o r le d th a t al 6 w eek,zT
6 m o n th ,2 7 a n d 7 ' ye a r I' o llo w- u p s,2 8th e use of i ntra
; r r t i c ula r in je ctio n s o f CAGPS d o e s n o t i nfl uence the
o u t c o m e o f r e h a b ilita tio n in p a tie n ts with P FP S part i c i p a tin g in a q u a d r ice p s e xe r cise p r o g rarn. Tfrese
l r i a l s w e r e a ssig n e d sco r e s o f 7 6 2 7 a n cl 80 poi nts,z8
r e s p e ctive ly ( T a b le 5 ) . Bo th tr ia ls d id n ot meet the
m i n i r nu m le ve l o f q u a lity lo r th e cr ite r ia rel ated to
u s e o f a n in te n tio n to tr e a t a n a lvsis.Ad di ti onal l v. the
f i r s t t r i:r 1 2 7clicl n o t m e e t th e m in im u r n level of qual i t y l b r b lin d e d o u tco m e a sse ssm e n t,wh ereas ttre sec
o n d t ria lz8 d id n o t m e e t th e m in im u m l evel of qual i t y f o r ir o r n o g e n e ity o l g r o u p s a n d co in terventi ons
a v o i c le d ( T a b le 2 ) . An o th e r stu cly5 oth a t i nvesti gated
a s i m i la r h yp o th e sis r e p o r te d r e su lts th at confl i cted
w i t h t he o n e a b o ve . ln a tr ia l th a t wa s assi gned a
s c o r e o f 7 5 p o in ts ( T a b le 5 ) , Ra a tika in en et al su report€d positive results with intramuscular injections
o f C A GPS in p a tie n ts with a r th r o sco p ical l y veri fi ed
d a m a g e o f p a te lla r ca r tila g e . Ho we ve r , the type of
i n j e c t i o n ( in tr a m u scu la r ve r su s in tr a - a r t i cul ar) and
patient selection criteria were different between the
2 s t u die s. T h is tr ia l d id n o t m e e t th e m i ni mum l evel
of quality for the description of randomization and
use of an intention-to-treat analysis (Table 2). Although the above studies seem to possess a sufficient
level of quality, the role of injection of CAGPS rem a i n s u n cle a r b a se d o n th e co n tr a d icto ry fi ndi nqs of
t h e s tu d ie s.
I4
Strength
TrainingMethods
Werner et al 72 demonstrated that pati ents w i th
P FP S exhi bi ted decreased strengl h and reduced
el ectromyographi c acti vi ty duri ng a seal ed knee extensi on exerci se comparecl l o subj ects w ho cl i d not
have P FP S . The restorati on of quadri ceps muscl e
strength has been found to correl ate w i th the l ong
term outcome i n pati ents w i th P I,P S .4:l
Ta
Tw o R C TsGT assesseclquadri ceps trai ni ng mel h
ocl s and found no me:rsurabl e di fference of any rel
evant outcome betw een the di fferent approacl res i n
vesti S ated.Wi tvrouw et al 74 eval uatecl the etfi cacy of
non w ei ght beari ng exerci ses versus w ei ght-beari ng
exerci ses i n pati ents w i th patel l ofemoral pai n. A l '
though they reported decreased pai n and i ncrease d
functi on i n both groups, no di fference i n pai n,
muscl e perforrnance, and functi onal outcomes be
tw een groups w as observed. Tl romce el al {i 7, onr
pared i sometri c and eccentri c trai ni ng programs an d
observed no overall differences in physical activity,
pai n, or rnuscl e functi on betw een groups. The stucl i es by Wi tvrouw et al Ta and Thomee et al 67 w ere as si gned scores of 75 and 69 poi nts, respecti vel y (Tab l e
5). B oth of these tri al s di d not meet the mi ni mum
l evel of qual i ty for the i tem rel :rted to bl i nded out,
come assessment.A ddi ti onatl y, the Wi tvrouw et al Ta
tri al di d not meet the cri teri on for adequacy of the
[ol l ow up peri od, w hereas tl re Thomee et al 'j 7 tri al
di d not meet the mi ni mum l evel of qual i ty for ad
equate number of subj ects, adequacy of control and
pl acebo group, and coi nterventi ons avoi ded (Tabl e
2). The fact that al l the groups i n both tri al s demon ,
strated some i mprovement i n functi on and decreas e
i n pai n, suggeststhat there i s moderate evi dence th at
non-w ei ght'beari ng, w ei ght-beari ng, i sometri c, and
eccentric exercises may be useful in the management
of P FP S ; how ever, no si ngl e approach has been dem onstrated to be superior to another.
J Orthop SportsPhysTher . Volume33 . Number I . January2003
Combinedtreatments
The rationale for trials to combine different treat'
ment approaches likely involves an effort to simulta,
neously ameliorate as many impairments associaled
w i t h P F P S as p o ssib le . M a n y stu d ie s h a ve in vesti gated
t h e i m p a i r me n ts a sso cia te dwith PF PS. So m e stud
i e s 6 27 : l d e m o n str a te d th a t d e cr e a se d q u a d r iceps
s t r e n g t h a nd d e cr e a se d h a m str in g s a n d q u a dri ceps
flexibility are risk factors for the development of ant e r i o r k n e e p a in .l:r It h a s b e e n th e o r ize d th a t dec r e a s e d f l e xib ility o f th e ilio tib ia l b a n d /te n so r fasci a
l a t a c o m p l ex, a n d tig h tn e ss o f th e la te r a l r e tinacul ar
t i s s u e sm a y a lso co n tr ib u le to PF PS.a6 :lt 5 77 r 1r'ru66i t i o n , s o m e a u th o r s su g g e st th a t m u scle im b a lance
b e t w e e n t h e va stu s m e d ia lis o b liq u e ( VM O) and
v a s t u s l a t e r a lis co n tr ib u te to a te n d e n cv fo r the oa
t e l l a t o l a t er a lly su b lu x,:ls b u t tlle r e is little e vi dence
t o s u b s t a n tia te th is h yp o th e sis, a n d th e r e is increasi n g e v i d e n ce th a t th is is in fa ct n o t th e ca se .s2e4{)
T I t e a n a t o m ica l d iffe r e n tia tio n b e twe e n th e fi bers of
t l r e V M O an d fib e r s o f th e va stu s m e d ia lis la teral i s
h a s a l s o b e e n r e ce n tly q tr e stio n e d .2 l We fo u nd 4
R C T s t h a t use d a co m b in a tio n o f d iffe r e n t e xerci ses.
p a t e l l a r t a p in g , o r th o tics, b io fe e d b a ck, a n d pati ent
education.
H a r r i s o n e t a l2 0 p e r fo r m e cl a stu cly co m p a ri ng 3
g r o u p s t h a t r e ce ive d d iffe r e n t tr e a tr n e n ts: ( l) l ow er
e x t r e n r i t y str e n g th e n in g a n d str e tch in g e xe r ci ses perf b r r n e c l a s a h o m e p r o g r a im ; ( 2 ) lo we r e xtr e mi ty
s t r e n g t h e n in g a n d str e lch in g e xe r cise s p lr r s stretchi ng
o f t h e l a t e r a l r e tin a cu la r str u ctu r e s su p e r vised by a
p h y s i c a l t h er a p ist; ( 3 ) sa m e zr sg r o u p 2 p lu s patel l ar
t a p i n g a n d b io fe e d b a ck te ch n iq u e d ir e cte d to the
V M O m u s c le . T h e y fo u n cl sig n ifica n t ir n p r o vement i n
p a i n a n d f u n ctio n lo r g r o u p 3 a t th e I m o n th fol l ow '
u p . H o w e v er , n o d iffe r e n ce s we r e d e te cte d b etw een
t h e r e h a b i l ita tio n p r o g r a m s a t a l- ye a r fo llo w up.
T h i s s t u d y w a s a ssig n e d a sco r e o f 7 2 p o in ts (Tabl e
5 ) . T h i s t r i al d id n o t m e e t th e m in im u m le vel of
q u a l i t y f o r r h e fo llo win g ite m s in th e sca le : b l i nded
o u t c o m e a sse ssm e n t,fo llo w r .r p p e r io d a d e q u ate, and
d e s c r i p t i o n o f r a n d o m iza tio n ( T a b le 2 ) . Alth ough no
d i f f e r e n c e s we r e d e te cte d a t th e 1 - ye a r fo llo w-up, the
i m p r o v e m e n ts r e p o r te d a t 1 - m o n th m a y still justi fy
i n t e r v e n t i o n b a se d o n th e p o te n tia l to r e so lv e the
p a t i e n t ' s c o m p la in ts so o n e r .
C l a r k e t al6 fo u n d n o sig n ifica n t d iffe r e n ces at a
1 - y e a rf o l l o w- u p b e twe e n 4 g r o u p s th a t in co r porated
t l ' r e f o l l o w i ng in te r ve n tio n s: ( 1 ) e xe r cise , ta p ing, and
e d u c a t i o n ; ( 2 ) e xe r cise a n d e d u ca tio n ; ( 3 ) tapi ng
a n d e d u c a tio n ; a n d ( 4 ) e d u ca tio n a lo n e . Ho w ever,
p a t i e n t s w h o r e ce ive d th e e xe r cise p r o g r a m w ere si gnificantly more likely to be discharged after 3
m o n t h s c o mp a r e d to p a tie n ts wh o d id n o t r ecei ve
exercise. Patient satisfaction was used as the criterion
for discharge. There were no significant differences
in pain, anxiety and depression, quadriceps strength,
J Orthop SportsPhysTher . Volume33 . Numbcr I . January2003
and functi on at the 3-month and 1-year fol l ow ups.
This study was assigned a score of 80 points (Table
5). Tni s tri al di d not meet the mi ni mum l evel of
qual i ty for the i tems rel ated to adequate control and
pl acebo group and coi nterventi ons avoi ded (Tabl e
2). S i mi l ar to H arri son et al ,z{)based on the abi l i ty to
qui ckl y resol ve a pati ent's compl ai nts, even shortterm i mprovements that are not necessari l y mai n,
tai ned over a l onger peri od of ti me may sti l l be suffi
ci ent to j usti fy i nterventi on.
R oush et al 52 exami ned 3 treatments: (1) a home
program that used tradi ti onal strai ght l eg,rai si ng and
pi l l ow -squeezi ng exerci ses; (2) a physi cal therapy pro
gram conducted over 18 physi cal therapy sessi ons
consi sti ng of stretchi ng, strengtheni ng, patel l ar mobi
l i zati on, tapi ng, orthoti cs, and aerobi c exerci se; and
(3) a speci al home program tfrat i ncorporated a
modi fi ed strai ght l eg rai se purported to be speci fi c
for i sol ati ng the V MO. R ecrui tment of the V MO w as
not i nvesti gated duri ng the tri al . They reported i rnproved pai n and functi on at 12 w eeks for subj ects i n
group 3. Thi s study w as assi gned a score of 54 poi nts
(Tabl e 5). Thi s tri al di d not meet the mi ni mum l evel
ol qual i ty for the fol l ow i ng i tems i n the scal e: adequate nunrber of subj ects, homogenei ty of groups,
coi nterventi ons avoi ded, use of rel evant outcome,
fol l ow 'up peri od adequate, descri pti on of randomi za
ti on, i ntenti on-to treat anal ysi s, and use of proper
stati sti cal procedures (Tabl e 2).
=
Fl
F
c
n
m
E burne et al l s comparecl a group that recei ved
i sornetri c quacl ri ceps exerci ses and functi onal re-
F
trl
educati on w i th a group that recei vecl McC onnel l 's
regi men (i e, patel l ar tapi ng, V MO trai ni ng, eccentri c
muscl e acti on i n w ei ght beari ng, and functi onal ac
ti vi ti es). The onl y si gni fi cant di fference w as that
few er pati ents w ho recei ved McC onnel l 's regi men
exhi bi ted a posi ti ve symptom provocati on test upon
compl eti on of the treatment, how ever, there w ere nr.t
di ff'erences i n the pri mary pai n outcome measure.
Thi s tri al w as assi gned a score of 48 poi nts (Tabl e 5).
The study di d not meet the mi ni mum l evel of qual i ty
for the fol l ow i ng i tems i n the scal e: control and pl a'
cebo adequate, coi nterventi ons avoi ded, use of rel evanl outcome, fol l ow -up peri od adequate, descri pti on of randomi zati on, and use of an i nl enti on'totreat anal ysi s (Tabl e 2).
Several trials8 ls 20s2 lrave investigated the use of a
combi ned treatment approach i n the management of
P FP S . E xcept for I tri al ,'' each demonstrated a rel atively short-term treatment effect in improving pain
52
ancl function2o
or the rate of discharge from physical therapy based on pati ent sati sfacti on.6Tw o of the
20
4 tri al s8 al so had qual i ty scores that exceeded 70
(Tabl
e 5). B ased on the evi dence from these
poi nts
tri al s and i n l i ght of thei r qual i ty scores, there ap'
pears to be some evi dence for the use of a combi ned
treatment approach i n the management of P FP S .
t5
:
€
Areasof lmprovement
and Practical
Applications
A secondary purpose of this review was to objectively identify and discuss specific areas in the clinical
research process that need to be improved in future
c l i n i c al tr ia ls. If im p r o ve m e n ts in th e se areas coul d
b e i n c o r p o r a te d in to th e d e sig n o f fu tu re cl i ni cal
t r i a l s , th e e n d r e su lt wo u ld b e a n im p r ovement i n
t h e v a lid ity a n d g e n e r a liza b ility o f th e r esul ts from
t h e s e stu d ie s. T h e a r e a s o f th e clin ica l research pro,
c e s s t ha t m a y n e e d to b e im p r o ve d b a sed on the pred e f i n ed cu to ff sco r e s ( ie , th o se a r e a s in w hi ch 70ol o
o r l e ss o f th e tr ia ls sa tisfie d th e m in im u m l evel of
q u a l i t y fo r th a t cr ite r io n ) a r e b r ie fly d isctrssedi n the
o r d e r o f th e lo we st to h ig h e st p e r ce n ta ge of tri al s for
e a c h c r ite r io n .
F ' a ilu r e to a p p r o p r ia te ly r a n d o m ize subj ects to
t r e a t me n t g r o u p s wa s th e cr ite r ia th a t s cored the l ow
e s t u s in g o u r sca le . Alth o u g h a ll stu d ie s i n thi s re
v i e w we r e p u r p o r te d to b e a n RCT , o n ly 257o of al l
t r i a l s me t th e m in im u m r e q u ir e n r e n t fo r appropri ate
r a n d o m iza tio n ( T a b le 2 ) . F a ilu r e to r a ndoml y al l o
c a t e pa tie n ts to tr e a tm e n t g r o u p s, wh ich may i ncl ude
u s i n g a n in a d e q u a te r a n d o m iza tio n p r o cedure, i s
b e l i e ve d 1 0 b e th e m o st im p o r ta n t fa ctor contri buti n g i t o b ia s in clin ica l tr ia ls.s8 Ra n d o m al l ocati on
a m o n g a str fficie n tly la r g e sa m p le te n d s to di stri bute
i n i p o r la n t va r ia b le s, b o th kn o wn a n d u nknow n,
e q u a l ly a cr o ss tr e a tm e n t g r o u p s. T h is h el ps to ensure
t h a t a t th e b e g in n in g o f tr e a tm e n t g r o ups are si mi l ar
w i t h r e sp e ct to ch a r a cte r istics o th e r th a n treatment
a s s i g n m e n t th a t m ig h t in flu e n ce th e o u tcome. In thi s
m i l n n er , o n e ca n b e co n fid e n t th a t tl) e observed
t r e a t me n t e ffe ct ca n b e a ttr ib u te d to th e treatmenl
o f i n t e r e sl a n d th a t ca u sa l r e la tio n sh ip s can be i dentified.
T h e cr ite r io r r th a t a d d r e sse ( l th e h o mogenei ty of
t h e t r e iltm e n t Sr o u p s a t b a se lin e wa s m et i n 65% of
t h e t r ia ls ( T a b le 2 ) . T h e fa ilu r e to u se an appropri
a t e r a n d o m iza tio n p r o ce d u r e m a y p a r tial l y account
f o r t h e a p p a r e n t la ck o f sir n ila r ity b e tween the
g r o u p s a t b a se lin e . T h e r e a so n it is n e cessary to test
f o r h on r o g e n e ity o f th e tr e a tr n e n t g r o u ps under i n
v e s t i ga tio n is to a ssu r e th e r e a d e r th a t the random'
i z a t i o n p r o ce ss a ctr ie ve d its g o a l. In th e absence of
p r o p e r r a n d o m iza tio n , e ve n wh e n th e groups are
d e m o nstr a te d to b e h o m o g e n o u s fo r th e chosen
t e s t e d va r ia b le s, it is p o ssib le th a t a n o th er i mportant
variable overlooked by the researcher (eg, level of
physical activity, strength) could still affect the outcome and bring the validity of the results into ques
tlon.
O n l y 3 0 % o f tr ia ls m e t th e m in im u m requi rement
to follow subjects for a sufficiently long period after
treatment (Table 2). ln general, the follow-up period
must at least be sufficiently long for the outcome of
interest to appear. Treatment effects tend to "wash
o u t " o ve r tim e , m e a n in g th a t a s tr e a tm ent groups
IG
get farther from the time in which they were exposed to treatment, they become more equal with
respect to the outcome of interest. This may or may
not i nfl uence one's i nterpretati on of the cl i ni cal
meaningfulness of the results of a study. For ex
ampl e, even short term i mprovements i n pai n and
function potentially may have implications for de
creasing costs associated with treatment and prevention of future injury. In most trials assessing physical
therapy interventions, a follow up period of at least 6
months to 1 year i s i deal , al though fol l ow -up for
even l onger peri ods i s even better. H ow ever, i f the
outcome of i nterest i s expected to appear w i thi n i r
I'ew days, such as an i mprovement i n pai n, or the
nature of the research questi on j usti fi es a short term
outcome, a short t€rm fol l ow up peri od may be approprl ate.
Onl y 35% of the tri al s met the mi ni mum l evel of
qual i ty for acl equate bl i ndi ng ol botl 'r cl i rri ci ans and
outcomes assessors(Tabl e 2). Increased effect si zes
have been associ ateclw i th a fai l ure to cl oubl e bl i nd.51l
When at al l possi bl e, subj ects, outcomes assessors
(techni ci ans, exami ni ng cl i ni ci ans, etc), and even the
i nvesti gators not parti ci pati ng i n the data col l ecti on
process, shoul cl be bl i ncl to treatrnent assi gnment
and outcomes. H ow ever, because subj ects must be
made aw are of potenti al treatment group assi gnrnents w hen they provi de i nformecl consent, bl i ncl i n g
of subj ects i n tri al s assessi ngphysi cal therapy i nter
venti ons can be qui te probl emati c as desi gni ng a
genui ne pl acebo can be di ffi cul t, i f not i mpossi bl e
l {ow ever, i nvesti gators can sti l l be extrernel y careful
to :rvoi d i ni pl yi ng to subj ects w hi ch treatment i s l )y
pothesi zed to be most effi c:rci ous. l nvesti gators can
al so assure that outcomes assessorsremai n bl i ncl ed to
treatment group assi gnn)ent. The use of sel f'report
tneasures of outcorne hel ps to mi ni mi ze bi as associ
zrted w i th the fai l ure l o bl i ncl outcomes assessors,as
the pati ent's sel f report i s not readi l y subj ect to bi as
from tl re i nvesti gator or cl i ni ci an. H ow ever, for ntea,
sures subj ect to rater bi as, such as range of moti orr
or muscl e strength, i t i s i mperati ve to uti l i ze separate
"treati ng" and "exami ni ng" cl i ni ci ans. Thi s hel ps to
ensure that the treati ng cl i ni ci an i s bl i nded from the
outcome and the exami ni ng cl i ni ci an i s bl i ndecl Iro rn
treatment group assi gnment. S ubj ects must al so be
gi ven speci fi c i nstructi ons and frequentl y remi nded
to avoi d di vul gi ng bl i nded i nformati on to ei ther the
l reati ng or exami ni ng t l i ni ci an.
A dequate control of coi nterventi ons w as reported
in only 457o of the reviewed trials (Table 2). Exrraneous factors such as use of pai n medi cati on and par
ti ci pati on i n sports may i nfl uence the effect of the
i nterventi on under study on the outcome of i nteres t
i n P FP S , resul ti ng i n the i nabi l i ty to attri bute the
outcome sol el y to the experi mental treatment. If an y
coi nterventi on cannot be el i mi nated or mani pul ated
J Orthop SportsPhysTher . Volume33 . Number I . january2003
to be equally applied to both the experimental and
control group, and it is associated with the outcome
of interest. then the cointervention should be acc o u n l e d f o r in th e d a ta a n a lysis ( e g , u se d a s covari ate).
The criterion for intention-to'treat (lTT) was met
by only 50o/oof the trials in this review (Table 2).
The failure to analyze the data based on the ITT
p r i n c i p l e h a s b e e n fr e q u e n tly d e m o n str a te d to l ead
t o b i a s i n clin ica l tr ia ls.:laa { ;s8T o co n d u ct a n ITT
analysis, the researcher analyzes all subjects within
t h e g r o u p to wh ich th e y we r e o r ig in a lly a ssigned, re
g a r d l e s s o f wh e th e r th e y co m p le te d th e o r ig inal
t r e a t m e n t , dr o p p e d o u t o f th e stu d y co m p le tel y, or
c r o s s e d o v er to a d iffe r e n t lr e a tm e n t g r o u p . By doi n g a n I T T , th e r e se a r ch e r a cco u n ts fo r a n y system'
a t i c r e a s o n s a s to wh y su b .je ctsd r o p p e d o u t of tfre
stLldy.
" f h e c r i t e r ia th a t a d d r e sse d th e a cco u n ta b il i ty for
w i t f r d r : r w a lsa n d d r o p o u ts wa s m e t in 7 0 ' % o f the tri a l s ( T a b l e 2 ) . F o r clin icia n s to a r r a lyze th e fe asi bi l i ty
o f a s t u d i e d tr e a tr n e n t, r e se a r ch e r s m u st in clude de
t a i l s o f ' t h e n u m b e r o f a n d sp e cific r e a so n s for subj e c t s w h o d r o p o u t o f e a ch tr e a tm e n t g r o u p . It i s
i r n p e r a t i v e to h a ve a cle a r d e scr ip tio n o f th e reasons
I b r s u b j e c t s d r o p p in g o u t a n d to a ckn o wle d g e any
a c l v e r s ee v en t to a llo w d e le r m in a tio n o f th e potenti al
s i c l e e f f e c t s a n d r isks a sso cia te d with th e tr e a tments.
A d r a m a t i c ally d iffe r e n t d r o p o u t r a te b e twe e n groups
w i t h r e a s o ns r e la te d to th e sid e e ffe cts o r la c k of feas i b i l i t y o f t h e tr e a tm e n t u n d e r in ve stig a tio n provi des
t l l e c l i n i c i a n a clu e th a t tfr e p a r ticu la r tr e a tment, de
s p i t e a n y e ffica cy th a t h a s b e e n d e m o n str a te d, may
n o t b e p r a ctica l o r sa [e in clin ica l p r a ctice .
T l r e s i z e o f th e sa m p le wa s co n sid e r e d a p propri ate
i n 6 0 % o f th e tr ia ls ( T a b le 2 ) . T h e n u m b e r of sub
. j e c t si n a s tu d y is im p o r ta n l wh e n in te r p r e tin g the
r e s u l t s . S a mp le size is d ir e ctly p r o p o r tio n a l to the
s t a t i s t i c a l p owe r o f th e stu d y. F a ilu r e to d e r n onstrate
s t a t i s t i c a l l ysig n ifica n t d iffe r e n ce s sh o u ld n o t be as
s u m e d t o me a n tl) a t n o d iffe r e n ce tr u ly e xists w i th
o u t a d e t e r m in a tio n a s to wh e th e r th e stu d y had suf
l i c i e n t p o w er . Wh e n th e sa m p le size is in a d e quate,
t h e p o s s i b i l ity o f n o t lin d in g a d iffe r e n ce in the eff e c t o f t h e tr e a tm e n ts u n d e r in ve stig a tio n , when i n
r e a l i t y t h e r e is a d iffe r e n ce , m u st b e co n sid e red (i e,
T y p e I I e r r or ) .
O f t h e a p p r a ise d tr ia ls, o n ly 6 0 % o f th e tr ial s met
t h e m i n i r n a l r e q u ir e m e n t fo r th e u se o f r e le vant out'
c o m e ( T a b l e 2 ) . T o a ch ie ve m e a n in g fu l r e su lts, i t i s
e s s e n t i a l t o in co r p o r a te r e lia b le , va lid , a n d r esponsi ve
o u t c o m e m ea su r e s th a t r a te sym p to m s, im p a irments,
a n d f u n c t i on a l lim ita tio n s sp e cific to p a tie n ts w i th
P F P S . M o r e o ve r , it is im p o r ta n t th a t th e o u tcome
m e a s u r e p r op e r ly a d d r e sse sth e r e se a r ch q u e s ti on. In
a r e c e n t p u b lica tio n , M a r x e t a l3 3 co m p a r e d the rel i '
ability, validity, and responsiveness of 4 self-reported,
k n e e - s p e c i fic,h e a lth r e la te d o u tco m e sca le s in ath
J Orthop SportsPhysTher . Volurne33 . Number I . January2003
letic patients with a variety of knee disorders, including PFPS. Although the 4 scales demonstrated adequate psychometric properties, they recommended
the use of the Activities of Daily Living Scale of the
K nee Outcomes S urvey to assessphysi cal functi on i n
thi s popul ati on of pati ents.2a66
In a busy clinical practice, it may be both unreasonabl e and unnecessary for cl i ni ci ans to actual l y use
a qual i ty scal e and assi gn an i ndi vi dual score for
each consideration to obtain an overall quality score.
H ow ever, cl i ni ci ans can rel ati vel y qui ckl y j udge the
overal l qual i ty of a treatment study w i th respect to
these problematic areas that may be associated with
bi as i n a study's resul ts si mpl y by l ooki ng for key
w ords i rt the methodol ogy and resul ts secti on such
as, "randomi zati on," "bl i nd," "coi nterventi ons."
"fol l ow up," "i ntenti on to treat," etc. Thi s bri ef
gl ance can gi ve cl i ni ci ans an i ni ti al i mpressi on as to
w hether the study i s of suffi ci ent qual i ty to w arranl
appl yi ng the stucl y's resul ts to thei r pati ents w i th
si mi l ar characteri sti csas those usecl i n the study w i l hout havi ng to assi gn a defi ni ti ve qual i ty score. H ow ever, cl i ni ci ans shotrl d al w ays use cauti on i n ttre deci
si on to accept or rej ect treatment approaches based
on a l i rni ted number of tri erl s,especi al l y those tt-rat
are not hi gh qual i ty studi es. On the other hand, one
very hi gh'qual i ty R C T may i n fact be suffi ci ent to
base a treatment deci si on on, so l ong as the cl i ni
ci an's pati ent i s si mi l ar to the subj ects i ncl ucl ed i n
the study.
A l though several of the tri al s i n thi s revi ew demon
strated a treatment effect for an i nterventi on, others
cl i d not. P eri raps the i nabi l i ty 10 demonstrate a thera
peuti c ef'fect for some of the physi cal therapy i nter,
venti ons for the treatment of P FP S may be because
the researchers di d not account for l he exi stence o[
di fferent subgroups of pati ents w ho requi re a speci fi c
type of treatment approach. In such a cl assi fi cati on,
each subgroup of pati ents w oul d be characteri zed by
a set of key si gns and symptoms that cl i ni ci ans coul d
use to match the pati ent's fi ndi ngs w i th a w el l defi ned treatment approach tai l ored to that sub
group. If cl i ni ci ans w ere abl e to stage pati ents w i th
P FP S appropri atel y and then matcfr each presenta
ti on w i th a targeted treatment based on those key
signs and synlptoms, significant improvements in the
outcome of tri al s l hat assessnonoperati ve treatments
for PFPS would be expected. Ideally, the results of
the cl i ni cal exami nati on w oul cl gui de the cl i ni ci an
dow n one of a fi ni te number of paths of an easy-to
use treatment based al gori thm demonstral ed to be
rel i abl e and val i d i n pati ents w i th P FP S . Treatment
progressi on w oul d then be based on the pati ent's
achi evement of certai n cl i ni cal mi l estones and the
cl i ni ci an's abi l i ty to detect cl i ni cal l y i mportant i mprovements in impairments and measures of func'
tion and disability. In this manner, an evidence-based
approach could be used for the management of the
t7
=
rr'l
n
c
n
m
n
m
:
m
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patient across the entire spectrum of the patient's
course of care, from the initial examination to the
p a t i e n t' s r e tu r n to fu ll fu n ctio n . De ve lopi ng effecti ve,
clinical methods for classifying patients with PF'PS
s h o u l d im p r o ve clin ica l d e cisio n m a kin g and treat'
ment outcomes by matching treatments to the pat i e n t s m o st like ly to b e n e fit fr o m th e m . C l assi fi cati on
m e t h od s will a lso e n h a n ce th e p o we r o f cl i ni cal re
s e a r c h in p a tie n ts with PF PS b y p e r m itti ng research,
e r s t o stu d y m o r e h o m o g e n o u s g r o u p s of pati ents.
A nti ch TJ, R andal l C C , Westbrook R A , Morri sseyM C ,
B rew sterC E . P hysi caltherapy treatmentof knee ext en,
sor mechani smdi sorders:compari sonof four treatm ent
modal i ti es.I Orthop S portsP hys Ihei : 1986;B (5):255259.
A rrol l B , E l l i s-P egl erE , E dw ardsA , S utcl i ffeG. P atel l ofemoral pai n syndrome. A cri ti cal revi ew of t he
cl i ni cal tri al s on nonoperati vetherapy. A m J S p orts
Med. 1991:25(2):201212.
B rody LT, Thei n JM. N onoperati vetreatmentfor patetl ofemoral pai n. I Orthop S ports P hys Th er.
'1998;28(5):336-344.
CONCLUSION
B a se d o n th e r e su lts o f tr ia ls th a t se emed to ex
h i b i t a su fficie n t le ve l o f q u a lity, tr e a tm ents that
s e e m e ffe ctive in d e cr e a sin g p a in a n d improvi ng
f u n c t i o n in p a tie n ts with PF PS a r e a cu puncture,
q u a d rice p s str e n g th e n in g , th e u se o f a resi sti ve
b r a c e , a n d th e co m b in a tio n o f e xe r cises w i th patel l ar
t a p i n g a n d b io fe e d b a ck. T h e u se o f so ft foot orthoti c s i n p a tie n ts with e xce ssivefo o t p r o n a ti on appears
u s e f u l to d e cr e a se p a in . In a d d itio n , a t a short'term
f o l l o w u p , p a tie n ts wh o r e ce ive d e xe r cise programs
w e r e mo r e like ly to b e d isch a r g e d e a r lier from physi
c a l t h e r a p y.
M o st RCT s we r e vie we d co n ta in e d q u al i tati ve l l aw s
t h a t n r a y b r in g th e va lid ity o f th e r e su lt s i nto ques
t i o n , th u s d im in ish in g th e a b ility to g e neral i ze the
r e s u l t s to clin ica l p r a ctice . T h e se fla ws w ere pri rnari l y
i n t h e a r e a s o f r a n d o m iza tio n p r o ce d u r es, durati on
o f f o l lo w- u p , co n tr o l o [ co in te r ve n tio n s, assurance of
b l i n d i ng , a cco u n la b ility a n d p r o p e r a n al ysi s of drop
o u t s , nu m b e r o f su b je cts, a n d r e le va n ce of the out
c o m e s. M o r e h ig h - q u a lily clin ica l tr ia ls are needed to
e l u c i d a te th e m o st e ffe ctive tr e a tm e n t s trategi es for
p a t i e n ts with PF ' PS.T r ia ls o f h ig h q u a lity w i l l support
t h e c l i n ica l d e cisio n r n a kin g p r o ce ss in the care of
o u r p a tie n ts a n d h e lp to p r o vid e str o n g evi dence
t h a t c a n co n tr ib u te to th e r e co g n itio n of the val ue of
p h y s i ca l th e r a p y. Give n th e lim ite d n u m ber of hi gl rq u a l i t y clin ica l tr ia ls, r e co m m e n d a tio n s to support or
r e f u t e sp e cific tr e a tm e n t a p p r o a ch e s m ay be premat u r e a n d ca n o n ly b e m a d e with ca u tio n.
T h e a u th o r s wo u ld like to th a n k Go g il avaani P i l l ai ,
S h e r r y He ise r , Er ica Ba u m , a n d M a r k Schmel er for
a s s i s t in gwith th e lite r a tu r e r e vie w a n d arti cl e re
t r i e v a l . We wo u ld a lso like to th a n k Cr e gory H i cks,
S t e v e Ge o r g e , Ke lle y F - itzg e r a ld ,a n d Ja y l rrgang for
a s s i s t in gwith sco r in g th e tr ia ls th a t we r e i ncl udecl i n
the review.
'1 0
1',]
12
14
I5
11
1B
19,
20.
REFERENCES
l8
B.
to
ACKNOWLEDGEMENTS
1 . A ltm an DG, Bland JM. Absence of ev i denc e
e vidence of absence BM l. 1995:311 ( 700 3) :485
1.
i s not
C erny K . V astusmedi al i sobl i que/vastus
l ateral i smus c l e
acti vi tyrati osfor sel ectedexerci sesi n personsw i th and
w i thout patel l ofemoral pai n syndrome. P hys Ther.
1995;75(8):672-683.
C esarel l iM, B i ful co P , B racal eM. S tudy of the conrrol
strategyof the quadri ceps muscl es i n anteri or kn ee
pai n. /fF[ TransR ehabi tfng. 2000;B (3):330-341.
C hesw orthB M, C ul ham E G, Tata GE , P eat M. V ati c i ataon of outcome measures i n pati ents w i th pa tel ,
lofemoral syndrome. J Orthop Sports Phys Iher
1989;10(B ):302308
C l ark D l , D ow ni ng N , Mi tchel l J, C oul sonL, S yzprytFP
D oherty M. P hysi otherapyfor anteri or knee pai n : a
randomi sed control l ed tri al . A nn R heum D i s
2O0O;s9(9):700
704.
C l arke M, Oxman A D . C ochraneR evi ew ers'H andbo ok
4.1.4. Ihe C ochraneLi brary;2001.
C rossl ey K , C ow an S M, B ennel l K L, McC onnell J .
P atel l artapi ng: i s cl i ni cal successsupportedby scien
ti fi c evi dence?Man Ther.2000;5(3):142150.
C rossl ey K , B ennel l K , Green S , McC onnel l J. A
systematacrevi ew of physi cal i nterventi onsfor pa tel .
l ofemoral pai n syndrome. C l i n I S port Me d.
2001;11(2):103110.
D i Fabi o R P What i s "evi dence"?i Orthop S portsP hy s
Ther.2OOO:30(2):52
55.
D uftey MJ, Marti n D F, C annon D W, C raven T, Mes s i er
S P E ti otogi cfactorsassoci atedw i th anteri orknee pai n
i n di stance TU nners. Med S cl S ports E xe rc .
2000;32(1
1):1825-1832.
D ye S F,S aubl i H U , B i edertR M, V aupelGL. The mosai c
of pathophysi ol ogycausi ng patel l ofemoralpai n: therapeuti c i mpl i cati ons. Oper Tech S ports Me d.
1999;7(2):46-54.
E burneJ, B anni sterG. The McC onnel l reqi men ver s us
i sometri c quadri cepsexerci sesi n the managemen tof
anteri orknee paan.A randomi sedprospecti vecontroll ed
vi at. K nee. 1996;3(3):1
51-1 53.
E ng JJ,P i errynow skiMR . E val uati onof soft foot orth ot
i cs i n the treatmentof patel l ofemoralpai n syndrome.
Phys Ther. 1993:13(2):62 6B; discussion6B 70.
Fi nestoneA , R adi n E L, Lev B , S hl amkovi tchN , Wi ener
M, Mi l grom C . Treatmentof overuse patel l ofem oral
pai n. P rospecti verandomi zedcontrol l eclcl i ni cal tri al i n
a mi l i tary setti ng.C /l n Orthop. 1993:293:2OB -210.
Ful kersonJP ,Fol ci k MA . C ompari sonof di fl uni sala nd
naproxen for rel i ef of anteri or knee pai n. C l i n Th er.
1986;9(S upplC ):59 61
Gregoi re G, D erderi an F, Le Lori er J. S el ecti ngt he
l anguage of the publ i cati ons i ncl uded i n a meta
anal ysi s: i s there a Tow er of B abel bi as? J Cl i n
E pi demi ot.1995;48(1):1
59 163.
H arri sonE L, S heppardMS , McQuarri e A M. A randomj zed control l ed tri al of physi cal therapy treatmentpro
gramsi n patel l ofemoralpai n syndrome.P hysi otherC an.
1999;51(2):93-100.
J Orthop Sports Phys Ther . Volume 33 . Number | . January 2003
2 1 . H u b b ar d JK, Sa m p so nHW, Etle d g eJR. Pr e v atenceand
E ngl i sh: i mpl i cati ons for conduct and reporti ng ol
m o r p h o lo g y o f th e va stu s m e d ia lis o b liq u e muscl e i n
systemati crevi ew s. l ancet. 1996;347(8998):363_366 .
h u m a n ca d a ve r s.An a t Re c. 1 9 9 7 ;2 4 9 ( 1 ) :1 35-142.
40. Moher D , JadadA R , N i chol G, P enman M, Tugw ei lp
2 2 . H u r l e y M V, Jo n e sBW, Witso n D, Ne wh a m D J. R ehaWal sh S . A ssessi ng
the qual i ty of randomi zedcontrol ted
b i l i t a t i o no f q u a d r ice p sin h ib ite dd u e to iso latedrupture
tnal s: an annotatedbi bl i ographyof scal esand check,
t o t h e a n te r io rcr u cia te lig a m e n t.I Or th o p R heumatot.
l i sts.C onrrol C ti n Tri ats.1995;16(1):62-73.
1 9 9 2 ; 5:'415 1 5 4 .
41. Moher D , JadadA R , Tugw ei l P A ssessi ng
the quati ty of
2 3 . l n s a l lJ. Cu r r e n tCo n ce p tsRe vie w:p a te ila r p ai n. I B one
randomi zedcontrol l ed tri al s. C urrent i ssuesand future
Joint Surg Am. 1982:64(1).141-1 52.
di recti ons. l nt J Technol A ssess H eal th C are.
2 4 . k r g a n g JJ, Sn yd e r ,M a ckte rL , Wa in n e r RS, Fu FH ,
'1996;12(2):195-208.
H a r n e rCD. De ve lo p m e n to f a p a tie n tr e p o r tedmeasure
o f f u nctio n o f th e kn e e . J Bo n e Jo in t S urg A m. 42. Moher D , P ham B , Jones A , et al . D oes quati ty of
' 19 9 8 ; 8 0 ( B) :1
reportsof randomi sedtri al s affect esti matesof i nterven13 2 - 1 .14 s.
ti on effi cacy reported i n meta anal yses? Lancet.
2 5 . J a d a dA R, M o o r e RA, Ca r r o ll D, e t a l. Ass essi ngthe
1998;352(91
28):609-613.
q u a l a t y o f r e p o r ts o f r a n d o m ize d clin ica l tri al s: i s
b l i n d i ng n e ce ssa r y?Co n tr o t Ctr n Ir ta ls. 1 9 96;'17(1):1- 43. N atri A , K annus P , Jarvi nenM. Whi ch factors predi ct
the l onq-termoutcome i n chroni c patel l ofemoralpai n
12.
26. Jerrsen
R, Go th e se nO, L ise thK, Ba e r h e imA. A cupunc
syndrome?A 7 yr prospecti vefoi l ow up study.Med S ci
t u r e t r e a tm e n to f p a te llo fe m o r apl a in syn d r o me.J A l tern
S portsE xerc.1998;30(1.1
):1572,1 5j j .
C o m p te m e n M
t e d . 1 9 9 9 ;5 ( 6 ) :5 2 15 2 1.
44. O'S ul l i vanS B , S chmi tz f). P hysi catR ehabi ti tati on:A s.
2 7 . K a n n u sP, Na tr i A, Niittym a ki S, ia r vin e n M. E ffectof
sessmenrand Treatment.2nd ed. P hi l adetphi a,P A : F.A .
i n t r a a r ticu la rg lyco sa m in o g lyca np o lysu lfa tetreatment
D avi s C o.; 1998.
l a in syn d r o m e .A p r o sp ecti ve,ran- 45. P al umboP M, Jr.D ynami c patel l arbrace:a new orthosi s
o n p a t e llo fe m o r a p
d o m r z ed d o u b le - b lin d tr ia l co m p a r in q gl ycosa,
i n the managementof patel l ofemoraldi sorders.A prem i n o q lyca n p o lysu lfa tewith p la ce b o a n d quadri ceps
l i mi nary report. A m J S ports Med. 198.1
;9('1):45_49.
m u s c l e e xe r cise s.Ar th r itis Rh e u m . 1 9 9 2 ;35(9):1053- 46. P eduzzi P , Wi ttes J, D etre K , H ol ford T. A nal ysi s as
' 1 0 6 1.
randomi zed and the probl em of nonadherence:an
2 8 . K a n n u sP, Na tr i A, Pa a kka laT , Ja r vin e nM . An outcome
exampl e from the V eteransA ffai rs R andomi zedTri al of
s t u d y o f ch r o n ic p a te llo fe m o r apl a in syn d r o me.S even
C oronary A rtery B ypass S urqery. S rat Med.
y e a r f o llo w u p o f p a tie n tsin a r a n d o m ize d ,control l ed
1993;'l2(13):1185 1195.
r r i a l .i Bo n e Jo in t Su r gAm . 1 9 9 9 ;8 1 ( 3 ) :3 5 5 -363.
47. Portney LG, Watkins MP. Foundations of Ctinical Re.
2 9 . K a r s t GM ,
Witte tt
GM .
On se t r imi ng
of
search:Applications to Practice. Norwalk, CT: Appleton
e l e c t r o m yo g r a p h ica ctivity jn th e va stu s m ecj i al i sob
& Lange;1993.
l i q u e a n d va stu s la te r a lism u scle sin su b je ctsw i th and 48. P ow ersC M. R ehabi l i tati onof patei l ofemoratj oi ntdi sor,
w i t h o u t p a te llo fe m o r a l p a in syn d r o m e . Phys Ther.
ders: a critical review. ,/ Orthop Sports phys f her.
19 9 5 ; 7 5 ( 9 ) :831- 8 2 3 .
1998;28(5):34s3s4.
3 0 . K e n d a l l F P M cCr e a r yEK, Pr o va n cePG. M u sctes:Test 49. P ow ersC M, Landet R , P erry J. Ti mi nq and i ntensi tyof
i n g a n d fu n ctio n . 4 th e d . Ba lta m o r eM
, D: W i i l i ams &
vastus muscl e acti vi ty duri ng functi onal acti vi ti es i n
W i l k i n s ;1 9 9 3 .
subJectsw i th and w i thout patel l ofemoralpai n. phys
3 1 . K o l o w i ch PA, Pa u lo sL E, Ro se n b e r gT D, F a rnsw orthS .
Iher. 1996;76(9):946,955;
di scussi on956-967.
L a t e r a l r e le a se o f th e p a te lla : in d ica t j ons and 50. R aati kai nenT, V aananen K , Tamel anderG. E ffect of
c o n t r a i n d ica tio n s.Am J Sp o r ts M e d . 1 9 9 0 ; 18(4):359gl ycosami nogl ycanpol ysul fateon chondromal aci apa
365.
tel l ae. A pl acebo-controi l ed1,year study. A cta Orttrcp
3 2 . K o w a l l M G, Ko lk G, Nu b e r GW, Ca ssisiJE, S ternS H .
S cand.1990;61(5).443-448.
P a t e l l arta p in q in th e tr e a tm e n to f p a te llo fe moralparn. 51. R oqvi H ansen B , E l l i tsgaardN , Funch M, D al t Jensen
A p r o sp e ctiver a n d o m ize d stu d y. Am J Sports Med.
M, P ri eske J. Low l evel l aser treatment of
19 9 6 ; 2 4 ( 1) :6 1- 6 6 .
chondromal acj aparettae.l nt Orthop. 1991;15(4):359_
3 3 . M a r x R G, Jo n e sEC,Alle n AA, e t a t. Re tia b itiry,
vati orry,
361.
a n d r e sp o n sive n e ss
o f fo u r kn e e o u tco m e scal es for 52. R oush MB , S evi erTL, Wi tson i K , et al . A nteri or knee
a t h l e t i c p a tie n ts. J Bo n e Jo in t Su r g Am . 2OO1:83pai n: a cl i ni cal compari son of rehabi l i tati onmethocl s.
A ( 10 ) : ' 14 5 9 - 14 6 9 .
C ti n J S portMed. 2OO0,10(1\:22-28.
3 4 . M a y G S , De M e ts DL , F r ie d m a n L M , F u r b erg C , P as- 53. R ow l andsB W B ranti ngham.j W. The effi cacyof patei l a
s a m a n i E. T h e r a n d o m ize dclin ica l tr ia l: b ia s i n anatymobi l i zati on i n pati ents sufferi ngfrom patel l ofemoral
s i s .C i r cu ta tio n 1
. 9 8 1;6 4 ( 4 ) :6 6 9 - 6 7 3 .
pai n syndrome. J Orthop R heumatot. 1999:j (4).1423 5 . M c C o n n e ll JS. T h e m a n a g e m e n t o f ch o n dromal acra
149.
p a t e l l a e: a lo n g te r m so lu tio n . Au str I Physi other. 54. R ubi n B , C otti ns R . R unner's knee. P hysi ci an
19 8 6 ; 3 2( 4 ) :251 2 3 3 .
S portsmed.1980;B (6):49-58.
3 6 . M c C o n n e ll JS, F u lke r so nlP T h e kn e e : p a tel l ofemoral 5 5 S ackett D L, H aynes R B , Guyatt GH , Tugw ei l P D .
a n d s o ft tissu e id u r ie s. In : Z a ch a ze wskiJE, Magee D J
Clinical Epidemiology: A Basic Science for Clinical
a n d Q u ille n WS, e d s. Ath te tic lr yu r ie sa n d Rehabi l i ta
Medi ci ne.B oston,MA : Li ttl e,B row n, & C o.: 19g1.
t l o n . P h ila d e lp h ia ,PA: W.B. Sa u n d e r sCo .; 1996:693
56. S ackettD L, S trauseS E , R i chardsonWS , R osenberoW,
178.
H aynesR B . Lvi dence.B ased
Medi ci ne H ow to praTti ce
3 7 . M c N u t t RA, Eva n sAT , F te tch e rRH, F te r ch erS W. The
and Teach E B M. Znd ed. N ew Y ork, N Y : C hurchi i l
e f f e c t s o f b lin d in g o n th e q u a iity o f p e e r revi ew . A
Li vi ngstone,Inc.; 2000.
r a n d o mize dtr ia l. JAM A. 19 9 0 ;2 6 3 ( 10 ) :13 11- 1 316.
51 S anchi sA l fonso V R osel l oS astre E , Marti nez-sanj uan
3 8 . M i l l e r M D, Hin kin DT , Wisn o wski JW. T h e effi cacy of
V . P athogenesi ot
s anteri or knee pai n syndromp and
o r t h o t i csfo r a n te r io r kn e e p a in in m ilita r y trai nees.A
functi onalpatel l ofemorali nstabi l i tyi n the acti veyoung.
p r e l i m i n a r yr e p o r t. Am J Kn e e Su r g .1 9 9 7 ;1 0(1):10-13.
A m J K nee S urg.1999;12(1):29-40.
3 9 . M o h e r D, F o r tin P, Ja d a d AR, e t a l. Co m p letenessof
5B S chul zK F.S ubverti ngrandomi zati oni n control l edtri al s.
r e p o r t i ng o f tr ia ls p u b lish e d in la n g u a g e sother than
IA MA . 1995:274(1B ):1456-i 458.
J Orthop SportsPhysTher . Volume33 . Number I . January2003
|.
rn
p
F
m
F
trl
:
m
€
5 9 S ch u lz KF ,Ch a lm e r sl, Ha ye s RJ,Altm an D G. E mpi ri cal
e vid e n ceo f b ia s. Dim e n sio n so f m e th odol ogi calqual i ty
a sso cia te dwith e stim a te so f tr e a tm e nteffectsi n cont ro lle d tr ia ls.IAM A. 1 9 9 5 t2 73 ( 5 ) :4 0 84 12.
60 S h r o u t PE, F le iss JL . In tr a cla ssco r r el ati ons:uses i n
a s se ssin rga te r r e lia b ility.Psych o lBu ll. 1979;86(2):4204?8.
6 1 S iko r skiJM , Pe te r sJ, Wa tt L T h e im p o rtanceof femoral
r o ta tio n in ch o n d r o m a la ciap a te lla ea s show n by seri al
r a d io g r a p h y.J Bo n e lo in t Su r g Br . 1 979;61-B (4):4354 42 .
62 S m ith AD, Str o u d L , M cQu e e n C. Fl exi bi l i ty and
a nte r io r kn e e p a in in a d o le sce n te lite fi gure skaters.-/
P e d ia trOr th o p . 19 9 1;11( 1) :7 7 - 8 2 .
6 3. S u te r E, He r zo g W, De So u za kK, Br a y R . Inhi bi ti onof
t h e q u a d r ice p sm u scle s in p a tje n tswit h anteri or knee
p a in . J Ap p t Bio m e ch .1 9 9 B;1 4 :3 6 03 7 3.
6 4 S u te rE, M cM o r la n d G, He r zo gW, Br a y R . C onservati ve
l o we r b a ck tr e a tm e n t r e d u ce s a n h ibi ti on i n kneee xte n so r m u scle s: a r a n d o m ize d co ntrol l ed tri al .,/
Manipulative Physiol Ther. 2000;23(2):76-80.
6 5 . T a ylo r DC, Da lto n JD, Jr ., Se a b e rAV Garrett WE , i r.
V isco e la sticp r o p e r tie s o f m u scle - te ndonuni ts. The
b io m e ch a n ica fe ffe ctso f str e tch in q .Am J S portsMed.
19 9 0 ;18 ( 3 ) :3 0 0 3 0 9 .
6 6 . T ha ch u k C, lr r g a n gJi, Sta r z T W. Re sponsi veness
of a
s pe cific m e a su r e o f p h ysica l fu n ctio n of the knee as
c om p a r e dto a g e n e r a lm e a su T eo f h e a l th status.A medcan College of Rheumatology,62nd National Meeting.
S a n Die g o , CA; 1 9 9 8 .
6l
6B
69.
10
11
12
13
14
Thomee R . A comprehensi vetreatment approach for
patel l ofemoralpai n syndrome i n young w omen. Phy s
Ther.1991:17(14:1690 1703.
ThomeeR , A ugustssonJ, K arl ssonJ. P atel l ofemoral
pai n
syndrome: a review of current issues. Sporfs Med.
1999:28Q):245-262.
Ti mm K E . R andomi zedcontrol l ed tri al of P rotoni cson
patel l ar pai n, posi ti on, and functi on. Med S ci S ports
fxerc. 1998;30(5):665670.
van Tul der MW, A ssendel ftWl , K oes B W. B outer L M.
Method gui del i nes for systemati c revi ew s i n t he
C ochraneC ol l aborati onB ack R evi ew Group for S pi nal
D isorders.Sp i ne. 1997:22(20):2323-2330.
V erhagenA P , de V et H C , de B i e R A , K essel sA G, B oers
M, K ni pschi l d P G. B al neotherapyand qual i ty ass es s
ment: i nterobserverrel i abi l i ty of the Maastri chtcri teri a
l i st and the need for bl i nded qual i ty assessment.
J C/l n
E pi demi ot.1998;51(4):335-341.
Werner S . A n eval uati on of knee extensorand knee
fl exor torquesand E MGs i n pati entsw i th patel l ofem oral
pai n syndrome i n compari son w i th matched control s .
Knee Surg Sports TraumatolArthrosc. 1995;3(2):8994.
Wi tvrouw E , Lysens R , B el l emans J, C ambi er D ,
V anderstraeten
G. Intri nsi cri sk factorsfor the devel opment of anteri orknee pai n i n an athl eti cpopul ati on .A
tw o-year prospecti ve study. A m I S ports Me d.
2000;28(4):480-489.
Wi tvrouw E , Lysens R , B el l emans J, P eers K ,
V anderstraetenG. Open versus cl osed ki neti c chai n
exerci sesfor patel l ofemoralpai n. A prospecti ve,ran
domi zed study.A m .l S portsMed. 2000;28(5):687- 694.
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