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STUDY PROTOCOL
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Keywords: Shin pain, Medial tibial stress syndrome,
Anti-pronation
Franettovich Smith et al. BMC Musculoskeletal Disorders 2014,
15:328http://www.biomedcentral.com/1471-2474/15/328for management
of ERLP are required.1School of Physiotherapy, Australian Catholic
University, Brisbane, AustraliaFull list of author information is
available at the end of the articleBackgroundExercise related leg
pain (ERLP) is a lower limb overuseinjury characterised by pain
located between the knee andankle that occurs during activity. The
condition encom-passes the clinical and pathological features of
severalcommonly used labels such as shin splints, medial
tibialstress syndrome, periostitis, stress fractures,
tendinopa-thies and compartment syndrome [1]. ERLP is particu-larly
common in running populations with 13 to 20% of
running injuries presenting to sports medicine clinicsattributed
to ERLP [1]. Incidence of ERLP has also beenreported to be higher
in females than males [2-6].Significant burden is associated with
the condition with40-60% of runners reporting that ERLP caused a
reduc-tion in running or an interruption to training
[7,8].Furthermore, the condition is associated with lengthyrecovery
periods in both runners and military personnel[9,10]. Given the
high incidence of the condition, subse-quent interference with
participation in physical activityand substantial recovery time,
effective interventions* Correspondence:
[email protected]
Background: Exercise related leg pain (ERLP) is a common lower
limb overuse injury characterised by pain locatedbetween the knee
and ankle that occurs during activity. The high incidence of the
condition, subsequent interferencewith participation in physical
activity and substantial recovery time, highlights a need for
effective interventions. Whilstmany interventions have been
described for the management of ERLP, currently there is a lack of
high quality evidencefor an effective intervention for the
condition.
Methods/Design: A single-blinded randomised controlled clinical
trial will be conducted in a community setting.Forty-five female
volunteers aged between 18 and 40 years with a history of insidious
onset of pain located betweenthe knee and ankle of at least one
month duration that is aggravated by weight bearing activities will
be recruited forthe study. Suitable participants will be randomly
allocated to one of three treatment groups for the 6 week
interventionperiod: (i) exercise only, (ii) rigid anti-pronation
tape and exercise, (iii) elastic anti-pronation tape and exercise.
Outcomeswill be measured at baseline, 1, 2 and 6 weeks using
primary outcome measures of usual and worst pain visualanalogue
scale and global perceived improvement. Secondary outcome measures
will include Foot and Ankle AbilityMeasure, Patient Specific
Functional Scale and amount of activity in the previous week. In
addition, participants will becontacted by phone to obtain primary
and secondary outcome measures at 12, 18, 24 and 30 weeks.
Discussion: This article describes a single-blinded randomised
controlled clinical trial that will utilise high
qualitymethodologies in accordance with CONSORT guidelines. The
results of this study will contribute to the limitedknowledge
regarding effective interventions for the management of ERLP.
Trial registration: Australian New Zealand Clinical Trials
Registry (ACTRN12613000914763)A comparison of rigid taptape and
exercise and exlower limb function in inrelated leg pain: a
randomMelinda M Franettovich Smith1*, Sonia S Coates1 and Ma 2014
Franettovich Smith et al.; licensee BioMthe Creative Commons
Attribution License (htdistribution, and reproduction in any
mediumDomain Dedication waiver (http://creativecomarticle, unless
otherwise stated.Open Access
e and exercise, elasticrcise alone on pain andividuals with
exerciseised controlled trial
W Creaby2ed Central Ltd. This is an Open Access article
distributed under the terms
oftp://creativecommons.org/licenses/by/4.0), which permits
unrestricted use,, provided the original work is properly credited.
The Creative Commons Publicmons.org/publicdomain/zero/1.0/) applies
to the data made available in this
-
Franettovich Smith et al. BMC Musculoskeletal Disorders 2014,
15:328 Page 2 of
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interventions have been described for themanagement of ERLP such as
load management, low-energy laser treatment, stretching exercises,
strengthen-ing exercises, compression stockings, leg braces,
pulsedelectromagnetic fields, ice massage, ultrasound,
ionto-phoresis, phonophoresis, and extracorporeal shockwavetherapy.
Whilst many of these interventions have beeninvestigated in the
literature, a recent systematic review[11] has reported a lack of
evidence for an effective inter-vention for the condition. Despite
the lack of researchevidence, there appears to be consensus among
clinicalopinion pieces and review articles for the use of
relativerest (load modification, alternative training), NSAIDS
andice in the acute phase of ERLP [1], and following this,
thecommencement of strengthening exercises for the calf
andintrinsic foot muscles as well as more proximal musclesincluding
the abdominals and gluteals with the aim ofimproving endurance and
running mechanics [1,12,13].To further develop the evidence base
from expert opinionand anecdotal reports, Winters and colleagues
[11] havesuggested that it may be important to first understand
theaetiological factors contributing to the condition.A systematic
review and meta-analysis by Newman
et al. [14] suggests that the aetiology of ERLP is
likelymultifactorial. The authors reported evidence forseveral
contributing factors: previous history of the condi-tion (relative
risk (RR) 3.74), female gender (RR 1.71),decreased running
experience (standardised mean dif-ference (SMD) -0.74), higher body
mass index (SMD0.24), history of orthotic use (RR 2.31) and >10
mmvertical displacement of the navicular from a subtalarneutral
position to bodyweight supported stance (RR 1.99),commonly termed
navicular drop [15]. Of these factorshowever only body mass index
and navicular drop arepotentially modifiable. Based on these
findings, it isconceivable that interventions which reduce body
massindex or reduce navicular drop may have the potentialto
influence pain and function in individuals with ERLP.Navicular drop
provides an indication of the vertical
mobility of the midfoot, which can also be measured bydorsal
arch height difference [15]. Interventions whichhave demonstrated
effectiveness in reducing verticalmobility of the midfoot include
taping and exercise.Anti-pronation taping techniques, such as the
low-Dyeand augmented low-Dye (ALD), have consistently dem-onstrated
reductions in vertical mobility of the midfootand increased medial
longitudinal arch height immedi-ately following application, during
walking and jogging,and following 20mins of jogging [16,17]. Of
interest, theALD taping technique has also demonstrated
maintenanceof an increase in medial longitudinal arch height
followingremoval of tape after two weeks of continual wear
[18].
Importantly, these biomechanical effects have beendemonstrated
in ERLP populations [17-19], howeverthe efficacy of the ALD in the
management of pain andfunction has not been evaluated. These
anti-pronationtaping techniques have traditionally in the past
beenapplied using a rigid (inelastic) sports tape, however inrecent
times, and at least since the 2008 OlympicGames, there has been
increasing popularity in the useof elastic tapes, such as Kinesio
tape , Dynamic Tape,KT-Tape, SpiderTech and Cure Tape [20]. The
rea-sons underlying the increasing popularity of elastictaping are
not known. The elastic nature of the tapeand alternate fabrication
with more waterproof mate-rials may lead to increased comfort. It
is also conceiv-able that the elastic recoil in the tape may
providemechanical assistance or resistance (deceleration
oracceleration) to movement, therein reducing the loaddemands on
musculotendinous units while also per-mitting full range of motion
to occur. Neverthelessdespite their growing utility in the clinical
setting, nostudy to date has evaluated the efficacy of an
elastictaping technique in the management of ERLP.Plantar intrinsic
foot muscle training consisting of sub-
maximal flexion of the metatarsophalangeal and
proximalinterphalangeal joints to raise medial longitudinal
archheight has also demonstrated reductions in verticalmidfoot
mobility. Mulligan et al. [21] reported that afour week program
consisting of three minutes daily ofthis plantar intrinsic foot
muscle exercise, which pro-gressed from sitting to bilateral and
single leg stance,produced a reduction in navicular drop. This
reductionin navicular drop was evident at conclusion of the
pro-gram and was maintained another four weeks followingcessation
of the program. This training program, how-ever, was evaluated in
an asymptomatic population andhas not been investigated in
individuals with ERLP. Inaddition, there is evidence that during
functional tasksmotion of the foot is related to more proximal
motionat the hip, suggesting that a whole limb approach tocontrol
midfoot mobility may be warranted. Specifically,increased navicular
drop has been reported to be relatedto increased hip internal
rotation during a single-legsquat [22] and moderate to strong
correlations havebeen reported between frontal and transverse
planemovements of the hip and frontal plane movement ofthe foot
during walking [23,24]. This evidence suggeststhat strengthening
exercises for the hip abductor andexternal rotator muscles may also
have the potential toinfluence foot mobility, however this has not
beeninvestigated.The current lack of evidence for effective
interventions
for the management of ERLP warrants the conduct offurther high
quality randomised controlled trials. A rea-sonable rationale for
the development of an effective
intervention may be one based on current clinical expertopinion
and addressing identified risk factors for the
-
Recruitment of participantsFemale volunteers will be recruited
from paid advertise-ments in local community newspapers,
supplementedby regular postings of advertisements on
noticeboardswithin the University and wider community (e.g.
gym-nasiums, sporting clubs, health clinics). Each
potentialparticipant who responds to advertisements will undergoa
screening process (via phone or email) to determineeligibility.
Eligible volunteers will be provided with aninformation sheet
thoroughly explaining the study andinformed written consent to
participate in the study willbe obtained. Once eligibility has been
determined and theinformed consent process completed, participants
will beassigned an identification number. Enrolled participantswill
attend a baseline testing session at which an assessorblinded to
group allocation will obtain demographic infor-mation (age, weight,
height), clinical characteristics ofERLP (nature, location,
duration, onset, previous treat-ment), exercise history (intensity,
duration and modalityof current participation, and participation
prior to the
Figure 1 Flow chart of participants through study.
Franettovich Smith et al. BMC Musculoskeletal Disorders 2014,
15:328 Page 3 of
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previously discussed, there appears to be ageneral consensus that
advocates relative rest followedby strengthening exercise(s) for
the management ofERLP. Whilst several risk factors for the
condition havebeen identified, foot mobility is one of two
modifiablefactors. Anti-pronation taping and plantar intrinsic
footmuscle training have demonstrated the ability to reducefoot
mobility, however, no scientific study has evaluatedthe
effectiveness of either intervention in the manage-ment of pain and
function in ERLP.
MethodsAimThe aim of this project is to compare the
effectivenessof (i) lower limb muscle training alone, (ii) lower
limbmuscle training and rigid anti-pronation taping, and (iii)lower
limb muscle training and elastic anti-pronationtaping, for the
management of ERLP.
Study designA randomised controlled clinical trial will be
conductedin a community setting over a 12 month period.
TheAustralian Catholic University Human Research EthicsCommittee
has granted ethical approval and all partici-pants will provide
informed written consent prior tocommencement in the trial. An
individual independentto the trial will perform the
computer-generated ran-domisation sequence and preparation of
envelopes con-taining the group allocation. The physiotherapist
willcommunicate with participants regarding group alloca-tion; due
to the nature of the intervention it will not bepossible to blind
the treating physiotherapist or the par-ticipants. An assessor
blinded to group allocation willperform outcome measurements at all
time points. Dataentry and statistical analysis will be performed
by ablinded assessor. Figure 1 provides an overview of thestudy
protocol.
Eligibility criteriaFemale volunteers will be eligible for
participation in thetrial on the basis of the following criteria:
age 18 to40 years, insidious onset of pain unrelated to any
trau-matic event, pain located between the knee and ankle ofat
least one month duration that is aggravated by weightbearing
activities such as running, hopping or jumping,and worst pain over
the previous week of at least 30 mmon a 100 mm visual analogue
scale. Volunteers will beexcluded from the trial in the presence of
any of the fol-lowing: a history of surgery to the lower limb, a
cardiaccondition, a known allergy to adhesive strapping tape,or
symptoms of radiculopathy or other neurological in-volvement.
Extensive previous exposure to either taping
technique will also exclude volunteers from participationin
order to prevent bias to one intervention.onset of ERLP), and
perform outcome measurements.At the conclusion of baseline outcome
measurements,
-
Franettovich Smith et al. BMC Musculoskeletal Disorders 2014,
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participant will be notified of group allocation bythe treating
physiotherapist and the intervention willcommence.
RandomisationFor group allocation, a computer-generated table
ofrandom numbers (in three blocks) will be used for
therandomisation sequence. An individual not otherwiseinvolved in
the study will place the randomisationsequence in a series of
consecutively numbered opaqueenvelopes, and sign across the seal of
the envelope.Allocation will be concealed from the outcome
assessorfor the duration of the trial.
InterventionThe interventions will be performed by one of two
regis-tered physiotherapists (Physiotherapy Board of
Australia),each with at least 10 years of experience in
musculoskel-etal physiotherapy. In addition, both physiotherapists
willhave completed two comprehensive training sessionstogether for
explanation and discussion of the standar-dised intervention
protocol for the trial. A detailed writtenprotocol outlining trial
procedures will be provided totreating physiotherapists. This will
include standardisedinstructions for participant advice,
application of both therigid and elastic taping techniques,
prescription of thelower limb muscle training exercises, and
recording oftreatment. Over a six week intervention period
partici-pants will receive one of three treatments: (i) lower
limbmuscle training alone, (ii) combined intervention of rigidtape
and lower limb muscle training, (iii) combined inter-vention of
elastic tape and lower limb muscle training.
Lower limb muscle training aloneParticipants in this group will
receive advice and edu-cation and will be prescribed an exercise
program toperform at home. At the completion of the baseline
out-come measurements, the physiotherapist will provide
astandardised information sheet with advice and educa-tion
regarding ERLP, as well as load management. Partic-ipants will be
advised not to start any new activities ortreatments for the
duration of the study, encouraged tocontinue to wear current
footwear (including orthoticuse) and participate in activities that
do not provokesymptoms and to avoid activities that aggravate
symp-toms either during or following the activity; as
treatmentprogresses, this may include a return to participation
inactivities that previously aggravated symptoms.At the end of week
1, the participant will attend a
thirty minute physiotherapy session where advice andeducation
information will be reviewed with the patientand training in the
exercise program will commence.
The exercise program will include two exercises: (i) theplantar
intrinsic foot muscle exercise [21] (Figure 2), and(ii) hip
abductor and external rotator muscle exercise(Figure 3). The
difficulty of both exercises can be in-creased from
non-weightbearing, to double-limb weight-bearing and then
single-limb weightbearing (Figures 2and 3). A rating scale to
assess the intrinsic foot muscles[21], based on unsteadiness of
navicular height duringsingle-limb stance, will be used to decide
the difficultyof the exercises prescribed at the first session:
non-weightbearing exercises will be prescribed for a rating ofpoor
stability; double limb weightbearing exercises willbe prescribed
for a rating of fair stability, and single-limb weightbearing will
prescribed for a rating of goodstability. Participants will be
instructed how to performthe exercises at each level of difficulty,
and will beencouraged to increase the difficulty of the
exerciseswhen full repetitions are achieved (3 minutes for
intrin-sic foot muscles, 3 20 second holds for gluteal mus-cles).
Participants will be instructed to perform theexercises daily and
record the exercises they completedand their difficulty level in a
training diary for the dur-ation of week 2 of the trial. At the end
of week 2, theparticipant will attend a thirty minute
physiotherapysession to reinforce advice and education, review
theexercise program and progress exercises as able. Partici-pants
will be instructed to perform the exercises dailyand record the
exercises they completed and their diffi-culty level in a training
diary for a further 4 weeks. Tocheck exercise progression and
encourage compliance,the treating physiotherapist will contact
participantsweekly by telephone. At conclusion of the 6 week
inter-vention, participants will be encouraged to continue
pre-scribed exercises and load management strategies andthis self
management will be recorded in follow-up ques-tionnaires at 12, 18,
24 and 30 weeks.
Combined rigid anti-pronation taping and lower limbmuscle
trainingParticipants will receive advice and education, be
pre-scribed an exercise program and wear rigid ALD taping[25]
(Figure 4). At the completion of the baseline out-come
measurements, the physiotherapist will provide astandardised
information sheet, as described above. Fol-lowing this, ALD taping
will be applied using a rigidsports tape (38 mm zinc oxide
adhesive, LeukosportBDF) and the appropriate skin checks made and
warn-ings given. Participants will be re-taped half way throughweek
1; no advice or education regarding the exerciseswill occur during
this session. Participants will beinstructed to remove the tape and
any tape residue thenight prior to attending the testing session.
At the endof week 1, the participant will attend a thirty
minutephysiotherapy session where advice and education will
be reinforced, the ALD tape re-applied and training inthe
exercise program commenced. The exercise program
-
Figure 2 Plantar intrinsic foot muscle training. Plantar
intrinsic foot muscle training will be performed as described by
Mulligan et al. [21].Active intrinsic foot muscle exercises may be
commenced in a non-weight bearing sitting position (A). The patient
is instructed to increase themedial longitudinal arch by gently
supinating the foot and approximating the head of the first
metatarsal towards the heel, without flexing thetoes. This position
should be held for 5 seconds and then slowly released back to a
relaxed state. Patients should aim to perform up to 3 minutesof
this exercise daily. Exercises can then be progressed to functional
weight bearing positions, for example double-limb stance (B) and
single-limbstance (C). For further progression, a small knee bend
(D) and/or heel raise (E) can be added to these functional
positions.
Figure 3 Hip abductor and external rotator muscle training. For
the non-weight bearing and weight bearing exercises, the patient
will performa 20 second hold and aim to perform 3 repetitions,
daily. The non-weight bearing exercise (A) will be performed in
side-lying with the treatment limbuppermost and both limb flexed to
45 at the hip and 90 at the knee. Ideally the patients back and
plantar surface of the foot are placed against a wallfor control of
position and movement. The patient raises the top limb off the
other, such that the hip is in ~30 abduction/external rotation
beforereturning to the starting position. The weight bearing
exercise (B) is performed with the patient standing side-on to a
wall with body rotated slightlyto face into the wall. The leg
closest to the wall is flexed at the knee so that the foot is off
the ground, and the hip is in neutral flexion/extension. Thefoot of
the leg closest to the wall is tucked behind the knee of the outer
leg. The standing leg knee should be bent slightly. The patient is
instructed tosqueeze the bottom together and hold this throughout
the movement, then turn the knee of the standing leg out without
moving the foot or pelvis.The bent leg is held against the wall for
balance only.
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niqeewit
Franettovich Smith et al. BMC Musculoskeletal Disorders 2014,
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10http://www.biomedcentral.com/1471-2474/15/328Figure 4 Rigid
anti-pronation taping technique (ALD). The ALD techThe ALD
comprises of a low-Dye technique (A) with the addition of thrare
anchored to the lower third of the leg. The technique is
completedwill include the same two exercises as described above:(i)
intrinsic foot muscle exercise, and (ii) hip abductorand external
rotator muscle exercise. Participants will beinstructed to perform
the exercises daily and recordtheir performances in a training
diary for the duration ofweek 2 of the trial. Participants will be
re-taped half waythrough week 2; no advice or education regarding
theexercises will occur during this session. Participants willbe
instructed to remove the tape and any tape residuethe night prior
to attending the testing session. At theend of week 2, the
participant will attend a thirty minutephysiotherapy session to
reinforce advice and education,review the exercise program and
progress exercises asable. Participants will be instructed to
perform the exer-cises daily and record in a training diary for a
further4 weeks. To check progress and encourage compliance,the
treating physiotherapist will contact participantsweekly by
telephone. No taping will be applied duringthese final 4 weeks of
the intervention.
Elastic anti-pronation taping and lower limb
muscletrainingParticipants will receive advice and education, be
pre-scribed an exercise program and wear an elastic anti-pronation
taping [26] (Figure 5). At the completion of thebaseline outcome
measurements, the physiotherapist willprovide advice and education
regarding the condition and
the malleoli (D).ue will be applied following guidelines
previously described [25].reverse-6 techniques (B) and two
calcaneal sling techniques (C) thath circumferential lock off
strips from the proximal anchor to just aboveload management.
Following this, elastic anti-pronationtaping will be applied using
an elastic tape (50 mm &75 mm, Beige Dynamic Tape) and the
appropriate skinchecks made and warnings given. Participants will
bere-taped half way through week 1; no advice or educationregarding
the exercises will occur during this session. Par-ticipants will be
instructed to remove the tape and anytape residue the night prior
to attending the testing ses-sion. At the end of week 1, the
participant will attend athirty minute physiotherapy session where
advice andeducation will be reinforced, the elastic tape
re-appliedand training in the exercise program will commence.
Theexercise program will include the same two exercises asdescribed
above: (i) intrinsic foot muscle exercise, and (ii)hip abductor and
external rotator muscle exercise. Partici-pants will be instructed
to perform the exercises daily andrecord their performances in a
training diary for the dur-ation of week 2 of the trial.
Participants will be re-tapedhalf way through week 2; no advice or
education regardingthe exercises will occur during this session.
Participantswill be instructed to remove the tape and any tape
residuethe night prior to attending the testing session. At the
endof week 2, the participant will attend a thirty
minutephysiotherapy session to reinforce advice and
education,review the exercise program and progress exercises
asable. Participants will be instructed to perform the exer-cises
daily and record in a training diary for a further
-
Figure 5 Elastic anti-pronation taping technique. The
elasticanti-pronation taping technique will be applied following
Dynamic Tapeguidelines for the plantar fascia and anti-pronation
techniques [26]. Foreach technique a double layer of 50 mm Dynamic
Tape will be used.The plantar fascia technique (A) is applied by
cutting out a small wedgefrom one end of the double layered tape to
allow it to conformto the proximal phalanx of the first toe. With
the foot and ankle in fullplantarflexion, inversion, adduction and
flexion of the first toe, the tape isapplied from the plantar
surface of the first toe, along the medial plantaraspect of the
foot, onto the medial aspect of the calcaneus, around thecalcaneus
to cross the lateral aspect obliquely, continuing under theplantar
aspect of the foot to emerge under the navicular and finallylifting
the navicular to anchor the tape on the dorsum of the foot.The
anti-pronation technique (B) is then applied with the foot and
anklein full dorsiflexion, inversion, and adduction. The double
layered tape isapplied from the plantar surface of the foot between
the first and secondmetatarsals, courses over the dorsum of the
foot from medial to lateral,under the plantar aspect of the foot on
a diagonal course to the navicular,lifting the navicular and
coursing across the anterior talocural joint toanchor on the
lateral aspect of the mid-shin region. The anti-pronationtechnique
is then repeated with one layer of 75 mm Dynamic Tape (C).
Franettovich Smith et al. BMC Musculoskeletal Disorders 2014,
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weeks. To check progress and encourage compliance, thetreating
physiotherapist will contact participants weeklyby telephone. No
tape will be applied during these final4 weeks of the
intervention.
Outcome measurementsA blinded assessor will perform tests of
foot mobilityand other outcome measurements at baseline and then
atfollow-up sessions occurring at 1, 2, and 6 weeks. Partici-pants
will also be contacted by email or phone to obtainquestionnaire
outcome measurements only at 12, 18, 24and 30 weeks. At the
completion of the test sessions,assessor blinding will be evaluated
via a questionnaire.Biomechanical effectiveness of the intervention
will be
evaluated by measuring vertical mobility of the midfoot.These
measures will be performed at baseline and thenat follow-up
sessions occurring at 1, 2, and 6 weeks. Inaddition to these
measurements by the assessor, thetreating physiotherapist will also
obtain a measurementof foot mobility before and after each
application of tapeto ensure consistency of application of the
intervention.Measurement of vertical mobility of the midfoot will
beperformed using two custom made platforms and modi-fied callipers
with the participant in two positions (i)standing on both feet with
equal weightbearing and, (ii)sitting with legs relaxed over the
edge of a plinth. Dorsalarch height difference will be calculated
by subtractingthe dorsal arch height in standing from the dorsal
archheight in non-weight bearing. This measurement hasbeen
described in detail previously and demonstrateshigh inter- and
intra-rater reliability [15].
Visual Analogue ScaleUsual and worst pain over the preceding
week will beobtained using two separate 100 mm visual
analoguescales (VAS). The reliability and validity of the VAS
iswell established [27]. Each VAS will consist of a 100
mmhorizontal line with the text no pain at the 0 mm markand worst
pain imaginable at the 100 mm mark. Partici-pants will be
instructed to place a single vertical mark onthe horizontal line
that represents the level of their pain.
Foot and Ankle Ability MeasureFunction will be measured using
the Foot and AnkleAbility Measure (FAAM) which provides an
indicationof participation in usual activities [28]. The FAAM is
aset of eight (8) items that are each scored by the partici-pant
from 4 to 0, with a score of 4 indicating no diffi-culty with the
functional task and 0 indicating that theparticipant is unable to
perform the task. Thus, thegreater the FAAM score, the higher the
level of function.
The validity, reliability and responsiveness of the FAAMhas been
previously demonstrated [28].
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Functional ScaleThe Patient Specific Functional Scale (PSFS)
provides amethod for eliciting, measuring and recording
descrip-tions of patients disabilities that are most relevant
tothem. Participants will be asked to identify up to five
(5)important activities that they are having difficulty withor are
unable to perform. The current level of difficultyassociated with
each activity is then marked on an 11-point scale, where 0 is
unable to perform activity and10 is able to perform activity at the
same level as beforethe injury or problem. This scale has been
shown tohave excellent test-retest reliability, sensitivity to
change,and validity [29].
Global perceived effectGlobal perceived effect will be measured
with a 6-pointLikert scale with categories: completely recovered,
muchimproved, improved, no change, worse and much worse.Such
retrospective assessment scales have been shownto be more sensitive
to change and more correlated withpatients satisfaction with change
than serial assessmentscales that include a baseline measurement,
such as theVAS [30]. This outcome measure will be performed ateach
of the follow-up sessions, but not at baseline.
Amount of activity performed in the previous weekThe physical
activity level of participants will be quantifiedusing a physical
activity questionnaire which has previ-ously demonstrated moderate
to high reliability [31]. Theparticipant will record the amount of
time spent in occu-pational, household, and leisure activities of
moderate,hard and very hard intensities during the previous
week.The total time for each intensity level of activity is
thenmultiplied by the metabolic equivalents of the activitiesand
summed to give an overall caloric output. This canthen be
standardised to body weight to allow comparisonbetween and within
individuals over time.A further questionnaire regarding any adverse
re-
sponses and perception of comfort of the taping inter-ventions,
as well as whether participants have soughtany treatment outside
the study, will be administered atfollow-up sessions at 1, 2 and 6
weeks.
Sample size considerationsSample size calculations [32] indicate
that 10 partici-pants per group will be sufficient to detect (i) a
clinicallysignificant improvement of 20 mm in pain severity
[33]based on a standard deviation of 12.7 mm [34], power of0.80 and
alpha level 0.05 and (ii) a clinically significantimprovement of 9
points [28] on the FAAM based on astandard deviation of 26.7 [28],
power of 0.80 and alphalevel of 0.05. To account for potential
dropout, 15 par-
ticipants per group will be recruited, with a total samplesize
of 45.Planned statistical analysisData processing, data entry and
data analysis will be per-formed by an assessor who is blinded to
group alloca-tion. The primary analysis of the data will be
performedon an intention-to-treat basis. SPSS software
(version21.0) will be used for statistical procedures. Demo-graphic
data, clinical characteristics of pain and physicalactivity level
at baseline will be examined for compar-ability across the three
intervention groups. To evaluatethe effect of the interventions on
pain and function(VAS, FAAM, PSFS, Physical activity level) a
two-wayrepeated measure analysis of variance with betweensubject
factor of intervention group and within subjectfactor of test
session, will be performed. Global perceivedeffect will be
dichotomised to either success (completelyrecovered, much improved,
improved) or no success(no change, worse, much worse) and expressed
as rela-tive risk reduction and numbers needed to treat. For
allstatistical procedures age, weight and height will beincluded as
covariates and alpha level will be set at 0.05.
DiscussionThis study will be the first randomised controlled
trial toevaluate the effectiveness of anti-pronation taping
andlower limb muscle training for ERLP. As there is cur-rently a
lack of evidence for effective interventions forERLP [11], the
results of this study will provide evidenceto inform healthcare
providers in the management ofthe condition. For example, if this
study identifies oneintervention to be superior to the others, this
interven-tion can be recommended in preference to others.
Alter-natively, if no differences are identified between thethree
intervention groups, then taping would be consid-ered to have no
additional benefit over exercise aloneand it would therefore be
recommended that clinicianscould focus on exercise alone rather
than additionaltaping. An important feature of this study is the
inclusionof a follow-up at 12, 18, 24 and 30 weeks. Accordingly,
thisstudy will provide an evaluation of both the short and longterm
effectiveness of an intervention for ERLP.The three intervention
groups evaluated in this study
were selected to target a reported risk factor for the
condi-tion (increased foot mobility) as well as to reflect
clinicalpractice. Clinical opinion pieces and review articles
advo-cate the reduction of pain through relative rest
(loadmodification, alternative training), NSAIDS and ice in
theacute phase of ERLP, and following this, the commence-ment of
strengthening exercises [1,12,13]. Therefore, weselected a lower
limb muscle training intervention whichconsisted of advice and
education on ERLP and load man-agement, followed by strengthening
exercises. For com-parison, we included a combined intervention of
taping
and lower limb muscle training. This was selected toreflect a
tissue stress model approach to management
-
Franettovich Smith et al. BMC Musculoskeletal Disorders 2014,
15:328 Page 9 of
10http://www.biomedcentral.com/1471-2474/15/328whereby the short
term use of external devices (such astaping) is advocated to
alleviate tissue stress and thenfollowed by conventional physical
therapy modalities suchas muscle strengthening exercises
[35,36].The rigid anti-pronation taping technique (ALD)
selected
for this randomised controlled trial is a well-establishedand
described technique which has previously demon-strated
biomechanical effectiveness in ERLP populations. Astrength of this
randomised controlled trial is the inclusionof a comparative
elastic anti-pronation taping technique.Despite a rapid uptake of
these tapes clinically, there is lim-ited evidence as to their
biomechanical or clinical efficacy,and specifically, no study has
investigated an elastic tapingtechnique in an ERLP population. In
addition to evaluatingthe clinical efficacy of the rigid and
elastic anti-pronationtaping techniques, this study may also enable
somecomparisons to be made between them, including inci-dence of
adverse responses and perceptions of comfort.The lower limb muscle
training selected for this ran-
domised controlled trial includes two exercises; oneaimed at the
plantar intrinsic foot muscle and one aimedat the external rotator
and abductor muscles of the hip.Plantar intrinsic foot muscle
training was included inthis study as previous evidence has
reported effective-ness to influence vertical mobility of the
midfoot [21], afactor that has been prospectively identified as a
contrib-uting to the development of ERLP [14]. Whilst there isno
study to date that has investigated the use of hipexternal rotator
and abductor muscle training on footposture or mobility, there is
theoretical evidence thatsupports the rationale for its inclusion.
Aligning with akinetic chain approach to lower limb function,
frontaland transverse plane hip motion has been shown to bestrongly
correlated to frontal plane foot motion duringwalking [23,24], and
increased navicular drop has alsobeen shown to be related to
increased hip internal rota-tion during a single-leg squat [22].
This is supported bythe finding of altered proximal control of
gait, specific-ally the gluteus medius (abductor and external
rotator ofthe hip), in individuals with ERLP [34]. The
non-weightbearing hip rotation exercise was selected because it is
arelatively simpler task with less body segments to control.It is
also a commonly prescribed exercise for gluteus med-ius clinically
and previous fine-wire investigations havereported higher
gluteal-to-TFL muscle activation com-pared with other hip exercises
[37]. The weight bearingexercise progression was selected to
increase complexityand to facilitate relevance to the functional
tasks of walk-ing and running. Specifically it was chosen as it
closelyresembles the midstance position of these activities and
hasbeen used in previous studies to target gluteal strengtheningin
other lower limb overuse conditions [38,39].
This randomised controlled trial is registered with
the Australian New Zealand Clinical Trials
Registry(ACTRN12613000914763) and will comply with the CON-SORT
statement. Previous randomised controlled trials inERLP populations
have exhibited high risk of bias [11] andtherefore this study has
been designed with considerationto minimise these limitations.
Specifically this study designincorporates a random sequence
generation and concealedallocation to minimise selection bias,
blinding of the out-come assessor to group allocation to minimise
detectionbias and blinding of the investigators responsible for
dataprocessing and statistical analysis to minimise possible
biasassociated with their anticipated outcomes. Unfortunately,due
to the nature of the interventions, blinding of par-ticipants and
the treating physiotherapist to preventperformance bias is not
possible. Finally, to ensure highmethodological quality, outcome
measures with estab-lished reliability and validity have been
selected. A limi-tation of the methodology is the recruitment of
femaleparticipants of less than 40 years of age; therefore
theresults of this study may not be generalizable to male and/or
older populations with ERLP. This limitation, however,should be
considered in light of evidence that femalegender has been reported
as a risk factor in ERLP [14] andhigher incidence of ERLP has been
reported in bothfemales and the 1840 years age group [2-6,40].
AbbreviationsALD: Augmented low-Dye; ERLP: Exercise related leg
pain; FAAM: Foot andAnkle Ability Measure; PSFS: Patient Specific
Functional Scale; RR: Relative risk;SMD: Standardised mean
difference; VAS: Visual analogue scale.
Competing interestsThe authors declare that they have no
competing interests.
Authors contributionsMS conceived the trial and is chief
investigator on the research grants. MS, SOand MC planned and
designed the trial. MS was responsible for registering thetrial and
writing the manuscript. SO and MC edited and reviewed the
manuscript.All authors have read and approved the final
manuscript.
AcknowledgementsThis study is funded by an Australian Catholic
University Health FacultyResearch Grant and Australian Catholic
University Early Career ResearcherGrant.
Author details1School of Physiotherapy, Australian Catholic
University, Brisbane, Australia.2School of Exercise Science,
Australian Catholic University, Brisbane, Australia.
Received: 18 February 2014 Accepted: 19 September 2014Published:
2 October 2014
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doi:10.1186/1471-2474-15-328Cite this article as: Franettovich
Smith et al.: A comparison of rigid tapeand exercise, elastic tape
and exercise and exercise alone on pain andlower limb function in
individuals with exercise related leg pain: arandomised controlled
trial. BMC Musculoskeletal Disorders 2014 15:328.
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AbstractBackgroundMethods/DesignDiscussionTrial registration
BackgroundMethodsAimStudy designEligibility criteriaRecruitment
of participantsRandomisationInterventionLower limb muscle training
aloneCombined rigid anti-pronation taping and lower limb muscle
trainingElastic anti-pronation taping and lower limb muscle
training
Outcome measurementsVisual Analogue ScaleFoot and Ankle Ability
MeasurePatient Specific Functional ScaleGlobal perceived
effectAmount of activity performed in the previous week
Sample size considerationsPlanned statistical analysis
DiscussionAbbreviationsCompeting interestsAuthors
contributionsAcknowledgementsAuthor detailsReferences