The Effectiveness of Prefabricated Foot Orthoses Compared to

William Wong, DPTc
UCSF/SFSU Graduate Program in Physical Therapy
http://www.webmd.com/a-to-z-guides/plantar-fascia-bottom-view
Bodyweight
http://ayrespodiatry.com
GRF
GRF
•A truss or triangular structure (Hicks, 1954)
•Plantar fascia acts as tie-rod, prevent MLA collapse (Bolga
and Malone, 2004)

Clinical diagnosis, no gold standard test (Wearing et al, 2005)
Heel pain (sharp or ache) with initial
steps in morning or after prolonged
inactivity (Aldridge, 2004)
http://krames.sjmctx.com/
Tenderness at plantar fascia at
medial calcaneus (Rosenbaum et al, 2014)
Karagounis et al, 2011

~2 million/year, 10% life-time
incidence
(Martin, Davenport, et al 2014)
http://spira.com/

Healthcare burden: $192$376 million annually
(Tong and Furia, 2010)
http://s3.amazonaws.com


Mod. difficulty: work, hobbies, walk
High difficulty: running
(Riddle et al, 2004)
http://fitnessformommies.net/
Plantar “fasciitis”
implies
inflammatory
condition
Histological studies
Plantar
suggest
“fasciopathy” or
degenerative plantar heel pain
changes (Beeson et al, 2014)
↓ankle
dorsiflexion
(<0°)
BMI >25 kg/m2
(Riddle et al, 2003)
http://www.plantar-fasciitis-elrofeet.com/
(Riddle et al, 2003)
Majority of
workday
standing
(Riddle et al, 2003)
Excessive foot
pronation
(Irving et al, 2007; Karas and
Hoy, 2002)
↑stress on plantar
fascia, pain
(Fuller 2000)
Address contributing factors, but also
decrease pronation and support the MLA
73-82% improve with conservative treatment; otherwise
surgery after 6 months (Rosenbaum et al, 2014)
Strong evidence for:
•Anti-pronation taping
•Night splints
•Manual therapy
•Stretching of calf or plantar
fascia
•Foot orthoses (Martin et al, 2014)
Indication for foot orthoses:
•anti-pronation taping yields symptom relief for the patient
(Meier et al 2008)
•excessive foot pronation (Martin et al 2014)
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Custom foot orthoses (CFO)
http://azwanderings.com/
Prefabricated foot orthoses (PFO)
Construction
Mold of foot in subtalar joint
(STJ) neutral for optimal
alignment (Lee, Lee, et al, 2012)
Material
Firmer: ethyl vinyl acetate (EVA),
Firmer: ethyl vinyl acetate (EVA), polyethylene, and polypropylene
polyethylene, and polypropylene
Softer: rubber, felt, silicone
Premade and sold according to
shoe size
lermagazine.com
thesportsphysio.wordpress.com
Custom foot orthoses (CFO)
Mechanism of
action
Access
Costs
http://azwanderings.com/
Prefabricated foot orthoses (PFO)
Support MLA, ↓stress on
plantar fascia
Support MLA, ↓stress on plantar
fascia
Requires specialist such as
podiatrist + time for
manufacturing process
Can be purchased from retail
stores or online
(Kogler, Solomonidis, et al 1996)
$200-$800 (Tuff, 2006)
(Escalona-Marfil 2014)
$30-$40 (Braff, 2011)
Plantar fasciopathy: most common foot
pathology seen by PTs
http://spira.com/
CFOs significantly more expensive than
PFOs
background-pictures.picphotos.net
PTs need guidance: PFOs or CFOs?
www.useoftechnology.com
Purpose: Assess whether CFOs or PFOs
are more effective
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and if…
• Supporting MLA
• CFOs should be
reduces stress on
more effective than
•
CFOs
made
from
plantar fascia
PFOs at treating
however…
patient-specific
STJcaused by excessive
patients with
neutral
positions
prontation
plantar fasciopathy
• PFOs have
similar
provide
more
plantaroptimal
pressure
alignment Inconsistencies regarding
distribution
theoretical superiority
of
If…
then
compared to CFOs
CFOs
(Redmond et al, 2009)
2011 Meta-analysis: CFOs improves pain and function (Uden et al, 2011)
2006 Meta-analysis: PFOs = CFOs at improving pain (Landorf et al, 2006)
2 new RCTs comparing CFOs
+ PFOs since 2006
No meta-analysis comparing
CFOs + PFOs for function
Gap: Updated meta-analysis using pain and function
as outcomes for comparing CFOs to PFOs
Function
• Outcomes measures:
• Foot Function Index (FFI)
• Foot Health Status Questionnaire (FHSQ)
(Budiman et al, 1991)
(Bennet et al, 1998)
• Functional limitations, may include pain
Pain
• Visual Analog Scale (VAS)
• Subscale of outcome measures
• Ex: FFI pain subscale
(Flandry et al, 1991)

Are CFOs more effective than PFOs?
Population
Intervention
• CFOs
Comparison
• PFOs
Outcome

• Subjects with plantar fasciopathy
• Pain, function
Motivation: Enable PTs to make evidencebased recommendations to patients
H0
• CFOs are not more effective than PFOs at improving
pain and function in patients with plantar
fasciopathy
Ha
• CFOs are more effective than PFOs at improving
pain and function in patients with plantar
fasciopathy
• 4-8 randomized controlled trials (RCTs)
Expected
findings • CFOs not more effective, since PFOs have similar
plantar pressure distribution (Redmond et al, 2009)
Inclusion
• Subjects with plantar fasciopathy
• Compare CFOs and PFOs
• RCTs
Exclusion
• Use of corticosteroid injections
Databases
• Pubmed, CINAHL, PEDro
Search
terms
• Alone or in combination: plantar heel pain, plantar
fasciopathy, prefabricate*, over the counter,
bespoke, custom foot orthoses, customized
Data
extraction
• Means and SDseffect sizesgrand effect sizes
• 95% confidence interval (Hedges et al, 1989)
Analysis
• Within-group, between-group
• Z-statistic for test of difference when appropriate
(Matthews and Altman, 1996)
Homogeneity
Weighting
• Q statistic
• Random effects model (p<0.05) (Borenstein et al, 2007)
• Fixed effect model (p>0.05)
• Inverse variance
Study
Level of
evidence
# subjects
Duration
Duration of
symptoms (months)
Ring and Otter,
2014
RCT, 2B
69
8 weeks
Not reported
Baldassin et al,
2009
RCT, 2B
142
8 weeks
17.9 + 25.6
Landorf et al,
2006
RCT, 1B
135
12 months
Median: 12 (1-360)
Martin et al,
2001
RCT, 2B
255
12 weeks
Median: 18
Pfeffer et al,
1999
RCT, 2B
236
8 weeks
most were <6
Study
Outcomes
reported
Ring and
Otter,
2014
Function
Baldassin
Pain,
et al, 2009 Function
Landorf et
Pain,
al, 2006 Function
Martin et
al, 2001
Pain
Pfeffer et
al, 1999
Pain
Significant for
pain?
CFO
PFO
Significant for
function?
CFO
PFO
Significant difference
between CFO and PFO?
CFOs within-group for pain
Statistically
significant
PFOs within-group for pain
Statistically
significant
Unfavorable Favorable
• Insignificant heterogeneity
• Fixed effects model
Unfavorable Favorable
• Insignificant heterogeneity
• Fixed effects model
CFOs vs. PFOs between-group for pain
Not significant
-0.26<(1.30-1.27)<0.32
Favors PFOs
Favors CFOs
CFOs within-group for function
Statistically
significant
Unfavorable Favorable
PFOs within-group for function
Statistically
significant
Unfavorable Favorable
• Significant heterogeneity
• Significant heterogeneity
• Random effects model
• Random effects model
•Q=8.26 (p=0.02)
•Q=19.28 (p=6.52x10-5)
CFOs vs. PFOs between-group for function
Not significant
Favors CFOs
• Insignificant heterogeneity
• Fixed effects model
Favors PFOs



No adverse effects reported across all 5
studies
Systematic review of 8 studies found
discomfort to be main adverse effect, leading
to discontinuing use (Collins et al, 2007)
Ring et al: comfort + overall satisfaction
 No difference between CFOs and PFOs
Study
CFO cost
PFO cost
Ring and Otter, 2014
£24.6 ($37.20)
£13.15 ($19.89)
Baldassin et al, 2009
100%
50%
Landorf et al, 2006
$225-$300
$45-$90
Martin et al, 2001
not stated
not stated
Pfeffer et al, 1999
$300
$8-$40

CFOs generally more expensive than PFOs
H0
• CFOs are not more effective than PFOs at improving
pain and function in patients with plantar
fasciopathy
Ha
• CFOs are more effective than PFOs at improving
pain and function in patients with plantar
fasciopathy

Evidence suggests that CFOs and PFOs equally effective!
Between-group analysis
Clinical units
Measure
MCID
Pain
0.7
FHSQ pain
13*
Function
0.5
MFPDQ
-

*only for within-group, not between group (Landorf et al, 2010)

Both <1 point, unlikely to be clinically significant
Similar
mechanism
of action
• Both shown to support MLA (Kogler, et al 1996; Escalona-Marfil 2014)
• Similar plantar pressure distribution (Redmond et al, 2009)
STJ-neutral •Perhaps
importance
ofposition
STJ-neutral
Resting stance
calcaneal
is 4° everted
in
relative to STJ-neutral
in healthy
individuals
overstated,
not necessary
for creating
(Sell
et
al,
1994)
standing?
www.scielo.br
STJ-neutral
during
gait?
cassiersbitanime.blogspot.com
foot orthosis
• Resting stance calcaneal position, not STJneutral, is neutral position during stance phase
(McPoil and Cornwall, 1994)
Ring
Baldassin
Landorf
Martin
Pfeffer
Random allocation
-
+
+
+
+
Concealed allocation
-
+
+
-
-
Baseline comparability
-
+
+
+
+
Blinding of subjects
-
+
+
-
-
Blinding of therapists
-
+
-
-
-
Blinding of assessors
+
-
-
-
-
Adequate follow-up
+
-
+
-
-
Intention-to-treat analysis
+
+
+
+
+
Between-group comparisons
Point estimates and variability
+
+
+
+
+
+
+
+
-
+
Total score (x/10)
5
8
8
4
5
PEDro criteria

CFO creation in studies may differ from clinical
practice
 Only 1 study explicitly stated who performed molding
(podiatrist)
 Vary density/thickness depending on bodyweight (Payne, 2013)

Specific PFOs used in studies not readily accessible
 Top 5 on Amazon.com: Dr. Scholl’s, Superfeet
 Popular commercially available PFOs not examined

Only 1 study with long-term follow-up (12 months)
 No difference among PFO, CFO, and sham orthoses!

Plantar fasciopathy is self-limiting
 Resolution of symptoms 6-18 months without treatment
(Roxas, 2005)
Study
Duration of symptoms (months)
Ring and Otter, 2014
Not reported
Baldassin et al, 2009
17.9 + 25.6
Landorf et al, 2006
Median: 12 (1-360)
Martin et al, 2001
Median: 18
Pfeffer et al, 1999
most were <6

Assess effectiveness of popular commercially
available PFOs

More rigorous methodology in creation of CFOs to
mimic clinical practice in RCTs

Assess effectiveness of PFOs/CFOs in conjunction
with other evidence-based treatment modalities
 Extend window of effectiveness beyond 3 months?

PTs should consider use of PFOs over CFOs for more
cost-effective treatment for patients with plantar
fasciopathy who have excessive pronation

PFOs should be comfortable and have MLA support

PFOs should be used in conjunction with other
modalities with strong evidence:
 Manual therapy, stretching

Address other contributing factors
 LE alignment: hip, knee
 Obesity, ↓DF, standing too much

Evidence suggests that CFOs are no more
effective than PFOs at improving pain and
function for patients with plantar fasciopathy

When indicated, PTs should consider the use
of PFOs over CFOs as they represent a more
cost-effective treatment option
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Diane Allen, PT, PhD
Andrew Lui, PT, DPT
Jean-Pierre Viel, DPT, OCS
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Felipe Cazares, DPTc
Matthew Rickerts, DPTc
Surn-Lee Yek, DPTc
Katie Nguyen, PharmDc
UCSF/SFSU Class of 2015
http://spectrumcenter.umich.edu/article/78
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Almost 3 years later…
Initial contact?
www.alexandrasports.com
Questions?
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