1. For SEO
What is the Evidence for Prescribing Foot Orthoses?
This article discusses the available evidence for the efficacious use of custom-made foot
orthoses and is limited to custom-made products defined as “manufactured from raw materials
and molded over a three-dimensional (volumetric) cast of the foot, which captures bony
alignment and shape”.
Orthotic Efficacy
It is not uncommon for professors, professional association representatives and clinicians to
claim, “foot orthoses are an effective treatment for low back pain and a variety of other
musculoskeletal and postural complaints.”
In this era of evidence-based medicine, however, where conscientious care depends upon our
ability to make clinical decisions, which have been confirmed by sound scientific enquiry,
practitioners cannot make such claims about foot orthoses just yet.
Perhaps it is the empirical observation that patients “respond favorably” to foot orthoses that
has slowed the pursuit of hard evidence for the efficacy of custom-made foot orthoses.
Regardless, third party payors may soon require stronger evidence before letting the current
trend of increasing foot orthotic use continue.
Journals primarily for foot care professionals publish very few randomized clinical trials (RCTs).
A review of the podiatric literature arbitrarily choosing 1998 and 1993, found that a mere 1% of
the articles were RCTs. Instead of testing hypotheses, the majority of the articles generated
hypotheses. To compound the problem, those articles published in podiatric journals were of a
lesser quality than those published in mainstream medical journals. A Cochrane database
review (1997 to 2004), concerning the efficacy of foot orthoses, revealed only 6 RCTs. The
studies were deemed to be of variable quality according to the Consolidated Standards of
Reporting Trials (CONSORT-http://www.consort-statement.org/) guidelines with only one rating
as high as a Sackett’s grading of B – provides some support for clinical practice.
The range of research outcomes regarding orthotic efficacy varies from inconclusive to
supportive with one study suggesting that customs were inferior to off-the-shelf products. A
significant concern with research on custom-made foot orthoses, prior to the last few years, is
the absence of “subject-specific design” in those studies and the lack thereof being a confounder
of results. Without adequate research to provide an evidence-based platform, professionals vary
considerably in what they prescribe and it is difficult to develop guidelines for orthotic
prescriptions.
Four retrospective studies regarding custom-made foot orthoses, between 1985 and 1993,
revealed patient satisfaction ratings between 70% and 91%. A recent questionnaire of 275

2. patients indicated the majority felt that custom-made foot orthoses had provided relief of their
symptoms to a level of 60-100%. Criticisms of these studies however, include that they were
retrospective, did not control for other forms of treatment during the course of orthotic
therapy and were unclear in their classification of orthotic device. Furthermore, it has been
documented that “patient satisfaction” indicates service satisfaction and not necessarily
treatment outcome satisfaction.
The traditional notion that foot orthoses optimally align the skeleton is being critically
challenged by the scientific community as well. Repeated research efforts show that skeletal
movement changes due to foot orthoses are small, subject-specific and non-systematic.
Not All the News is Bad…
Replacing the traditional “re-aligning the skeleton” theory, are several plausible alternatives to
explain why custom-made foot orthoses seem to provide symptomatic relief of common
musculoskeletal (MSK) complaints:
• the biomechanical theory suggests that full contact orthoses, (whereby there is complete
orthotic-medial-arch contact) maximally control the pronatory moment (also described as
assisting midfoot re-supination) and allow for functional first ray plantarflexion in the
overpronating foot.
• The neuro-muscular theory for using full-contact custom-made orthoses suggests that the
medial and lateral arches of the foot are the most sensitive regions to changes in pressure and
vibration and that enhanced proprioceptive feedback allows for a movement pattern that
minimizes muscle activities. This accounts for the decrease in symptoms where kinetic changes
are minimal and unsystematic.
There is some research using these alternative theories, to indicate that full-contact custommade foot orthoses may decrease lower limb musculoskeletal symptoms within 4 weeks and
that there may be improvements in efficiency of gait by way of reducing centre of mass
oscillation. These results however are generalizable only to custom-made foot orthoses used in
that study. Another recent investigation using the same full-contact custom-made foot orthoses
compared them to a group wearing traditional custom-made foot orthoses. The EMED system
(a multi-sensor pressure mapping device) was used to assess changes in plantar pressure in the
two groups over a 6-week period. The researchers found that patients wearing the full-contact
orthoses more effectively approximated the ideal force curve, which included decreased
pressure over the lateral metatarsal head with increased pressure under the 1 st metatarsal
heads at toe-off.
What Can We Say?
There is some recent objective and subjective evidence in support of custom-made foot
orthoses for reducing MSK complaints and moving gait towards more idealized and efficient

3. patterns. There is however, not enough consistency in the research or volume of peer-reviewed
research to claim that all foot orthoses will resolve the variety of complaints seen in most
health care facilities. The responsibility rests with the individual practitioner to ensure that the
orthotic devices they recommend meet the criteria of custom-made and that claims of efficacy
are restricted to those within the mandate of evidence-based medicine.
Guidelines for the Conscientious Practitioner
As new research is published each month, it behooves clinicians to critically assess the quality
of that research before making statements regarding the efficacy of any treatment. Here are
some suggestions:
1. Ensure that the literature claiming orthotic efficacy is not promotional material distributed by
an orthotic manufacturing company. However, note that some orthotic companies do fund
research. If they do, look for a statement that they funded the study in the context of signing an
“arms-length agreement” which states that both positive and negative results will be published.
This is a risk most orthotics manufacturers are not willing to take and it is a good litmus test of
their product confidence. Ask if your company has funded “arms-length” research.
2. Ensure that the peer-reviewed literature is not being misquoted. I recently read a headline
within some marketing literature distributed by an orthotic company. The referenced literature
was indeed good work, however, the “revised” company headline completely misquoted the
author’s conclusions to imply an endorsement of their product.
3. Lastly, and probably most importantly, not all professional journals are stringently peerreviewed. Some function, more or less, as professional trades magazines. Unless the research is
published in a peer-reviewed journal be cautious of quoting any conclusions.
By the way, poster presentations at chiropractic conferences using underpowered sample sizes
and sponsored by orthotic companies are not consider peer-reviewed (recently a colleague
insisted that I must be incorrect about this). CONSORT provides an excellent 22-point checklist
for practitioners to judge the quality of any research. (http://www.consortstatement.org/?o=1011)
Good luck, happy practicing and remember;
“Education is a progressive discovery of our own ignorance.”
Leslie Trotter, BSc, MBA, CPed(C), MSc
- Will Durant

4. Visit www.theorthoticexpert.com for more information about Orthoses and Foot
Doctors in Ancaster, Ontario CA. If you need an Ancaster Orthotic Expert in
Ontario CA, visit www.FootKneeBack.com
Other articles you will find interesting:
What is the Evidence for Using Foot Orthoses
Do You Know The Real Cost of “Free” Shoes?