Effects of Wedged Insoles on Knee Osteoarthritis
Osteoarthritis is one of the most incapacitating diseases
affecting older populations. Greater than ten percent of people age
65 and over suffer from pain, functional limitations, and
reduced quality of life because of knee osteoarthritis.
The medial compartment of the knee is affected ten times
more often than the lateral (1). Though knee osteoarthritis is very
significant in the elderly, it is not inevitable with age.
Osteoarthritis is believed to be caused by knee mechanics
during gait. Throughout normal gait knees exhibit medial and
lateral thrust patterns. These thrust patterns of the knee
are limited by the LCL and MCL respectively but produce
increased loading at the opposite joint compartment. The
lateral structures of the knee oppose lateral thrust of the
knee, causing a varus moment and loading the medial joint
surface damaging articular cartilage (17). The varus moment
during normal gait is nearly 2.5 times that of the valgus
force. In knees with varus deformity the same ratio is
increased to 3.3 (11). Surgical procedures such as high
tibial osteotomy and total knee arthroplasty have been
effectively employed to treat medial knee OA, though these
procedures are costly and incur significant risk for
complications. Early investigators hypothesized that fitting
patients with laterally-wedged insoles would create
significant differences in static and dynamic torques at the
knee both through a change in tibiofemoral angle (19) as
well as a change in whole limb angle with respect to gravity
(15).
Analysis of normal gait cycle shows knee varus torque peaks
twice. The greatest varus torque occurs at the transition
through terminal stance and pre-swing. The second peak
occurs during weight acceptance. Crenshaw (2) was one of the
first researchers to demonstrate significant reduction in
peak varus torques with the use of laterally-wedged insoles
in symptomatic patients with osteoarthritis. The magnitude
of literature available demonstrates not only biomechanical
significance but also reduction in symptoms and improvement
of function with the use of wedged insoles. This research
touts that fitting patients with wedged insoles is a
cost-effective and minimally invasive procedure, which
consumes very little time for a physical therapist to
administer.
The Osteoarthritis Research Society International (OARSI), a
multidisciplinary team of sixteen experts from two
continents and six countries, devised 54 treatment
recommendations for knee OA based on sound scientific
judgment including a thorough review of the literature. The
first 11 recommendations fall under the scope of practice of
a physical therapist with recommendation number 4
specifically describing a referral to physical therapy for
evaluation and treatment. While experts carefully worded all
other recommendations to include suggestions where patients
“…might benefit from…” or “…may reduce symptoms with…” A
strongly worded recommendation number 9 states “Every
patient with hip or knee OA should receive advice concerning
appropriate footwear.” Experts go on to concur with the
literature that laterally-wedged insoles may be of benefit
to many patients with knee osteoarthritis (22).
Researchers agree that the use of wedged insoles is most
beneficial to patients with mild OA of the knee. All found
some benefit to patients with Kellgren & Lawrence grades of
II or less (18, 21) and one study showed improvement in
patients with moderate (K-L level III) disease severity
(11). When patients with symptomatic OA were compared to
healthy controls significant differences in the amount of
varus reduction was found. Healthier knees were consistently
found to have more dramatic biomechanical responses to
wedged insoles (5).
Researchers have found positive outcomes for patients with
the use of orthotics wedged anywhere from 4 degrees (which
corresponds to <5mm) all the way to 16mm inclinations to
determine which were most beneficial. Kerrigan et al first
described the correlation between increased angulation of
insoles and relief, but Fang and colleagues found that
within 4 weeks of use of simple 4 degrees shoe inserts
without subtalar strapping 10% of participants reported a
70% reduction of symptoms on the WOMAC subscales of pain,
stiffness, and function (7, 8, 9). Angulation of lateral
wedges produces a correlative reduction in knee varus
torque, however subjects randomized to 12mm and 16mm groups
had subsequent complaints of foot discomfort (20). Kakihana
et al found that the center of pressure of the foot which is
always parallel to the subtalar joint axis shifts laterally
with lateral wedge placement in most patients (5). Almost
exclusively researchers utilized a full length foot orthotic.
Investigators have recently capitalized on the previous
research for medial knee OA and produced data supporting the
use of medial-wedged insoles for the treatment of lateral
knee OA (14).
The current research is not without limitations. The most
proximal joints to the wedge are the subtalar joint at the
rearfoot and the 1st MTP at the forefoot. Several attempts
to construct a stabilizer for the subtalar joint have been
successful in further reducing the knee varus torque as
compared to simple wedging. In earlier studies, Toda et al
constructed a subtalar strapping technique then had to
revise it because of secondary complaints of pain or
discomfort from the strap (19). Through 6-month follow up,
Toda et al found that the participants did not continuously
use the insoles citing that the insoles required them to
wear shoes one size larger than they commonly wore (21).
Toda’s paper also represents the only long-term research to
date. At the same 6-month follow up nearly 1/4 of patients
elected to discontinue the study and forego the 2-year study
participation most complaining of inconvenience of the
inserts, very few reported no benefit of the treatment. Of
the 48 women who agreed to continuously use the insoles for
2 years, only those with strapped subtalar joints
demonstrated reduction of static tibiofemoral angle over
time as compared to those who wore simple inserted wedges.
Similarly, Toda’s research eludes to potiential prevention
of osteoarthritis progression via use of laterally-wedged
insoles with subtalar stabilization based on the Kellgren &
Lawerence grading scale (21). It should be noted that Toda
holds a patent for the design of the subtalar strapping
method. Rodriques and her team utilized an over the counter
sock-type ankle support to secure the orthotic to the foot
as well as stabilize the talus and found similarly
beneficial results in reduction of torques at the knee (14).
No research to date has addressed potential effects or
control for the 1st MTP, which is undeniably an important
generator in foot pain.
The research also lacks predictive variables to identify
which patients are most likely to benefit from wedged
insoles. A vast majority of patients in the research studies
benefited from laterally-wedged insoles for medial knee OA,
but a small portion of the patients in multiple research
studies had worsening of knee varus moments during gait with
use of these insoles (5).
A note of caution has been introduced by researchers Franz
et al in 2008 (4). It is becoming common to treat patients
symptomatically with medial-wedged or cushioned inserts for
common overuse injuries. In this study healthy recreational
runners were recruited to investigate changes in knee varus
torques with insoles. Not surprisingly, medial-wedged
insoles produced a 4% increase during running and 6%
increase during running. The authors caution that
symptomatic reduction for acute injuries may not outweigh
the damage caused by increased medial knee compression
forces with medial wedge inserts. The same authors cited
previous research demonstrating 23-26% increases varus
torque during wear of high-heeled shoes. Men and women have
no significant differences in knee torques during barefoot
walking, which suggests that extrinsic biomechanical
differences like footwear are to blame for the doubled
incidence of knee OA among women (9).
Future studies should examine possible predictive variables
to reduce the frequency of prescribing this intervention to
patients who’s condition may be worsened with wedged
insoles, investigate potential effects relative to 1st MTP
biomechanics, preventative use of insoles, and more long
term studies on footwear patterns as predictors in the
development of knee OA. As the tensile forces of ligaments
are directly implicated in providing opposite side joint
compression, researchers will also benefit to control for
varying degrees of ligamentous laxity or musculotendinous
flexibility. These soft tissue structures may restrict joint
motions even when the bony architecture is corrected.
In summary, laterally wedged insoles are an excellent
inexpensive treatment option for the treatment of knee
arthritis in conjunction with other therapeutic procedures
and appropriate patient education. Patients with mild to
moderate knee arthritis will likely benefit from wedged
insoles. Utilization of subtalar stabilization and
inclination of wedges as high as the patient can tolerate
without secondary foot pain is most beneficial. Clinical or
telephone follow up within 4-8 weeks of issue is essential
to determining the effectiveness of wedged insoles and as a
safety procedure to direct patients to stop the use of
insoles if they do not notice a reduction of symptoms at
that time. All therapeutic procedures carry side effects and
risk including administration of orthotics, exercise, and
education. Wedged orthotics for any condition should be
carefully supervised and re-evaluated so as to minimize
negative effects of their use. Imagine, nearly a year after your clinic opening, one
of your patients develops a superficial burn from a hot
pack!
Last revised: April 13, 2009
by
Jessica Johnson, MPT
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