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Journal of the Formosan Medical Association xxx (xxxx) xxx

Available online at www.sciencedirect.com

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journal homepage: www.jfma-online.com

Original Article

Comparison of the effect of Western-made

unloading knee brace with physical therapy
in Asian patients with medial compartment
knee osteoarthritisdA preliminary report
Lin-Fen Hsieh a,b, Yu-Ting Lin a, Chun-Ping Wang a,
Ya-Fang Liu c,d, Chien-Tsung Tsai e,*

a
Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei,
Taiwan
b
School of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan
c
Department of Education and Research, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan
d
School of Public Health, National Defense Medical Center, Taipei, Taiwan
e
Department of Physical Therapy and Rehabilitation, Da Chien General Hospital, Miao Li City, Taiwan

Received 18 January 2019; received in revised form 29 March 2019; accepted 27 May 2019

KEYWORDS Purpose: To compare the effect of unloading knee brace with physical therapy (PT) in Asian
Knee osteoarthritis; patients with osteoarthritis (OA) of the knee.
Knee brace; Method: This is a non-random, two-group comparative study. Patients with medial compart-
Therapeutic exercise; ment knee OA (n Z 41) were assigned to either the brace group (n Z 20) or PT group
Treatment (n Z 21). Patients in the brace group were fitted with an unloading knee brace for three
months and the PT group received a 60-min session of physiotherapy over the affected knee,
three times a week, for three months. The primary outcome measures were the pain visual
analogue scale (VAS) and the Western Ontario McMaster University Osteoarthritis Index (WO-
MAC); the second outcome measures were the 36-item Short-Form Health Survey (SF-36) and
patient’s satisfaction. The patients were evaluated at baseline, and at one month and three
months.
Results: Group comparison showed no significant difference regarding pain VAS, WOMAC, SF-
36, and patient’s satisfaction, except stiffness in WOMAC (P Z .006) and social functioning
in SF-36 (P Z .007). Time and group interaction revealed significant differences only in general
health (P Z .007) and mental health (P Z .006) of SF-36. Within-group comparison found that
pain VAS and WOMAC decreased significantly at one months and three months in both groups.

Abbreviation: PT, physical therapy; OA, osteoarthritis; VAS, visual analogue scale; WOMAC, Western Ontario McMaster University Osteo-
arthritis Index; NSAID, Nonsteroidal anti-inflammatory drugs; SF-36, 36-item Short-Form Health Survey.
* Corresponding author. Department of Physical Therapy and Rehabilitation, Da Chien General Hospital, No. 36, Gongjing Rd., Miaoli City,
Miaoli County, 360, Taiwan.
E-mail address: aEric.lai@gmail.com (C.-T. Tsai).

https://doi.org/10.1016/j.jfma.2019.05.024
0929-6646/Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an open access article under the CC
BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024
 + MODEL
2 L.-F. Hsieh et al.

Conclusion: The effect of brace fitting in patients with knee OA was similar to that of physical
therapy. A Western-made unloading knee brace is acceptable in some Asian people with knee
OA.
Clinical trial registration number: NCT02712710.
Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an
open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-
nc-nd/4.0/).

Introduction
Osteoarthritis (OA), or degenerative joint disease, is one of
the most common joint diseases globally. In the U.S.,
approximately 15.8 million people suffer from OA, and the
prevalence of OA in adults aged from 25 to 74 years old was
12.1%.1 Among those older than 26 years old in the U.S.,
approximately 4.9% had symptomatic osteoarthritis; in
adults older than 45 years old, the prevalence rose to
16.7%.2 Knee OA is characterized by joint pain and stiffness,
which frequently causes physical disability, and affects
quality of life and working ability.3
The main pathology of OA is destruction of the articular
cartilage and subchondral bone remodeling, followed by
narrowing of joint space and spur formation.4 Because the
center of gravity passes through the medial aspect of the
knee, there is more loading on the medial compartment of
the knee, thus causing more damage of articular cartilage
on the medial tibiofemoral joint. Subsequently, joint space
is more narrowed on the medial side, and varus deformity
of the knee develops.5 A varus mechanical axis increases
the distance from the center of the joint to the ground
reaction force vector, resulting in increase of external knee
adduction moment, which was reported by previous
studies.5,6
Treatment of OA includes patient education, weight
management, medications, therapeutic exercise, physical
modalities, orthosis, and surgery.7 In 2017, Cochrane sys-
temic review pooled data from 44 trials showed that ex-
ercise significantly reduced pain, and improved physical
function and quality of life in patients with knee OA. In
addition, more than 10 studies revealed that two-month to
six-month post-treatment sustained pain relief and
improved physical function after exercise training.8 The
American Academy of Orthopedic Surgeons (AAOS) and the
Osteoarthritis Research Society International (OARSI) also
recommended strengthening exercises for patients with
knee OA.9,10 Regarding physical agents for knee OA, the
results from pooled studies were inconclusive.11,12
An unloading or functioning knee brace is designed to
correct abnormal alignment and stress of the knee joint
based on biomechanical principles, and subsequently de-
creases joint pain and improves quality of life. It consti-
tutes one of the biomechanical approaches for knee
osteoarthritis. For patients with medial compartment knee
OA, a valgus knee brace is thought to reduce pain by
decreasing the load on the medial compartment through
the application of an external valgus force about the knee.
In addition, decrease of tibiofemoral angle, separation of
medial tibial and femoral condyles, and decreasing the
moment arm between the ground reaction force and knee
joint center were also reported.11,12
Over the past few years, there have been some studies
relating application of the unloading brace in the treatment
of knee OA.13e17 In a gait analysis, Kirkly et al. showed that
patients with medial compartment knee OA can benefit
significantly from the use of an unloading knee brace in
addition to standard medical treatment, and that the
unloading knee brace was more effective than a neoprene
sleeve.18 In a three-month follow-up study, Draper et al.
confirmed that wearing a valgus brace produced a signifi-
cant and immediate improvement in the function of pa-
tients with unicompartmental knee OA.19 Hurley et al.
found that brace use showed trends toward improvement in
WOMAC pain and WOMAC function, and that greater brace
use may positively affect physical activity.20
Although unloading knee braces have been utilized in
the Western countries for decades, they were introduced
into Taiwan only very recently. Consequently, there has
been little experience in the clinical application of
Western-made unloading knee braces in Taiwanese or other
Asian patients with knee OA. In addition, the effectiveness
of the unloading knee brace in patients with knee OA was
still debatable.9,21 The purpose of this study was to inves-
tigate the feasibility of wearing a Western-made unloading
knee brace in Taiwanese patients with medial compartment
knee OA, and also compare the effect of unloading knee
brace with that of physical therapy.
Methods
Participants
Patients with osteoarthritis of the knee were enrolled in
the study from the outpatient clinic of Physical Medicine
and Rehabilitation in one medical center. Recruitment took
place from October 2014 to November 2016. The inclusion
criteria were: age above 50yearsold, diagnosis of medial
compartment knee OA according to the criteria of the
American College of Rheumatology,4 severity of grade II to
grade IV by the Kellgren-Lawrence Grading Scale,22 exhib-
iting a willingness to try a Thruster Legacy OA brace (brace
group), or being able to receive three-month physiotherapy
program (PT group).
Criteria for exclusion were: history of knee joint oper-
ation, severe lateral tibio-femoral joint disease, severe
ligament instability, flexion contracture over 20 , being
unable to walk, skin allergy to metal (aluminum), or pe-
ripheral vascular disease or swelling of lower limbs that was

Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024
 + MODEL
Effect of Western-made unloading knee brace with physical therapy
not suitable for wearing a knee brace. Ethics approval was
received from the hospital’s ethics committee, and
informed consent was obtained from each patient prior to
participating in the study.
After enrollment, participants attempted to wear a
brace for one to two weeks, and modifications were made if
indicated, assisted by a technician from a brace company.
Only participants who could accept brace-wearing were
allocated into the brace group, and participants who did
not accept brace-wearing were excluded from the brace
group. The reasons for rejecting wearing a brace were
analyzed. The participants with medial compartment knee
OA showing willingness to participate in the physiotherapy
program for three months were assigned to the control
group.
Intervention
All of the participants received education in the care of
osteoarthritis of the knee and a home exercise program by
a physical therapist. Patients in the experimental group
wore a Thruster Legacy OA brace during walking in daily life
for at least three months. The duration of wearing a brace
was as long as the participants could tolerate. The total
time of brace-wearing was recorded by participants. Brace-
wearing was suggested to continue for at least three
months. The Thruster Legacy OA brace is a new generation
of knee brace made by the Bledsoe company. It is smaller
and lighter (only 1.2 kg) than the traditional type of knee
brace. In addition, up to 22 degrees of correction could be
applied. It is characterized by the design of a single-upright
model with an improved hinge that was only on the
affected side of the knee. It leads to relief of knee pressure
by pulling the straps to open the joint space rather than
pushing against the opposite side of the knee, as done by
traditional braces.
Participants in the control group received a physical
therapy program, including short-wave therapy (20 min),
middle frequency interferential current therapy (20 min),
and therapeutic exercise (20 min)three times per week for
three months. The therapeutic exercise included lower
limbs strengthening, stretch, and endurance training,
mainly focus on quadriceps strengthening exercise. The
training intensity was adjusted according to participants’
condition. A research assistant would remind the partici-
pants of both groups about the home exercise program and
knee brace-wearing (for the experimental group only). All
of the participants were prohibited from receiving any form
of corticosteroid injection or NSAIDs treatment, but acet-
aminophen was used as a rescue medication (participants
were asked to record the amount of medications that they
took every day).
Outcome measures
The primary outcome measures were the pain Visual
Analogue Scale (VAS) and the Western Ontario McMaster
University Osteoarthritis Index (WOMAC); the second
outcome measures were patients’ satisfaction and the
36-item Short-Form Health Survey (SF-36). All of the
Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024
3
evaluations were performed by a study assistant who was
blind to the group allocation. The patients were evalu-
ated at baseline, and at one month and three months
after the beginning of the treatment. At baseline, de-
mographic data, including age, gender, weight, height,
recreation, and sports activity were collected. Medical
history, regarding disease duration, use of medication,
corticosteroid injection, and concomitant diseases were
also recorded.
Pain visual analogue scale (pain VAS)
Pain VAS measures severity of pain. It was performed with a
100-mm horizontal line. The end of the left side was
defined as no pain, and the end of the right side as the
worst pain. Participants were requested to report the
severity of knee pain immediately after level walking for
10 m. The reliability of pain VAS is 0.94.23
Western Ontario McMaster University Osteoarthritis
Index (WOMAC)
The WOMACis a disease-specific, self-administered ques-
tionnaire for patients with OA of the knee or hip. It has
three separate subscales (with 24 individual scenarios),
measuring pain (5 scenarios), stiffness (2 scenarios), and
physical function (17 scenarios). It may be administered
using a Likert scale (0e4, where 0 is none and 4 is extreme)
or a 10-cm visual analog scale (VAS) (where 0 is none, and
10 is extreme).
These results are then scored on a 0e20 scale for pain,
0-8 scale for stiffness, and 0e68 scale for physical func-
tion. The WOMAC can also be recorded with a 10-cm VAS
(where 0 is none, and 10 is extreme). Higher scores for
both scales indicate a greater degree of pain, stiffness,
or physical dysfunction. Another version of the WOMAC
was represented on a metric scale (score of 0e100,
where 0 is no difficulty and 100 is the most difficulty).
WOMAC was a valid and reliable tool for determining the
status for OA of the knee or hip.24
Satisfaction with the treatment
Patient’s satisfaction with the treatment was recorded
using a 5-grade Likert scale: very satisfied, satisfied,
neutral, unsatisfied, and very unsatisfied.
36-Item Short Form health survey (SF-36)
The SF-36 is 36-item instrument that evaluates quality of
life. It comprises eight subscales, including physical func-
tioning, physical role, bodily pain, general health, vitality,
social functioning, emotional role, and mental health.
These eight scales can be summed up to two main domains
of physical health and psychological health. Each subscale
is scored from 0 to 100, with a higher score indicating a
better health condition. Currently, the SF-36 has been
validated for use in Taiwan.25
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4 L.-F. Hsieh et al.
Statistics
Means and standard deviations were reported for the
continuous measurements. Numbers were reported for the
categorical variables. The Fisher’s exact test was utilized
for group comparison of gender, side of involvement,
participation of exercise, use of medication, and history of
corticosteroid injection. The ManneWhitney U test was
used for group comparison of the quantitative data. For the
outcome measurement obtained from the satisfaction of
subjects, VAS pain (walking pain), WOMAC (including pain,
stiffness, and physical function), and the SF-36, the Gen-
eral Linear Model Repeated Measures, which has tests of
between-group effects (brace group and PT group)and tests
of within-group effects (evaluation time: pre-treatment,
one month, and three months post-treatment) were per-
formed. The Chi-square test, Fisher’s exact test, and
Kruskal-allis test were used for comparison between brace,
PT, and brace-withdrawal groups. The comparison of
acetaminophen consumption between brace and PT groups
was also performed using ManneWhitney U test. All statis-
tical significance levels were set at p value<.05, and the
Statistical Package for the Social Sciences (version 19.0;
SPSS Inc., Chicago, IL, U.S.A.) was used for all statistical
analyses. Total sample size of 36 patients (per group is 18)
was calculated for 90% power, a Z .05, b Z .9 and antic-
ipated effect size Z .25 using sample size free software
G*Power version 3.1.9.2, Germany.
Results
Participant recruitment and baseline
characteristics
We recruited 52 knee osteoarthritis participants who
exhibited a willingness to try the Thruster Legacy OA brace.
After a trial period of one-to two-weeks, 31 participants
withdrew due to pain or discomfort on wearing the brace
(11), other fitness problems (5), skin problems (3), poor
cosmesis (3), heaviness of brace (3), preparation for oper-
ation (2), and others (4). After exclusion of 31 participants
who withdrew from brace wearing, there were 21 partici-
pants in the brace group initially. During follow-up periods,
one participant in the brace group was lost to follow-up due
to long distance moving. We also recruited another 21
participants who had a regular physiotherapy program (PT
group) for osteoarthritis of the knee. In total, 20 patients
(seven males and 13 females, mean age: 67.7  6.6yr) were
in group 1 (brace group), and 21 patients (five males and 16
females, mean age: 65.7  7.6 yr) were in group 2 (PT
group). Compliance of brace was 39%, calculated by the
number of patients in the brace group divided by the total
number of patients who rejected and who accepted the
knee brace. Brace-wearing time was 2.1  1.9 h a day in
group 1. There were no significant differences regarding
demographic data and medical history except duration of
symptoms, which was significantly longer in group 1 (Table
1). For between-group comparison, no significant differ-
ences were observed with regard to walking pain VAS,WO-
MAC, SF-36, and patient’s satisfaction except stiffness in
WOMAC (P Z .006) and social functioning in SF-36
Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024
(P Z .007) (Tables 2 and 3). Time and group interaction
exhibited a significant interaction only in general health
(P Z .007) and mental health (P Z 0.006) of SF-36 (Table
3).
Within-group comparison found that walking pain VAS
and WOMAC decreased significantly at one months and
three months in both groups (Table 2, Fig. 1), indicating
improvement in both groups. Patient’s satisfaction was also
improved at three months in both groups (Table 2).
Comparison between brace group and brace-withdrawal
group showed significantly statistical difference regarding
the KL x-ray grading (P Z .014). There were more partici-
pants in the grade II, and grade IV in brace-withdrawal
group, compared with the other two groups (Table 4).
The acetaminophen consumption in the brace group was
1.8  4.4 tablets per month per person, and 1.9  3.9
tablets per month per person in the PT group. No signifi-
cantly statistical difference regarding acetaminophen
consumption between the two groups was observed
(P Z .592).
Discussion
This study demonstrated that the unloading knee brace was
as effective as physiotherapy in the treatment of medial
compartment knee OA. Although similar clinical studies
have been reported in Western populations, to the best of
our knowledge, it has rarely been reported in Asian pop-
ulations. This study confirmed that a Western-made
unloading knee brace may be applied in some Asian peo-
ple with medial compartment knee OA.
Although numerous non-surgical treatments exist for
knee osteoarthritis, many of them have not been proven
effective. The unloading knee brace has been demon-
strated to be effective in the treatment of knee osteoar-
thritis, and has been recommended by the Osteoarthritis
Research Society International (OARSI).10 Previous reports
suggested that varus malalignment of the knee is associated
with greater external adduction moment magnitudes during
walking, and increase of the adduction moment predicted
progression of medial knee OA.6 Unloading knee braces are
designed to correct varus malalignment and reduce
adduction moment of the knee, and thus decrease medial
knee loading and improve symptoms. In addition, Birming-
ham et al. also showed that unloading knee brace could
improve knee joint proprioception by increasing neuro-
muscular input. With better proprioception, patients could
have better control of standing and walking balance.26
Previous reports also showed that the unloading knee
brace could delay time for surgery, and possibly reduce
rates of OA progression.5,6 Traditionally, a knee brace is
supposed to decrease medial or lateral knee joint loading
via using a tree point principle. In this study, we used the
Thruster Legacy OA brace, which provides a four-point
unloading configuration for greater effect, and unloads
the affected joint space by pulling through the straps
rather than pushing against the opposite side of the knee.
The brace also possesses a hinge dial, which provides in-
cremental adjustments for fine tuning the amount of
unloading. It can provide up to 22 degrees of correction.
The brace is also lightweight and has a single-upright,
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Effect of Western-made unloading knee brace with physical therapy 5

Table 1 Demographic and clinical characteristics of the subjects on the baseline.

Characteristics Brace group (n Z 20) PT group (n Z 21) P value
Gender (n)
Male 7 5 0.505a
Female 13 16
Agec (yr) 67.7  6.6 65.7  7.6 0.530b
Weightc (kg) 67.8  8.7 66.6  12.3 0.465b
Heightc (cm) 161.6  7.1 157.9  5.6 0.099b
Disease durationc (mon) 11.7  9.5 6.4  7.1 0.035b
Side of involvement(n)
Right 10 12 0.758a
Left 10 9
Exercise (n)
Yes 4 6 0.719a
No 16 15
Recreation (n)
Yes 4 6 0.719a
No 16 15
Medication (n)
Yes 11 9 0.538a
No 9 12
History of corticosteroid injections(n)
Yes 7 3 0.159a
No 13 18
KL X-ray grading 0.065a
II 5 11
III 13 10
IV 2 0
Abbreviation: PT, physical therapy; SEM, standard error of the mean; KL, Kellegren Lawrence.
a
Chi-square test: Fisher’s exact test.
b
Mann-Whitney U test.
c
Values are mean  SD.

Table 2 Effects of times and groups on pain, WOMAC, and satisfaction.a,b

Measures Group Evaluation time Time effects Group effects Time and group
interactions
Pretreatment Post one months Post three months P P P
Satisfaction Brace e 2.5  0.5 2.1  0.5 <0.001 0.625 0.706
PT e 2.6  0.8 2.1  0.6
VAS (Walking pain) Brace 4.4  2.4 3.1  1.6 2.1  1.3 <0.001 0.254 0.478
PT 4.1  2.2 2  2.2 1.8  2.1
WOMAC Brace 759.5  393.9 557.3  346.5 355.7  271.4 <0.001 0.092 0.478
PT 590.6  292.7 395.6  268.3 294.8  219.9
Pain Brace 150.3  92.9 86.5  59.4 63.6  53.6 <0.001 0.344 0.173
PT 113.1  67.8 87.9  74.1 65.8  46.6
Stiffness Brace 35.7  27 29.8  24 21.7  23.5 0.004 0.006 0.141
PT 17.9  26.2 8.4  14.8 10.8  21
Physical function Brace 513.9  286.9 398.9  257.4 242.5  196.8 0.001 0.078 0.593
PT 427  211.6 271.7  171.4 200.7  157.2
Abbreviation: VAS, Visual Analog Scale; WOMAC, Western Ontario McMaster University Osteoarthritis Index.
a
General linear model repeated measure.
b
Values are mean  SD.

Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024
 + MODEL
6 L.-F. Hsieh et al.

Table 3 Effects of times and groups on the SF-36.a,b

Measures Group Evaluation time Time effects Group effects Time and group interactions
Pretreatment Post one months Post three months P P P
PF Brace 50.5  22.5 60  21.5 67.5 18.2 <0.001 0.093 0.495
PT 60.7  10.2 67.9  9.9 71.7  14
RP Brace 40  39.2 53.8  41.6 58.8  47.5 0.002 0.616 0.838
PT 41.7  49.6 61.9  41.5 66.7  43.5
BP Brace 55.6  19.2 62.9  8.8 68.4  18 <0.001 0.745 0.606
PT 54  14.8 65  16.4 71.8  16.1
GH Brace 62.1  17.1 62.2  14.4 67.8  14.5 0.851 0.643 0.007
PT 64.6  20.6 62.2  22.2 58  18.9
VT Brace 61.5  17.3 65  13.2 63  13.1 0.541 0.817 0.920
PT 63.6  15 65.2  16.8 63.6  18.7
SF Brace 72  21 75.8  18.5 81.5  17 0.371 0.017 0.183
PT 89.3  19.5 86.3  17.3 87.5  16.4
RE Brace 65 43.9 66.6  40.5 71.7  39.5 0.602 0.921 0.809
PT 68.2  46.5 61.9  46.3 69.9  43.4
MH Brace 70.4  16.4 74  16.3 75.4  12.9 0.732 0.699 0.006
PT 78.5 15.8 75.4  17.8 71.2  17.3
Abbreviation: SF-36, Short Form-36 Item Health Survey; PF, physical functioning; RP, role limitation due to physical problems; BP, bodily
pain; GH, general health; VT, vitality; SF, social functioning; RE, role limitation due to emotional problems; MH, mental health.
a
General linear model repeated measure.
b
Values are mean  SD.

which is designed to be placed on the affected side of the
knee. Currently, to the best of our knowledge, there is no
clinical trial for comparing the efficacy or biomechanics
between a three-point load system and a four-point load
system.
In a prospective study of the effects of orthotic treat-
ment of medial knee OA in Chinese patients, Fu et al.
demonstrated that a valgus knee brace significantly
reduced VAS pain score and WOMAC pain score, but
compliance was only 54.5%, which is lower than that for any
of the insole groups.27 Fu suggested that the low compli-
ance might be due to the bulky size of the knee brace,
causing skin discomfort. In our study, 31 participants
withdrew initially due to brace fitting or other problems,
one participant lost to follow up, thus only 20 of 52 par-
ticipants were willing to complete the whole brace wearing
course. Though knee brace do have the same effect as
physical therapy, the social acceptance limits its
popularity.
In another study conducted by Ostrander et al., medial
knee OA patients who wore an unloading knee brace had
less pain and better ability to engage in activities of daily
living.28 Ostrander also mentioned the discomfort of the
brace, which made some patients drop out from the study.
He also suggested that obese patients or patients with skin
or vascular issues may not be candidates for braces. In a
survey of the use of unloading knee brace, only 28% from 89
responders reported regular brace use, and the reason for

Figure 1 Time and group interaction of VAS and WOMAC.

Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024
 + MODEL
Effect of Western-made unloading knee brace with physical therapy 7

Table 4 Clinical characteristics of between withdraw group and study groups.

Characteristics Withdraw Group (n Z 31) Brace group (n Z 20) PT group (n Z 21) P value
Gender,n (%)
Male 9 (29) 7 (35) 5 (24) 0.716a
Female 22 (71) 13 (65) 16 (76)
Age (yr), mean  SD 69.6  8.0 67.7  6.6 65.7  7.7 0.232b
Weight (kg) 70.0  19.5 67.8  8.7 66.6  12.3 0.744b
Height (cm) 154.2  21.5 161.6  7.1 157.9  5.6 0.160b
X-ray grading 0.014a
II 12 (39) 5 (25) 11 (52)
III 10 (32) 13 (65) 10 (48)
IV 9 (29) 2 (10) 0
a
Chi-square test: Fisher’s exact test.
b
Kruskal-Wallis Test.

discontinuing the brace were lack of symptomatic relief,
brace discomfort, poor fit, and skin irritations.29 In our
study, the unloading knee brace is made in the U.S., and we
suspected that a Western-made brace may not fit the OA
knee of most Asian patients. In our study, there were 31
participants who refused to wear a knee brace. Among
them, poor fitness was the most common reason (16/31),
followed by poor cosmesis, and heaviness of the brace. In
general, patients with a body height less than 150 cm found
it difficult to wear the brace, because their legs are not
long enough for the length of the brace. Prescription of
knee braces should consider not only biomechanical ef-
fects, but also the fitness of a particular brace. In clinical
practice, patients are encouraged to try on the brace for a
few days before purchasing.
The brace-withdrawal group showed significantly more
participants in the KL grade II and grade IV, compared with
the brace group. In addition, participants in the brace-
withdrawal group tended to have a shorter stature,
although statistical difference was not reached. The results
may hint that participants in KL grade III were more
acceptable to brace wearing, because they felt less pain on
walking with brace and the discomfort of brace wearing
could be ignored. On the contrary, participants in grade II
had less pain on walking, and they felt that the benefit of
brace wearing was not high enough for them to neglect the
discomfort on brace wearing. In participants with grade IV
OA, their joint conditions were too bad, so the brace was
not effective. The shorter stature in this group also inter-
fere knee brace fitting.
Treatment of knee OA in the PT group included physical
modalities (heat therapy, electric therapy, etc.) and ther-
apeutic exercise (strengthening exercises, stretch and
range-of-motion exercises, functional training, etc.).
Although the effect of physical agents for the treatment of
knee OA is still inconclusive, most studies reported a posi-
tive effect of strengthening exercises for knee OA, and the
effect could persist two-to six-months after treatment.8e10
A Cochrane review of 54 trials concluded that there is
moderate-to high-quality evidence suggesting that land-
based exercise improves knee pain, function and quality
of life with moderate effect size immediately after treat-
ment.8 Another systemic review article also showed muscle
group strengthening exercise such as quadriceps,
hamstrings, and hip abductors could improve joint stabili-
zation, walking endurance and balance because the muscle
group of knee OA patients were usually weak due to pain
inhibition and decondition.30 Our study also found a posi-
tive effect of physiotherapy, although there was no control
group in our study.
There are some limitations in this study. First, although
randomization and a blind method are difficult to perform
in this clinical study, we used a PT group for comparison.
Second, there was no non-treatment group, and thus we do
not know whether the improvement in each group was due
to spontaneous recovery. Third, due to budget limitations,
since the case number is small, a type II error is possible.
Fourth, since we follow-up for only three months, we do
not know the long-term result. Further long-term follow up,
perhaps 6 months or 1 year, is warranted.
Conclusion
This study demonstrated that a Western-made unloading
knee brace could relieve pain, and improve function and
quality of life in some Asian patients with knee OA in the
short term, and was as effective as regular physiotherapy. A
trial of brace-wearing is suggested prior to application of
the unloading knee brace in patients with knee OA.
Conflicts of interest
The authors have no conflicts of interest relevant to this
article.
Supplier
Thruster Legacy OA brace; Breg, Inc.
Acknowledgement
We are grateful for financial support from Shin Kong Wu Ho-
Su Memorial Hospital. We are also thankful for statistical
assistance from Ms. Chyi-Huey Bai and technical assistance
from Teh Lin Prosthetic and Orthopaedic, Inc.

Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024
 + MODEL
8 L.-F. Hsieh et al.

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Please cite this article as: Hsieh L-F et al., Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian
patients with medial compartment knee osteoarthritisdA preliminary report, Journal of the Formosan Medical Association, https://
doi.org/10.1016/j.jfma.2019.05.024