International Journal of Rheumatic Diseases 2012; 15: 197–206

ORIGINAL ARTICLE

Therapeutic ultrasound versus sham ultrasound for the

management of patients with knee osteoarthritis:
a randomized double-blind controlled clinical study
Yasemin ULUS, Berna TANDER, Yesim AKYOL, Dilek DURMUS, Ozlem BUYUKAKINCAK,
Ulku GUL, Ferhan CANTURK, Ayhan BILGICI and Omer KURU
Department of Physical Medicine and Rehabilitation, Medical Faculty, Ondokuz Mayis University, Samsun, Turkey

Abstract
Aim: The aim of this trial was to evaluate the short-term effectiveness of ultrasound (US) therapy on pain, phys-
ical function, ambulation activity, disability and psychological status in patients with knee OA.
Methods: Forty-two inpatients with bilateral knee OA were randomized by an independent researcher not
involved in the data assessment, to receive either therapeutic continuous US (group 1) or sham US (group 2). A
1-MHz US head was used, set to an intensity of 1 W/cm2 for 10 min. All patients received 20 min of hot packs,
10 min of interferential current, and 15 min of quadriceps isometric exercise of both knees. Patients in each
group received treatments five times weekly for 3 weeks. Patients were evaluated at baseline and at the end of
the treatment sessions. Outcome measures included visual analogue scale (VAS), Western Ontario and McMaster
University Osteoarthritis Index (WOMAC), 50-m walking speed, Lequesne index, Hospital Anxiety and Depres-
sion Scale (HADS).
Results: The patients with knee OA had significant improvements in pain, stiffness, functional activity, walking
time, disability, depression and anxiety scores with therapeutic US and sham US (P < 0.05). The improvement
in pain VAS scores, WOMAC scores, Lequesne index and HADS scores were not significantly different in patients
treated with US and sham US (P > 0.05). No side-effects were reported during or after the US treatment periods.
Conclusion: US therapy is safe but use of US in addition to conventional physical therapy programs seems to
have no further significant effect in people with knee OA.
Key words: depression, disability, knee osteoarthritis, pain, therapeutic ultrasound.

global cause of disability in women and the eighth

INTRODUCTION
Osteoarthritis (OA) is the most common rheumatologic
disease in humans. The individual joints most com-
monly affected by OA are the knee, hip, hand, spine
and foot.1 Knee OA is the most common form of symp-
tomatic OA. The report by the World Health Organiza-
tion on the global burden of disease indicates that knee
OA is likely to become the fourth most important
Correspondence: Yasemin Ulus, Department of Physical
Medicine and Rehabilitation, Medical Faculty, Ondokuz Mayis
University, Samsun, Turkey. Email: yaseminulus@gmail.com
most important cause in men.2
The objectives of management of knee OA are to
relieve pain and to maintain or improve function. Clin-
ical guidelines for managing knee OA which have been
published by the American College of Rheumatology
(ACR) and the European League Against Rheumatism
(EULAR), recommend a combination of nonpharmaco-
logic (i.e. education, exercise, lifestyle changes and
physical therapy) and pharmacologic (i.e. paracetamol,
nonsteroidal antiinflammatory drugs, and topical
agents) treatments.3,4 Physical agents like short-wave
diathermy, transcutaneous electrical nerve stimulation,

© 2012 The Authors

International Journal of Rheumatic Diseases
© 2012 Asia Pacific League of Associations for Rheumatology and Blackwell Publishing Asia Pty Ltd
Y. Ulus et al.
ultrasound (US) and hot packs are noninvasive modali-
ties that are commonly used to control both acute and
chronic pain arising from several conditions.5
Therapeutic US is a well-established deep-heating
modality that converts mechanical energy into a form
of sound waves. US is used to treat many musculoskele-
tal diseases and is also reputed to reduce edema, relieve
pain, increase range of motion and accelerate tissue
repair.6 It is one of several physical therapy modalities
suggested for the management of pain and loss of func-
tion due to OA and can be used as part of an overall
rehabilitation program.7 US may be administered in
either a continuous or a pulsed mode.8 Pulsed US
produces non-thermal effects and is used to aid in
the reduction of inflammation, whereas continuous
US generates thermal effects.9,10 Both modes are often
used in the management of painful musculoskeletal
disorders.
Decreased physical activity due to prolonged persis-
tent pain leads to anxiety and depression. Such psycho-
logical changes and pain contribute to disability, which
has a negative effect on perceived quality of life
(QoL).11 Primary goals of rehabilitation of musculo-
skeletal problems are to decrease symptoms, to opti-
mize daily function and to minimize disability.12
There are several studies which compare the effects of
US and the other physical therapy modalities or pla-
cebo on patients with knee OA.5,13–18 According to
these studies the clinical efficacy of US is controversial.
Despite these results, US is very popular in the treat-
ment of musculoskeletal disorders.
The aim of this prospective randomized double-blind
placebo-controlled trial was to evaluate the short-term
effectiveness of continuous US therapy on pain, physi-
cal function, ambulation activity, disability, and
psychological status in patients with knee OA.
MATERIALS AND METHODS
A prospective randomized placebo-controlled clinical
trial was conducted at the Department of Physical Med-
icine and Rehabilitation, Medical Faculty of Ondokuz
Mayis University, Samsun, Turkey. Forty-two inpatients
with bilateral knee OA diagnosed in accordance with
the American College of Rheumatology criteria were
included in the study.19 Patients were excluded from
the study if they had any contraindication for physical
therapy, previous history of knee surgery, lower extrem-
ity arthroplasty, local dermatological problems, any sys-
temic illness or abnormal laboratory test results, had
been on any physiotherapy program or received intra-
198
articular injection of hyaluronic acid or steroids or US
therapy in the last 6 months, or had symptoms and
signs of acute synovitis.
In order to have statistical power of 0.98, and
P < 0.05, the minimum number of subjects per group
was estimated to be 20 subjects to detect the differences
in total Western Ontario and McMaster University
Osteoarthritis Index (WOMAC) scores before and after
treatment.
All patients were initially questioned about age, sex,
working status, educational level and duration of knee
OA; weight and height of patients were also measured.
Patients were evaluated at baseline and at the end of the
treatment sessions by the physician, who was blinded
with regard to the type of treatment the patients would
receive.
The local ethics committee approved the study proto-
col and all patients gave written informed consent.
Measurement of pain severity
Patients were asked to state the level of pain on a 10-cm
visual analogue scale (VAS) at rest and in activity: the
score 0 indicated no pain and 10 indicated very severe
pain.20
Functional ability
The Turkish version of the WOMAC was used to assess
the functional ability of the patients.21 WOMAC scoring
is a three-dimensional, disease-specific, self-adminis-
tered health status measure.22 It has been found to be a
valid and reliable tool to use in patients with knee
OA.23,24 The 24-item WOMAC instrument is a health
status instrument that assesses a participant’s perception
of pain (5 questions, score range: 0–20), joint stiffness
(2 questions, score range: 0–8), and physical function
(17 questions, score range: 0–68). Higher scores indi-
cate more or worse symptoms, limitations and poor
health.
Measurement of ambulation activity
Ambulation activity was evaluated by the patient’s walk-
ing speed. The time required to walk a distance of 50 m
as fast as possible was measured with a stopwatch and
recorded in seconds.
Measurement of disability
Each patient’s disability was evaluated with the
Lequesne index.25 The questionnaire included 11 ques-
tions about knee discomfort, endurance of ambulation,
and difficulties in daily life. A maximum score of 26
indicates the greatest degree of dysfunction.
International Journal of Rheumatic Diseases 2012; 15: 197–206

Psychological status
Psychological status was assessed by the Hospital Anxiety
and Depression Scale (HADS). HADS is a self-assessment
questionnaire containing 14 questions developed to
detect states of anxiety and depression and is specifically
designed for nonpsychiatric hospital departments.26 In
this questionnaire, there are four possible response
options to each question, which are scored from 0 to 3
points depending on the severity of the symptoms. There
are seven questions related to depressive symptoms
(HADS-D subscale) and seven concerning anxiety symp-
toms (HADS-A subscale). The validity of the Turkish
form of HADS was performed by Aydemir et al.27
Therapy
Following baseline assessment, an independent
researcher not involved in the data assessment, ran-
domized the participants, according to computer-gener-
ated random numbers sealed in opaque envelopes with
consecutive numbering, to receive either therapeutic US
(group 1) or placebo (group 2, sham US). A Sonopuls
434 US machine (Enraf Nonius, Rotterdam, The Neth-
erlands) was used for US therapy. Continuous ultra-
sonic waves of 1 MHz frequency and intensity of
1 W/cm2 were applied with a 5-cm diameter applicator
for 10 min per session. The patient was kept in a supine
position with both knees fully extended while US was
applied around the knee joint with full contact for
10 min. Aqueous gel was used as a coupling medium
in circular movements with the probe at right angles
during US application.
In group 2, the US device was set to the “on” mode,
dials were lit but no energy was delivered to the tissue,
and an applicator was also disconnected from the back
of the US machine. The transducer head was applied to
the same area in the same manner described above and
the same aquasonic transmission gel was used.
All patients received 20 min of hot packs, 10 min of
interferential current, and 15 min of quadriceps isomet-
ric exercise of both knees. Patients in each group
received treatments five times weekly for 3 weeks. Non-
steroidal anti-inflammatory drugs and antidepressant
drugs were not permitted throughout the physical ther-
apy sessions; analgesics whenever needed and other
medications for comorbid diseases were permitted
during study period.
Statistical analyses
The data were analyzed using the Statistical Package for
Social Sciences (SPSS) version 16 software for Windows
International Journal of Rheumatic Diseases 2012; 15: 197–206
Therapeutic ultrasound in knee osteoarthritis
(SPSS Inc., Chicago, IL, USA). Data were presented as
mean ± standard deviation (SD), median (minimum;
maximum; interquartile range [IQR]). The Kolmogorov
Simirnov test was used to analyze normal distribution
assumption of the quantitative outcomes and all data
were normally distributed. Paired t-sample t-test was
used to compare pre- and post-treatment changes in
each group. Student’s t-test was used to compare the
groups. The sociodemographical characteristics of the
groups were evaluated by Chi-square test. For the com-
parison of before and after treatment changes between
the groups, the independent samples t-test was used.
P-values < 0.05 were considered statistically significant.
RESULTS
Forty-two patients were included in the study. Twenty
subjects in group 1 and 20 subjects in group 2 com-
pleted the 15-day intervention program. One subject
each from groups 1 and 2 withdrew from the study
because they could not spare time for the physical ther-
apy sessions. Figure 1 presents the overall plan of the
study.
The mean age of group 1 and group 2 were
60.70 ± 10.14 and 60.25 ± 8.8 years, respectively. The
majority of patients in all groups were female.
Table 1 provides the clinical and demographic data
of the patients. There were no statistically significant
differences in sociodemographic and clinical data
between the groups (P > 0.05).
There were no significant changes in clinical parame-
ters between the groups (P > 0.05; Table 2).
Pain
Pain VAS scores at rest and on activity decreased signifi-
cantly in both groups (P < 0.05; Table 3), but there
was no statistically significant difference between the
groups after the treatment (P > 0.05; Table 4).
Functional ability
There were also significant improvements for WOMAC
pain, physical function, stiffness and total scores in
both groups (P < 0.05; Table 3). After the treatment,
statistically significant differences could not be demon-
strated between the groups (P > 0.05; Table 4).
Ambulation speed
There were statistically significant improvements in
50 m walking time in both groups (P < 0.05; Table 3).
There was no statistically significant difference between
the groups after the treatment (P > 0.05; Table 4).
199
Y. Ulus et al.
Patients with bilateral knee osteoarthritis
Initial assessment Group I
(before treatment)
n = 20
Therapeutic US
3 weeks therapy Hot packs, interferential current,
exercise
Second assessment
(after treatment)
n = 20
Figure 1 Flowchart diagram for participants who were randomized into two groups receiving either ultrasound (US) or sham US.
Analysis was completed on a total of 40 patients.
Disability
The average Lequesne index scores decreased signifi-
cantly in both groups after treatment (P < 0.05;
Table 3). Statistically significant differences could not
be demonstrated between the groups after the treatment
(P > 0.05; Table 4).
Psychological status
The anxiety and depression subscores were reduced in
both groups after treatment (P < 0.05; Table 3), but
subscores were statistically similar between the groups
after the treatment (P > 0.05; Table 4).
DISCUSSION
Osteoarthritis is a common disease associated with sig-
nificant morbidity. It is an age-related condition, occur-
ring more frequently in women than in men.28 The
most common symptom is pain on movement, result-
ing in restriction of an individual’s activities of daily
living and consequently having a significant impact on
QoL.29 In the literature, there are conflicting results on
the efficacy of US treatment in knee OA. In this study
the effectiveness of therapeutic continuous US and
sham US in knee OA were compared and after physical
therapy sessions, each group showed significant
improvement in the main outcome variables: pain
intensity, WOMAC scores, depression and anxiety
subscores but there were no differences between the
outcomes of the two groups.
The 2010 Osteoarthritis Research Society Interna-
tional recommendations for the management of hip
200
n = 42
Two dropouts
Group II
n = 20
Placebo (sham US)
Hot packs, interferential current
exercise
n = 20
and knee OA state that the optimal management of OA
requires a combination of non-pharmacological and
pharmacological modalities, including physical ther-
apy, but does not specifically mention US as a treat-
ment adjunct.30 Several authors have researched the
effectiveness of therapeutic US and there are controver-
sial results about the clinical efficacy of US.5,13–18 The
efficacy of US on knee OA is still inconclusive so in this
trial the investigation of effects of US on knee OA was
sought.
In a review by Welch et al.31 only one trial compared
therapeutic US to placebo and they concluded that US
therapy appears to have no benefit over placebo or
short-wave diathermy for patients with knee OA. This
review was updated by Rutjes et al.9 and their results
suggested that therapeutic US may be beneficial for
patients with OA of the knee. According to these
reviews; because the poor reporting of the characteris-
tics of the device, the population, the stage of OA,
therapeutic application of the US and overall low
methodological quality of the trials included, these con-
clusions are limited.
There are three trials which have acceptable methodo-
logical quality according to the review by Rutjes et al.,
using a sham intervention in the control group.14,16,18
In a study by Huang et al., US was not applied to con-
trol patients so it could not be accepted as a sham US.
In the current study one group received US and other
group received sham US.
The trial by Falconer et al. was conducted to
determine the effectiveness of US in relieving stiffness
and pain in patients who had knee OA and chronic
knee contracture. They concluded that US may not
International Journal of Rheumatic Diseases 2012; 15: 197–206
 Therapeutic ultrasound in knee osteoarthritis

Table 1 Sociodemographic characteristics and baseline clinical measurements of the patients

Characteristics Group 1 (n = 20, F/M = 17/3) Group 2 (n = 20, F/M = 17/3) P

Mean ± SD Mean ± SD
Median (min max) Median (min max)
Age (years) 60.70 ± 10.14 60.25 ± 8.8 0.882
61.5 (42–73) 60 (42–75)
Height (cm) 159.80 ± 6.48 158.65 ± 7.78 0.615
154 (150–176) 160 (150–171)
Weight (kg) 80.65 ± 11.56 77.95 ± 10.71 0.449
80 (62–105) 80 (60–100)
Body mass index (kg/m²) 31.60 ± 4.42 31.07 ± 4.71 0.712
32 (24–42) 30 (25–44)
Duration of symptoms (months) 92.25 ± 93.71 120.55 ± 113.63 0.396
48 (2–240) 108 (2–480)
50 m walking time (s) 77.95 ± 48.41 57.20 ± 18.18 0.810
70 (40–240) 49 (37–90)
Pain VAS (rest) 4.80 ± 1.82 4.80 ± 2.39 1.000
5 (0–8) 4.5 (0–9)
Pain VAS (activity) 6.10 ± 1.58 7.20 ± 2.01 0.063
6 (2–8) 8 (3–10)
WOMAC score
Pain subscale 15.70 ± 3.35 14.65 ± 3.06 0.308
14 (10–21) 15 (8–19)
Stiffness subscale 5.70 ± 1.59 5.50 ± 2.62 0.772
6 (2–8) 5 (2–13)
Function subscale 47.30 ± 10.91 47.60 ± 10.97 0.931
49 (24–61) 48 (27–66)
Total 68.65 ± 13.85 67.75 ± 14.07 0.840
69 (44–87) 69 (41–90)
Lequesne index 13.70 ± 3.61 12.70 ± 3.19 0.360
15 (2–19) 13 (5–17)
HAD anxiety subscore 8.50 ± 3.84 9.05 ± 5.15 0.704
8 (0–14) 8 (2–19)
HAD depression subscore 7.20 ± 4.87 7.60 ± 5.95 0.817
7 (0–16) 7 (1–20)
n n
Occupation
Housewife 14 11 0.252
Retired 5 5
Other 1 4
Education
Literate 1 2 0.714
Primary education 7 10
Secondary education 3 1
College 4 3
Severity on radiograph
Grade 2 9 8 0.749
Grade 3 11 12
P-value is significant at <0.05. HAD, Hospital Anxiety and Depression scale; SD, standard deviation; VAS, visual analogue scale; WOMAC, Western
Ontario McMaster osteoarthritis index.

contribute to the management of patients with chronic excluded. In Falconer’s study US application time was
knee stiffness and OA.18 For this reason in the current 3 min and intensity of the US was not constant,
study patients who had chronic knee contracture were whereas in the current study US constant frequency

International Journal of Rheumatic Diseases 2012; 15: 197–206 201

Y. Ulus et al.

Table 2 The comparison of before and after treatment changes between the groups
Characteristics Group 1 (n = 20) Group 2 (n = 20) P 95% CI of the difference

Mean change Lower Upper

Mean ± SD
50 m walking time (s) 9.9 ± 6.63 6.15 ± 6.04 0.074 7.86 0.38
Pain VAS (rest) 2.5 ± 1.31 1.85 ± 1.75 0.193 1.64 0.34
Pain VAS (activity) 2.8 ± 1.57 2.75 ± 1.71 0.924 1.10 1.00
WOMAC
Pain subscale 6.50 ± 3.25 4.57 ± 3.16 0.070 4.00 0.16
Stiffness subscale 2.30 ± 1.26 1.45 ± 1.27 0.056 1.66 0.037
Function subscale 18.85 ± 9.21 15.05 ± 15.49 0.256 10.46 2.86
Total 26.90 ± 11.57 21.10 ± 13.91 0.160 13.99 2.39
Lequesne index 4.05 ± 3.89 3.35 ± 3.39 0.548 3.03 1.63
HAD anxiety subscore 2.10 ± 2.77 1.65 ± 1.92 0.554 1.97 1.07
HAD depression subscore 1.65 ± 2.77 1.35 ± 2.15 0.705 1.89 1.29
P-value is significant at <0.05. HAD, Hospital Anxiety and Depression scale; SD, standard deviation; VAS, visual analogue scale; WOMAC, Western
Ontario McMaster osteoarthritis index.

(1 MHz) and intensity (1 W/cm2) was applied for
10 min. In degenerative arthritis US therapy with con-
stant intensity (0.5–2 W/cm2) for 5–10 min was recom-
mended.32
In a study by Özgönenel et al.,14 US or sham US as a
placebo were applied to patients with knee OA and they
concluded that US has been superior over placebo in
the treatment of OA of the knee. In this study it was
unclear if concurrent treatment was given, with the
authors stating that ‘no physiotherapy was prescribed
prior to US treatment to either of the groups’, but refer-
ring to their intervention as a physiotherapy program.
Therefore, it could not be excluded that other physio-
therapy modalities were provided in addition to US
treatment.
In a recent study, Taşçıoğlu et al.13 compared the
effect of continuous, pulsed and sham US on knee OA
and they concluded that pulsed US therapy was a safe
and effective treatment modality in patients with knee
OA. Özgönenel and Taşçıoğlu compared only VAS pain
scores and WOMAC scores in their studies; there were
no disability and psychological status assessments. Pain
and depression frequently coexist and have an additive
effect on adverse health outcomes and treatment
responsiveness,33 so in the current study, disability and
depression–anxiety scores were evaluated.
Pain, which is a very important symptom in OA, may
be caused by several conditions which result in changes
of intra-articular and periarticular connective tissues.
Pain relief and improvement of function in knee
OA with US therapy were reported in other stud-
ies.13,14,16,17 In this study VAS pain scores improved in
both patients receiving US or sham US.
Patients with OA often present with pain and limi-
tations of physical function.34 Walking time is an
important indicator of functional performance and
there are several tests that measure walking ability
either by measuring time required to walk a defined
distance or how far an individual can walk in a
defined time. As a performance-based measure of
function, a 50 m walking time was used in this study,
and improvement in 50 m walking time was obtained
in both groups.
Previous studies suggested the use of WOMAC in
the assessment of clinical improvements in patients
with hip and knee OA.23,24 In the literature there
were studies which reported improvements of WO-
MAC scores in knee OA with US and other physical
therapy modalities,15,17 but in two trials it was
reported that these improvements were significant in
the US group.13,14 In the current study the improve-
ment in functional status according to WOMAC
scores was not significantly different in patients after
either US or sham US treatment.
Impairment and disability are important components
of the patient’s perception of the disease35 and disabil-
ity is frequently reported in patients with knee OA.16
Lequesne index was validated and it is used for long-
term follow-up of OA of the knee.36 In this study,
Lequesne disability scores decreased significantly in
both groups after the treatment. In the literature there is
no evaluation of disability with sham US, therefore in

202 International Journal of Rheumatic Diseases 2012; 15: 197–206

 Therapeutic ultrasound in knee osteoarthritis

Table 3 Pre- and post-treatment clinical measurement values of the patient groups
Characteristics Group 1 (n = 20) P Group 2 (n = 20) P

Mean ± SD Mean ± SD
Median (min max) Median (min max)
50 m walking time (s)
BT 77.95 ± 48.41 0.001 57.20 ± 18.18 0.001
70 (40–240) 48 (37–90)
AT 68.05 ± 44.53 51.25 ± 15.74
58 (35–225) 46 (30–80)
Pain VAS (rest)
BT 4.80 ± 1.82 0.001 4.80 ± 2.39 0.001
5 (0–8) 4 (0–9)
AT 2.30 ± 1.68 2.95 ± 2.32
2 (0–5) 3 (0–7)
Pain VAS (activity)
BT 6.10 ± 1.58 0.001 7.20 ± 2.01 0.001
6 (2–8) 8 (3–10)
AT 3.30 ± 1.83 4.45 ± 2.16
3 (1–7) 5 (0–8)
WOMAC
Pain subscale
BT 15.70 ± 3.35 0.001 14.65 ± 3.06 0.001
14 (10–21) 15 (8–19)
AT 9.20 ± 3.59 10.15 ± 2.92
8 (3–16) 10 (5–15)
Stiffness subscale
BT 5.70 ± 1.59 0.001 5.50 ± 2.62 0.001
6 (2–8) 5 (2–13)
AT 3.40 ± 1.46 4.05 ± 1.84
3 (0–6) 4 (2–9)
Function subscale
BT 47.30 ± 10.91 0.001 47.60 ± 10.97 0.001
49 (24–61) 47 (27–66)
AT 28.65 ± 10.62 32.45 ± 7.33
26 (5–57) 33 (17–43)
Total
BT 68.65 ± 13.85 0.001 67.75 ± 14.07 0.001
68 (44–87) 69 (41–90)
AT 41.75 ± 14.22 46.65 ± 10.54
39 (8–75) 47 (24–63)
Lequesne index
BT 13.70 ± 3.61 0.001 12.70 ± 3.19 0.001
14 (2–19) 13 (5–17)
AT 9.65 ± 4.51 9.35 ± 3.39
10 (2–17) 10 (3–15)
HAD anxiety subscore
BT 8.50 ± 3.84 0.003 9.05 ± 5.15 0.001
8 (0–14) 7 (2–19)
AT 6.40 ± 3.57 7.40 ± 5.39
6 (0–12) 6 (1–19)

(continued)

International Journal of Rheumatic Diseases 2012; 15: 197–206 203

Y. Ulus et al.

Table 3 (continued)
Characteristics Group 1 (n = 20) P Group 2 (n = 20) P

Mean ± SD Mean ± SD
Median (min max) Median (min max)
HAD depression subscore
BT 7.20 ± 4.87 0.016 7.60 ± 5.95 0.012
7 (0–16) 6 (1–20)
AT 5.55 ± 3.94 6.25 ± 4.71
4 (0–15) 5 (0–16)
P-value is significant at <0.05. AT, after treatment; BT, before treatment; HAD, Hospital Anxiety and Depression scale; SD, standard deviation; VAS,
visual analogue scale; WOMAC, Western Ontario McMaster osteoarthritis index.

Table 4 The comparison of post-treatment clinical measurements between the groups

Characteristics Group 1 (n = 20) Group 2 (n = 20) P

Mean ± SD Mean ± SD
Median (min max) Median (min max)
50 m walking time (s) 68.05 ± 44.53 51.25 ± 15.74 0.120
58 (35–225) 46 (30–80)
Pain VAS (rest) 2.30 ± 1.68 2.95 ± 2.32 0.319
2 (0–5) 3 (0–7)
Pain VAS (activity) 3.30 ± 1.83 4.45 ± 2.16 0.078
3 (1–7) 5 (0–8)
WOMAC
Pain subscale 9.20 ± 3.59 10.15 ± 2.92 0.365
8 (3–16) 10 (5–15)
Stiffness subscale 3.40 ± 1.46 4.05 ± 1.84 0.225
3 (0–6) 4 (2–9)
Function subscale 28.65 ± 10.62 32.45 ± 7.33 0.196
26 (5–57) 33 (17–43)
Total 41.75 ± 14.22 46.65 ± 10.54 0.223
39 (8–75) 47 (24–63)
Lequesne index 9.65 ± 4.51 9.35 ± 3.39 0.813
10 (2–17) 10 (3–15)
HAD anxiety subscore 6.40 ± 3.57 7.40 ± 5.39 0.494
6 (0–12) 6 (1–19)
HAD depression subscore 5.55 ± 3.94 6.25 ± 4.71 0.613
4 (0–15) 5 (0–16)
P-value is significant at <0.05. HAD, Hospital Anxiety and Depression scale; SD, standard deviation; VAS, visual analogue scale; WOMAC, Western
Ontario McMaster osteoarthritis index.

this trial the effects of US and sham US on disability
were evaluated.
Depression is commonly associated with chronic
pain.37 Among older adults with OA, the prevalence of
depressive symptoms is high.38 In the literature, there
are studies about the relationship between depression
and pain, disability, and disease symptoms among
patients with knee OA.39,40 The HADS was constructed
by Zigmond and Snaith26 in 1983 as a quick way to mea-
sure symptoms on depression and generalized anxiety in
patients in non-psychiatric hospital clinics. The HADS is
a widely used, popular self-report measure that has been
translated into many languages and is used in a wide
variety of clinical populations.41 In the present study,
HADS was used to assess the degree of anxiety and
depressive symptoms and improvement was observed
for depression and anxiety scores in both groups but
there were no differences between groups after the treat-
ment. The effect of US therapy on psychological status
was not studied in knee OA to-date. Because of this rea-
son we also aimed to evaluate the effect of US therapy on
depression and anxiety scores in this study.

204 International Journal of Rheumatic Diseases 2012; 15: 197–206


There is no evidence to suggest that US therapy is
unsafe. In three trials no side-effects were reported, nei-
ther in the US nor in the control group.13,14,18 Simi-
larly, in this study no adverse events had occurred
during or after the US treatment periods, so therapeutic
US can be used safely in knee OA.
The present study has some limitations requiring
further discussion. First, both continuous US and
sham US were used while applying other physical
therapy agents. All patients had pain and it was not
ethical to treat the sham-US group without addi-
tional interventions, so other physical therapy inter-
ventions were applied to subjects in both groups.
The effect of US could be masked by the application
of superficial heat, interferential current, and exercise,
and it could not be excluded that other physiother-
apy modalities were provided in addition to US treat-
ment. Second, patients were evaluated at baseline
and at the end of the treatment sessions, so short-
term effectiveness of US was evaluated. Third, the
majority of the patients were women with the same
OA frequency, so a comparison between the male
and female sexes was not performed. Fourth, the
study sample was small, so future studies with larger
populations and both sexes are needed. The strength
of the present study is that this study has adequate
patient and physician blinding, and the characteristics
of the device and application of the US were well
reported. In the literature there is no study evaluating
the short-term effectiveness of US therapy on disabil-
ity and psychological status in patients with knee
OA.
In this double-blind and randomized study, marked
improvements in clinical parameters were obtained
with therapeutic US and sham US in patients with knee
OA. The results of the present study demonstrated no
differences between therapeutic US and sham US on
pain, stiffness, functional activity, walking time, disabil-
ity, and psychological status.
In conclusion, US therapy is a safe deep-heating
modality but use of US in addition to a conventional
physical therapy program seems to have no further sig-
nificant effect in people with knee OA. This result seems
to be in concordance with the findings of many other
studies. Long-term observation with larger samples
should be assessed in future research.
DISCLOSURE
The authors have no financial disclosures to declare and
no conflicts of interest to report.
International Journal of Rheumatic Diseases 2012; 15: 197–206
Therapeutic ultrasound in knee osteoarthritis
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