Original Article J. Phys. Ther. Sci.

20: 233–238, 2008

A Clinical Trial on the Treatment of Chronic
Rhinosinusitis with Continuous Ultrasound

SOOFIA NAGHDI, PhD, PT1), NOUREDDIN NAKHOSTIN ANSARI, PhD, PT1),

MOHAMMAD FARHADI, MD2)
1)
Faculty of Rehabilitation, Tehran University of Medical Sciences, Iran: Enghelab Ave,
Pitch-e-shemiran, Zip: 11498, P.O.Box:11155-1683, Tehran-Iran.
TEL +98 21 7753 3939, FAX +98 21 7788 2009, E-mail: naghdi@sina.tums.ac.ir
2)
Research Center of Ear, Nose and Throat, Iran University of Medical Sciences, Iran

Abstract. [Purpose] Chronic rhinosinusitis is a common and long-term disease for which no definitive
treatment has been established. The purpose of this trial was to examine the effects of continuous
ultrasound on the treatment of patients with chronic maxillary and frontal sinusitis. [Subjects] Thirty adults
with chronic rhinosinusitis (24 men, 6 women; age range, 18–65 yrs; mean, 35.8 yrs) participated in the
study. [Methods] An interventional trial, pretest posttest study design was used. Subjects underwent
treatment for 10 sessions, three days per week. Patients were examined before and after treatment. Follow-
up questionnaires were sent to participants to assess changes in symptoms at 1 month posttreatment.
Therapeutic continuous ultrasound was applied through the cheeks and the forehead for the maxillary and
frontal sinuses, respectively. The primary outcome was the ‘percent improvement’. [Results] The patients
had a significant improvement post-treatment (mean, 74.37%). Following treatment, the severity of all
symptoms showed significant improvement (p<0.05). The beneficial effects of treatment were reported up
to one month after treatment ended, in terms of recurrence of the disease (72% of patients). [Conclusion]
This study showed that continuous ultrasound may be used as an effective modality for physiotherapy of
patients with chronic rhinosinusitis.
Key words: Chronic rhinosinusitis, Physiotherapy, Continuous ultrasound

(This article was submitted May 12, 2008, and was accepted Jul. 14, 2008)

INTRODUCTION life, can substantially impair function, and results in

Chronic rhinosinusitis (CRS), a common and
long-term condition, is a significant health
problem1). Newer classifications of sinusitis refer
to it as rhinosinusitis, because sinusitis cannot occur
without some inflammation of the nose (rhinitis)2).
Sinusitis represents a significant health and
socioeconomic problem, with 29.2 million adult
patients in the United States3, 4). It is estimated that
sinusitis accounts for more than 25 million office
visits to doctors in the United States each year5–7).
In 1996, the total costs were estimated at $5.8
billion annually2). CRS negatively affects quality of
reduced workplace productivity8, 9).
CRS is a prolonged or recurrent infection and/or
inflammation of the mucous membranes of the
sinuses and the mucous lining of the nose4, 10). The
etiology of CRS is multifactorial (e.g. viral, bacterial,
or fungal infection, allergy, and environmental
factors) and no effective treatment has been
established11). The definition of CRS is based on
symptoms and signs12): symptoms of inflammation
of the paranasal sinuses persisting more than 8–12
weeks or more than 3 or 4 acute episodes per year,
each lasting for at least 10 days13–15). The major
symptoms of sinusitis are facial pain/pressure, nasal
234 J. Phys. Ther. Sci. Vol. 20, No. 4, 2008
obstruction (blocakage), nasal discharge, purulence/
discolored post nasal drip (PND), hyposmia (smell
disturbance), purulence in the nasal cavity on
examination, and fever. Headaches, halitosis (bad
breath), fatigue, dental pain, cough, and ear pain
have been classified as the minor symptoms2). The
minor symptoms achieve diagnostic significance
when 1 or more of the major symptoms are present
among the symptoms 16) . Nasal obstruction or
posterior discharge is usually the main complaint in
patients with CRS8).
The treatment of CRS is often very difficult.
Poor blood circulation is one of the major factors
that contributes to medical failure and chronicity of
the disease17). A number of physiotherapy methods
have been reported to treat sinusitis. These consist
of postural drainage, cranial manipulation and
electrotherapy18). Both diathermy and
ultrasound19–21) have been suggested for treatment
of sinusitis. However, there is a dearth of
information about their efficacy. The first report by
Ansari et al.22) showed that CRS, was completely
resolved in a patient treated with pulsed ultrasound
(US). They concluded that US may be used as an
effective modality in chronic sinusitis. A further
report using a pretest-posttest research design
evaluated the effects of pulsed ultrasound on 57
patients with chronic sinusitis 23) . The results
showed a significant improvement in proportions of
CRS-related symptoms. In a randomized, single-
blind, placebo-controlled study, Ansari et al. (2007)
treated 20 patients with either continuous US (n=10)
or mock US (n=10), 3 days a week for 10 treatment
sessions24). They found that all patients improved
after treatment with US, and ‘percent improvement’
was significantly higher in the US group than in the
control group. At one-month follow-up, while CRS
had recurred in all patients of the control group,
eight patients in the US group reported no
recurrence of the disease. They concluded that
continuous US is an effective tool in the treatment
of patients with CRS, and recommended a further
larger study.
The aim of the present study was to examine the
effect of continuous US on the treatment of patients
with chronic rhinosinusitis. Our basic premise was
that treatment with continuous US can improve
CRS related symptoms.
SUBJECTS AND METHODS
Subjects
Patients were included if they had following
characteristics: age ≥ 18 years, three- month or
longer history of chronic sinusitis, and presence of
either two or more major symptoms, or one major
plus two minor symptoms. To verify the diagnosis
of chronic sinusitis, a complete history and coronal
computed tomographic scan (CT scan) were
obtained. Subjects were excluded if they were
currently under medical treatment for their
symptoms, or currently participating in another
clinical study. Those enrolled consisted largely of
patients who had received either multiple courses of
oral antibiotics, sinus washing or had undergone
sinus surgery, treatments which had not been
effective at relieving symptoms, and the disease
was refractory to other treatments.
Methods
A pretest-posttest design was chosen to determine
the effect of continuous ultrasound on patients with
CRS. All potential subjects were screened by a
physician, surgeon and specialist in ENT, for
inclusion in the trial. Only subjects who met the
selection criteria were included in the study. All
assessments during the study period, including
screening of patients, were made by a single
physician. The protocol was approved by the
Research Council of the Rehabilitation Faculty, and
subjects gave their informed consent to
participation.
For the study, a regular physiotherapeutic
ultrasound unit (Enraf Co, Sonopuls 434, model
901, The Netherlands) was used. The equipment
operates at frequencies of 1 and 3 MHz. The
circular plane applicator with a geometric area of
1.4 cm2 and an effective radiation area (ERA) of 0.8
cm2 was connected to the unit. The Beam Non-
uniformity Ratio (BNR) value was 5.0 max. The
technical US parameters were set as follows:
continuous mode with intensities of 1 W/cm2 and
0.5 W/cm2 for the maxillary and frontal sinuses,
respectively. The frequency was set to 1 MHz.
Duration of treatment was 5 minutes for each
maxillary sinus and 4 minutes for each frontal sinus
(total treatment time = 18 min). Area of treatment
was the cheeks and the forehead for the maxillary
and frontal sinuses, respectively. The volume of
adult maxillary and frontal sinuses is approximately
 235

15 ml (33×25×34 mm) and 6–7 ml (28×24×20 mm), Table 1. Demographics of patients

respectively 25) . The ultrasound applicator was Baseline characteristics n % Mean (SD)
moved in a circular technique, it was kept in slow (range)
continuous motion. Between the applicator and the Patients 30
skin, a US transmission gel (Sonogel, Germany) Age (yrs) 35.8 (12.33)
was used. On completion of the US treatment, the (18–65)
patient’s skin was cleaned of the gel. The treatment Gender, M/F 24/6 80/20
head was cleaned with alcohol. The ultrasound Duration of disease (month) 93.23 (73.48)
machine was calibrated by the manufacturer prior to (3–240)
Previous sinus surgery 5 16.7
the study and rechecked regularly during the
Frequency of septum deviation 15 50
survey. The accuracy of power output (W) and
intensity (W/cm2) was ± 5%.
The patients were treated three days per week, Table 2. Clinical data of patients
every other day for 10 treatment sessions. The US
Symptoms Mean SD Range
treatment was applied by one physiotherapist. The
physician, who examined the patients before and 4 Pre-treatment total score 5.50 2.36 1–11
weeks after treatment, assessed and recorded the Post-treatment total score 1.27 1.36 0–5
Percent improvement 74.37 27.73 0–100
outcome parameters. Patients were asked about
facial pain, PND, nasal obstruction (NO), nasal
discharge (ND), hyposmia and cough. Symptoms
were scored on an ordinal scale with the response (Pearson, p<0.0001). The results demonstrate the
alternatives: absent, mild, moderate, severe (and validity of the outcome measure used in this study,
recoded on a 0–3 scale). The values of the six in patients with CRS.
symptoms’ scores were added to obtain a total score One-month follow-up questionnaires were sent to
representing a ‘sinusitis symptom score’, with a all participants to assess changes in symptoms. The
score ranging from 0 (minimal symptoms) to 18 follow-up assessment was based on a 3-point scale
(maximal symptoms). (0–2) (0 = no recurrence; 1 = mild recurrence; 2 =
The percent improvement classification was used complete recurrence).
as the primary outcome variable (24): no change (0): The differences between values of pre- and post-
0 – 15%; poor (1): 16% – 35%; fair (2): 36% – 60%; treatment, and tests whether the average differs
good (3): 61% – 85%; excellent (4): 86% – 100%. from the null’ were calculated using the paired t-
This measure was obtained with reference to the test. All analyses were performed using SPSS,
range of total symptom scores obtained from V11.5. The level of significance was defined as
healthy subjects and rhinosinusitis patients (Walker p<0.05.
and White, 2000).
Validity of the outcome measure: The validity of RESULTS
the outcome measure was obtained against the
efficacy presented by Kamijyo et al. 13) . Five Of those who were screened, 30 patients (24 men
grades of improvement were assigned by and 6 women) with a mean age of 35.8 years (range:
comparing scores before and at the end of 18–65) and mean duration of disease of 93.23
treatment. Scores were assigned for each item as months (range: 3–240) completed the study (Table
follows: 4 points for disappearance, 3 points for 1).
good improvement, 2 points for fair improvement, In the study population (n = 30), maxillary
1 point for no change, and -4 points for worsening. sinuses were the most commonly involved sinuses
The average efficacy evaluation scores (X) were in the CT scan imaging (100%). In 23 of patients
calculated as follows: X= the total points for all (76.7%), maxillary sinuses were involved. The
items evaluated/the number of items assessed. The frontal and maxillary sinuses were both involved in
overall clinical efficacy was determined as: 16.7% of patients (n=5). One maxillary sinus was
Excellent: X>3; Good: 3≥X>2; Fair: 2≥X>1; Poor: involved in 2 of 30 (6.7%).
1≥X>0; Worse: 0≥X. The correlation between the Table 2 shows the clinical data of patients. The
“percent improvement”, and “X” value was 0.93 mean post-treatment total score was significantly
236 J. Phys. Ther. Sci. Vol. 20, No. 4, 2008

Table 3. The symptoms at pre- and post-treatment

Symptoms Frequency n (%) Mean (SD) range
p value
Pre Post Pre Post
Facial pain 25 (83.3) 7 (23.3) 1.83 (1.02) 0.33 (0.66) <.001
0-3 0-2
Post Nasal Drip 24 (80) 12 (40) 1.43 (1.04) 0.47 (0.68) <.001
0-3 0-3
Nasal Obstruction 15 (50) 6 (20) 0.77 (0.94) 0.23 (0.50) .003
0-3 0-2
Nasal Discharge 12 (40) 3 (10) 0.83 (1.21) 0.17 (0.59) .002
0-3 0-3
Smell disturbance 4 (13.3) 0 (0) 0.13 (0.35) 0 .043
0-1 0-0
Cough 11 (36.7) 2 (6.7) 0.5 (0.78) 0.07 (0.25) .005
0-3 0-1

better than the pre-treatment total score (1.27 vs
5.5). The reductions of total score were significant
after treatment with US (p<0.001).
Before treatment, the study patients most
commonly complained of facial pain (83.3%)
followed by PND (80%) and nasal obstruction
(50%) (Table 3). Following treatment, the severity
of all symptoms showed significant improvement
(p<0.05). The resolution of symptoms reported
most often were for hyposmia (100%), cough
(93.3%), nasal discharge (90%), nasal obstruction
(80%), facial pain (76.7%) and PND (60%).
Following treatment, the mean of percent
improvement was 74.37 (good) (Table 2). Thirteen
of thirty patients (43.3%) had an excellent
improvement (percent improvement: 85.71–100).
Excellent and good improvements were observed in
23 of 30 patients (76.7%) (percent improvement:
66.7–100). Six of patients (20%) had poor-fair
improvement (percent improvement: 25–50). Only
1 patient (3.3%) had no improvement after the
treatment (no change), and there were no reports of
negative effects from the treatment. Twenty-nine
patients (96.7%) improved after treatment with US.
Twenty-five patients returned the questionnaires.
Eighteen (72%) subjects reported no recurrence of
the disease at one month post treatment cessation.
The mild and complete recurrence of the disease
were found in three (12%) and four patients (16%),
respectively.
DISCUSSION
This study highlights that continuous US therapy
can improve symptoms of patients with CRS. This
is consistent with the only previous report showing
that for patients suffering from CRS, continuous US
is an effective modality24). Such improvement may
result primarily from tissue heating. By using
continuous US, greater heating occurs in the tissue.
Thus, given the poor blood circulation in the
sinuses16), increased regional blood flow could be
beneficial in reducing sinus inflammation24), and
significant resolution of the symptoms.
Another possible explanation for the
improvements obtained with continuous US could
be the mechanical effects 18) . Both heating and
mechanical effects of US are reported present
during treatment27, 28). The ostiomeatal complex
has a key role in normal sinus function. Blockage of
the sinus ostia due to inflammation of the mucosa
causes retention of secretions within the sinus
cavity which in turn may result in increased
inflammation and bacterial infection within the
cavity29). Mucosal damage disrupts normal ciliary
function of the sinus, as well16). In order to promote
recovery of CRS, drainage of the sinus is essential.
Therefore, we assume that the mechanical
vibrations of the US waves might have helped
drainage of the secretions23, 24).
The most frequent presenting symptom that
prompts patients to seek medical attention is facial
pain16). Considerable resolution of the facial pain
suggests continuous US is an effective option for
CRS-related pain. The resolution of the pain could
be a direct and/or indirect effect of US through
drainage of the secretions trapped in the sinus
cavity23, 24).
The recurrence of CRS in some patients may be
explained by the fact that such patients mostly had

septum deviation and/or previous surgery. The
septum deviation is a structural factor in the
development of CRS. After surgery, negative
factors including potential offending bacteria,
fungi, viruses, and the immunologic responses may
cause recurrence of the condition compounding
CRS 1) . Nevertheless, no patient reported that
symptoms of CRS had worsened. With regard to
the chronic and continued nature of the sinusitis, a
study with well-defined criteria and a longer follow-
up time is warranted.
In conclusion, we conclude that following
continuous US therapy the improvements in
patients with CRS were clinically significant, and
continuous US may be an effective modality of
physiotherapy for sinusitis. However, the use of a
single group for treatment has limited the results.
The results of a previous report using a placebo
group indicate that the trend in outcome scores is for
significant improvement of symptoms with
continuous US. Nevertheless, further investigations
with a randomized placebo-controlled design and
sufficient power to assess the efficacy of ultrasound
therapy in chronic rhinosinusitis are needed.
Another important issue to consider is whether the
improvements reported by the patients treated with
continuous US, compared with other interventions
such as drug therapy, are clinically significant. A
further trial is needed to compare the continuous
ultrasound therapy with other interventions.
ACKNOWLEDGEMENTS
The authors gratefully acknowledge the patients
who participated in this study.
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