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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


reduced workplace productivity8, 9).
Chronic rhinosinusitis (CRS), a common and CRS is a prolonged or recurrent infection and/or
long-term condition, is a significant health inflammation of the mucous membranes of the
problem1). Newer classifications of sinusitis refer sinuses and the mucous lining of the nose4, 10). The
to it as rhinosinusitis, because sinusitis cannot occur etiology of CRS is multifactorial (e.g. viral, bacterial,
without some inflammation of the nose (rhinitis)2). or fungal infection, allergy, and environmental
Sinusitis represents a significant health and factors) and no effective treatment has been
socioeconomic problem, with 29.2 million adult established11). The definition of CRS is based on
patients in the United States3, 4). It is estimated that symptoms and signs12): symptoms of inflammation
sinusitis accounts for more than 25 million office of the paranasal sinuses persisting more than 8–12
visits to doctors in the United States each year5–7). weeks or more than 3 or 4 acute episodes per year,
In 1996, the total costs were estimated at $5.8 each lasting for at least 10 days13–15). The major
billion annually2). CRS negatively affects quality of symptoms of sinusitis are facial pain/pressure, nasal
234 J. Phys. Ther. Sci. Vol. 20, No. 4, 2008

obstruction (blocakage), nasal discharge, purulence/ SUBJECTS AND METHODS


discolored post nasal drip (PND), hyposmia (smell
disturbance), purulence in the nasal cavity on Subjects
examination, and fever. Headaches, halitosis (bad Patients were included if they had following
breath), fatigue, dental pain, cough, and ear pain characteristics: age ≥ 18 years, three- month or
have been classified as the minor symptoms2). The longer history of chronic sinusitis, and presence of
minor symptoms achieve diagnostic significance either two or more major symptoms, or one major
when 1 or more of the major symptoms are present plus two minor symptoms. To verify the diagnosis
among the symptoms 16) . Nasal obstruction or of chronic sinusitis, a complete history and coronal
posterior discharge is usually the main complaint in computed tomographic scan (CT scan) were
patients with CRS8). obtained. Subjects were excluded if they were
The treatment of CRS is often very difficult. currently under medical treatment for their
Poor blood circulation is one of the major factors symptoms, or currently participating in another
that contributes to medical failure and chronicity of clinical study. Those enrolled consisted largely of
the disease17). A number of physiotherapy methods patients who had received either multiple courses of
have been reported to treat sinusitis. These consist oral antibiotics, sinus washing or had undergone
of postural drainage, cranial manipulation and sinus surgery, treatments which had not been
electrotherapy18). Both diathermy and effective at relieving symptoms, and the disease
ultrasound19–21) have been suggested for treatment was refractory to other treatments.
of sinusitis. However, there is a dearth of
information about their efficacy. The first report by Methods
Ansari et al.22) showed that CRS, was completely A pretest-posttest design was chosen to determine
resolved in a patient treated with pulsed ultrasound the effect of continuous ultrasound on patients with
(US). They concluded that US may be used as an CRS. All potential subjects were screened by a
effective modality in chronic sinusitis. A further physician, surgeon and specialist in ENT, for
report using a pretest-posttest research design inclusion in the trial. Only subjects who met the
evaluated the effects of pulsed ultrasound on 57 selection criteria were included in the study. All
patients with chronic sinusitis 23) . The results assessments during the study period, including
showed a significant improvement in proportions of screening of patients, were made by a single
CRS-related symptoms. In a randomized, single- physician. The protocol was approved by the
blind, placebo-controlled study, Ansari et al. (2007) Research Council of the Rehabilitation Faculty, and
treated 20 patients with either continuous US (n=10) subjects gave their informed consent to
or mock US (n=10), 3 days a week for 10 treatment participation.
sessions24). They found that all patients improved For the study, a regular physiotherapeutic
after treatment with US, and ‘percent improvement’ ultrasound unit (Enraf Co, Sonopuls 434, model
was significantly higher in the US group than in the 901, The Netherlands) was used. The equipment
control group. At one-month follow-up, while CRS operates at frequencies of 1 and 3 MHz. The
had recurred in all patients of the control group, circular plane applicator with a geometric area of
eight patients in the US group reported no 1.4 cm2 and an effective radiation area (ERA) of 0.8
recurrence of the disease. They concluded that cm2 was connected to the unit. The Beam Non-
continuous US is an effective tool in the treatment uniformity Ratio (BNR) value was 5.0 max. The
of patients with CRS, and recommended a further technical US parameters were set as follows:
larger study. continuous mode with intensities of 1 W/cm2 and
The aim of the present study was to examine the 0.5 W/cm2 for the maxillary and frontal sinuses,
effect of continuous US on the treatment of patients respectively. The frequency was set to 1 MHz.
with chronic rhinosinusitis. Our basic premise was Duration of treatment was 5 minutes for each
that treatment with continuous US can improve maxillary sinus and 4 minutes for each frontal sinus
CRS related symptoms. (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 is consistent with the only previous report showing
5.5). The reductions of total score were significant that for patients suffering from CRS, continuous US
after treatment with US (p<0.001). is an effective modality24). Such improvement may
Before treatment, the study patients most result primarily from tissue heating. By using
commonly complained of facial pain (83.3%) continuous US, greater heating occurs in the tissue.
followed by PND (80%) and nasal obstruction Thus, given the poor blood circulation in the
(50%) (Table 3). Following treatment, the severity sinuses16), increased regional blood flow could be
of all symptoms showed significant improvement beneficial in reducing sinus inflammation24), and
(p<0.05). The resolution of symptoms reported significant resolution of the symptoms.
most often were for hyposmia (100%), cough Another possible explanation for the
(93.3%), nasal discharge (90%), nasal obstruction improvements obtained with continuous US could
(80%), facial pain (76.7%) and PND (60%). be the mechanical effects 18) . Both heating and
Following treatment, the mean of percent mechanical effects of US are reported present
improvement was 74.37 (good) (Table 2). Thirteen during treatment27, 28). The ostiomeatal complex
of thirty patients (43.3%) had an excellent has a key role in normal sinus function. Blockage of
improvement (percent improvement: 85.71–100). the sinus ostia due to inflammation of the mucosa
Excellent and good improvements were observed in causes retention of secretions within the sinus
23 of 30 patients (76.7%) (percent improvement: cavity which in turn may result in increased
66.7–100). Six of patients (20%) had poor-fair inflammation and bacterial infection within the
improvement (percent improvement: 25–50). Only cavity29). Mucosal damage disrupts normal ciliary
1 patient (3.3%) had no improvement after the function of the sinus, as well16). In order to promote
treatment (no change), and there were no reports of recovery of CRS, drainage of the sinus is essential.
negative effects from the treatment. Twenty-nine Therefore, we assume that the mechanical
patients (96.7%) improved after treatment with US. vibrations of the US waves might have helped
Twenty-five patients returned the questionnaires. drainage of the secretions23, 24).
Eighteen (72%) subjects reported no recurrence of The most frequent presenting symptom that
the disease at one month post treatment cessation. prompts patients to seek medical attention is facial
The mild and complete recurrence of the disease pain16). Considerable resolution of the facial pain
were found in three (12%) and four patients (16%), suggests continuous US is an effective option for
respectively. CRS-related pain. The resolution of the pain could
be a direct and/or indirect effect of US through
DISCUSSION drainage of the secretions trapped in the sinus
cavity23, 24).
This study highlights that continuous US therapy The recurrence of CRS in some patients may be
can improve symptoms of patients with CRS. This explained by the fact that such patients mostly had
237

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