Treatment of chronic rhinosinusitis using low level laser: a single blind placebo controlled clinical trial

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RESEARCH REPORT
A pilot study into the effect of low-level laser therapy in
patients with chronic rhinosinusitis
Soofia Naghdi
1
, PhD, PT, Noureddin Nakhostin Ansari
1
, PhD, PT, Mojtaba Fathali
2
, MD,
Jim Bartley
3
, FRACS, Mitra Varedi
4
, BSc, PT and Roshanak Honarpishe
5
, BSc, PT
1
Assistant Professor, Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences,
Tehran, Iran
2
Surgeon and Specialist in Ear, Nose and Throat, School of Rehabilitation, Tehran University of Medical Sciences,
Tehran, Iran
3
Surgeon and Specialist in Ear, Nose and Throat, Institute of Biomedical Technologies, Auckland University of
Technology, Auckland, New Zealand
4
Currently MSc student in Physiotherapy, Department of Physiotherapy, School of Rehabilitation, Tehran University of
Medical Sciences, Tehran, Iran
5
Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran
ABSTRACT
Chronic rhinosinusitis (CRS) is a common inflammatory disease of the nose and paranasal sinuses that has a sig-
nificant impact on patients’quality of life. No study has examined the effectiveness of applying low-level laser
therapy (LLLT) locally over the sinuses in patients with CRS. The aim of this study was to evaluate the effect of
LLLT in patients with CRS. Fifteen adult patients with CRS participated in this pilot pretest–posttest clinical
study. Patients were treated with a 830-nm Ga-Al-As laser in continuous-wave mode at a power output of
30 mW and energy dose of 1 J.Laser irradiation was delivered on six points over each maxillary or frontal sinus
with 33 sec irradiation for each point and a total treatment duration of 198 sec for each sinus. Patients were
given LLLT three times per week for ten treatment sessions. Patients were asked to score their symptoms in accord-
ance with a four-point scale (0–3), and a total symptom score (TSS) for each patient was calculated. Percentage
improvement of TSS was considered as the primary outcome measure. TSS was calculated at baseline (T0), at
2 weeks (T1) and at 4 weeks (T2). The TSS was improved significantly at T1 (39%) and at T2 (46.34%). A large
effect size for LLLT was found (η
p
2
η
p
2
= 0.63). The therapeutic effect was sustained for a mean of 5 months. This
pilot study indicates that LLLT applied for 4 weeks improves symptoms in patients with CRS.
INTRODUCTION
Chronic rhinosinusitis (CRS) is an inflammatory
disease of the nose and paranasal sinuses with symp-
toms that persist for at least 12 weeks with no
symptom resolution despite adequate medical treat-
ment. “Rhinosinusitis”is the current preferred termi-
nology because sinus mucosa inflammation almost
always occurs with concomitant nasal inflammation.
Nevertheless, the terms rhinosinusitis and sinusitis
can be used interchangeably (Meltzer and Hamilos,
2011; Rosenfeld et al, 2007). CRS can have a signifi-
cant impact on patients’quality of life.
CRS symptoms, which are similar to those of acute
rhinosinusitis, may include a combination of nasal con-
gestion, purulent rhinorrhea, facial pain/pressure, post-
nasal drainage (PND), headache, anosmia (loss of
sense of smell), and cough (Slavin et al, 2005). CRS
appears to have a multifactorial etiology (Benninger
et al, 2003; Eccles, 2011; Marple et al, 2009); associ-
ations have also been found between CRS prevalence
and environmental factors (Hamilos, 2011). Bacterial
Address correspondence to Dr Soofia Naghdi, Department of Phy-
siotherapy, School of Rehabilitation, Tehran University of Medical
Sciences, Tehran, Iran. E-mail: naghdi@sina.tums.ac.ir
Accepted for publication 6 February 2013
Physiotherapy Theory and Practice, 29(8):596–603, 2013
Copyright © Informa Healthcare USA, Inc.
ISSN: 0959-3985 print/1532-5040 online
DOI: 10.3109/09593985.2013.775204
596
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biofilms have been hypothesized to have an important
role in the pathogenesis of CRS (Hunsaker and Leid,
2008; Payne, Borish, and Steinke, 2011; Smith,
Buchinsky, and Post, 2011). The overall consensus is
that CRS is an inflammatory disease (Kilty and Desro-
siers, 2008; Marple et al, 2009), and inflammation
from infectious and non-infectious factors plays a key
role in CRS pathogenesis (Eloy et al, 2011; Hamilos,
2000; Van Crombruggen et al, 2011).
Systemic antibiotics are often ineffective in the
treatment of bacterial biofilm infections (Harvey and
Lund, 2007; Kariyawasam and Scadding, 2011). In
the absence of anatomical obstruction, the current
evidence indicates that functional endoscopic sinus
surgery provides no additional benefit to that obtained
by medical treatment (Cherry and Li, 2008; Khalil
and Nunez, 2006). These CRS treatment difficulties
have led clinicians and researchers to explore new
therapeutic modalities such as therapeutic ultrasound
and laser therapy (Ansari, Naghdi, Farhadi, and Jalaie,
2007; Bartley and Young, 2009; Krespi and Kizhner,
2011; Nakhostin Ansari, Naghdi, and Farhadi, 2004;
Young, Morton, and Bartley, 2010).
Low-level laser therapy (LLLT) is one of the electro-
physical agents used in physiotherapy to treat a wide
range of pathologies (Bjordal, Lopes-Martins, Joensen,
and Iversen, 2010; Hashmi et al, 2010). Three proper-
ties of a laser light in comparison with other forms of
light are: 1) monochromacity; 2) collimation; and 3)
coherence. LLLT devices use helium–neon (HeNe),
and gallium–aluminum–arsenide (Ga-Al-As or Ga-As)
to emit a laser light. LLLT is a form of phototherapy
that delivers low-power (≤500 mW) coherent and colli-
mated beam of light of a single wavelength (Belanger,
2010). The photobiomodulation via photochemical
reactions that LLLT induces at a cellular level is referred
to as biostimulation or photobiology (Reddy, 2004).
The photobiomodulation effect of LLLT is attribu-
ted to non-thermal events. It involves the absorption of
photon radiation by chromophores such as cytochrome
coxidase within the mitochondria leading to release of
nitric oxide (NO), and an increase in ATP levels
(Karu, 1999; Karu, Pyatibrat, and Afanasyeva, 2005).
These events can lead to modulation of cell metabolism,
normalization of cell function, inflammation reduction,
pain relief, and tissue repair (Bjordal et al, 2006; Ferreira
et al, 2005; Karu, 1999). There is strong evidence that
LLLT used by physiotherapists has anti-inflammatory
effects (Bjordal, Lopes-Martins, Joensen, and Iversen,
2010). In a recent in vitro study, researchers demon-
strated that laser has bacterial biofilm treatment poten-
tial; a significant bacterial count reduction was
achieved in an animal model of acute bacterial rhinosi-
nusitis (Krespi, Kizhner, and Kara, 2009; Krespi et al,
2011). To our knowledge, only two studies to date
have evaluated the effectiveness of LLLT in treating
patients with sinusitis (Krespi and Kizhner, 2011;
Moustsen, Vinter, Aas-Andersen, and Kragstrup,
1991). Krespi and Kizhner (2011) used near-infrared
laser Illumination (NILI), with or without photoacti-
vated (PA) agents in managing symptomatic postsurgi-
cal patients with CRS. They used a 2-m long diffuser
fiber with an active illuminating tip to apply laser intern-
ally to the nasal passage and sinuses. NILI was effective
in managing CRS, and the therapeutic effect was main-
tained for at least 2 months. A Danish trial, which used
LLLT (Ga-Al-As laser, 30 mW/830 nm) for patients in a
general practice setting with acute sinusitis found no
statistical difference between laser and placebo groups
(Moustsen, Vinter, Aas-Andersen, and Kragstrup,
1991). In this pilot study, we attempted to identify the
effect of LLLT in patients with CRS refractory to
medical treatments, applying LLLT externally over the
maxillary and frontal sinuses.
METHODS
Study design
This study was designed as a pretest–posttest clinical
trial to evaluate the effects of LLLT in patients with
CRS. The study was approved by the Research
Council, School of Rehabilitation, and the Ethics
Committee of the Tehran University of Medical
Sciences (TUMS). All subjects gave informed
consent. All the patients were recruited and referred
for treatment at the physiotherapy clinic in the
School of Rehabilitation, TUMS, by a surgeon and
specialist in Ear, Nose, and Throat (ENT).
Participants
Patients ≥18 years of age who had symptoms compati-
ble with maxillary or frontal CRS, with or without
polyp formation, verified by positive CT findings,
and who had failed medical or surgical therapy were
included in the study. Exclusion criteria were: taking
drugs concurrently; or having a medical pathology
for which LLLT is contraindicated.
Outcome measures
The primary outcome measure was percent improve-
ment of the total symptom score (TSS; Meltzer
et al, 2006). Before and after treatment, patients
scored their symptoms (facial pain/pressure, head-
ache, nasal obstruction, nasal discharge, PND, smell
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disturbance, fatigue, cough, and overall discomfort) in
accordance with a four-point scale (0–3) correspond-
ing to none, mild, moderate, or severe. The scores ob-
tained for nine symptoms were summed to obtain a
‘Total Symptom Score’(TSS). The percent improve-
ment of the TSS was calculated as the total score pre-
treatment minus total score posttreatment divided by
total score pretreatment multiplied by 100. The
percent improvement of TSSs were classified as
follows: no change (0): 0–15%; poor (1): 16–35%;
fair (2): 36–60%; good (3): 61–85%; and excellent
(4): 86–100% (Ansari, Fathali, Naghdi, and Hasson,
2010; Ansari, Naghdi, and Farhadi, 2007; Ansari
et al, 2012; Naghdi, Ansari, and Farhadi, 2008). A
worsening of symptoms was indicated by negative
value.
Intervention
LLLT was performed by Ga-Al-As infrared diode
laser (Endolaser 476, Enraf Nonius, Netherland),
wavelength 830 nm, average power output of
30 mW, and energy dose of 1 J. The area of LLLT
application was the skin over the cheeks and the
forehead, for the maxillary and frontal sinuses,
respectively. A contact technique was used with
patients wearing laser safety goggles in a supine lying
position, and the laser beam was kept stationary and
perpendicular to the skin. Six points over each maxil-
lary or frontal sinus were determined (Figure 1). Laser
irradiation was delivered in continuous-wave mode
with 33 sec irradiation for each point and a total treat-
ment duration of 198 sec for each affected maxillary or
frontal sinus. The total energy applied to each affected
maxillary or frontal sinus per session was 6 J. The
LLLT was applied three times a week for ten treat-
ment sessions. One physiotherapist applied all laser
interventions.
Procedure
Before treatment, all patients were examined by an
ENT specialist to verify the diagnosis of CRS. At base-
line (T0, week 0), eligible patients were interviewed
for demographic data, and to score their symptoms
to calculate TSS. The assessment of symptom severity
was repeated after the end of five treatment sessions
(T1, week 2) and after the end of the treatment (T2,
FIGURE 1. Six points over each maxillary or frontal sinus for delivering low-level laser therapy.
598 Naghdi et al.
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week 4). In addition, participants were followed-up by
telephone monthly for 18 months. Patients were called
to ask whether their symptoms recurred (yes/no), and
when symptoms took place from the last treatment
session. Patients received no drug or other physiother-
apy intervention for the duration of the study and the
follow-up period.
The SPSS version 11.5 was used to analyze the data.
Descriptive statistics were calculated for demographic
and outcome variables. The effect of LLLT on TSS
was examined using repeated measures ANOVA.
Effect size was reported as partial eta-squared (η2
p). Wil-
coxon signed-rank test was used to analyze the effects of
LLLT on individual symptoms and to compare
symptom improvement classification at T1 and T2.
The alpha level of significance was set to p< 0.05.
RESULTS
Patient characteristics
Fifteen patients with CRS (M = 13; F = 2) with a
mean age of 38 years (standard deviation 9.6; range
20–52) completed the study protocol. The mean
disease duration from the CRS was 124.5 months
(SD 102.41; range 7–360). Four patients had a
septal deviation, 1 had asthma, 1 had asthma and
allergy, and 1 was smoker. All patients had had appro-
priate antibiotic and/or allergy treatment. Two of 15
patients had had endoscopic sinus surgery or antral
washout. Patients reported no side effects from LLLT.
Total symptom scores
Table 1 shows the TSSs pre- and posttreatment. The
percentage improvement of TSSs was 39.0% and
46.3% at T1 and T2, respectively. Manchly’s test of
sphericity indicated that the assumption of sphericity
was not violated (χ
2
= 5.619, p= 0.06). Repeated
measures ANOVA with sphericity showed that TSSs
were significantly different (F(2, 28) = 23.393,
p< 0.001, η2
p= 0.63). Post hoc tests using Bonfer-
roni revealed that there was a significant difference in
TSSs between T0 and T1 ( p= 0.01), T0 and T2
(p< 0.001), and T1 and T2 ( p= 0.039).
Symptom improvement
Before treatment (T0), the patients mainly com-
plained of nasal obstruction, PND, fatigue, and
overall discomfort (median score = 2). Facial pain/
pressure, nasal discharge, smell disturbance, and
cough were scored as mild (median score = 1;
Table 2).
At T1, the median scores for all symptoms except
overall discomfort were 0 or 1. The median score for
the overall discomfort was not changed. At the end of
treatment (T2), the median score for all symptoms
was scored 0 or 1. The severity of all symptoms was
reduced after LLLT (Table 2). Wilcoxon signed rank
test showed a significant improvement of symptoms at
T1 (2 weeks) for facial pain/pressure, nasal obstruction,
nasal discharge, PND, fatigue, and cough ( p< 0.05).
At the end of treatment (T2), the severity of all symp-
toms was reduced significantly ( p< 0.05; Table 2).
Between 2 and 4 weeks, anosmia ( p= 0.046) and
overall discomfort ( p= 0.01) were improved
significantly.
Symptom improvement classification
The frequency of good and excellent improvement at
T2 was twice than that at T1 (4 vs. 2). The fre-
quency of poor (5 vs. 2) and fair (5 vs. 8) improve-
ments was equal at T1 and T2. At T2, symptoms
were worsened in one patient (Table 3). The
median (interquartile range [IQR]) of symptom im-
provement classification at T1 and T2 was poor
(IQR 1–2) and fair (IQR 2–3), respectively. There
was no statistically significant difference at T1 and
T2 for improvement classifications (Wilcoxon
signed rank test, p= 0.15).
TABLE 1. Total symptom scores pre- and posttreatment.
Total symptom score Mean (SD) Range
Pretreatment (T0, week 0) 12.47 (5.90) 2–21
Posttreatment (T1, week 2) 7.40 (4.31) 0–16
Posttreatment (T2, week 4) 5.33 (2.87) 0–10
Percent improvement (T1, week 2) 39 (25.76) 0–100
Percent improvement (T2, week 4) 46.34 (44.80) -100 to 100
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Follow-up
At 18 months, two patients were lost to follow-up.
Symptom improvements after treatment completion
were sustained for a mean of 5 months (SD 4.3;
range 0.5–15 months).
DISCUSSION
This pilot study was performed to investigate the
effects of LLLT using a non-invasive technique in
patients with CRS. The results of the present study
suggest that patients had a significant improvement
in symptoms following LLLT. Both the TSS and
severity of individual symptoms significantly
improved. To the authors’knowledge, this is the first
study to examine the effectiveness of applying LLLT
locally over the sinuses in patients with persistent
CRS symptoms.
We did not measure laser power transmission to
assess the extent to whether Ga-Al-As laser penetrates
to the sinuses. With regard to the results obtained, we
may postulate that a percentage of LLLT reached the
treated sinuses. The penetration depth value (PDV),
the tissue depth at which the incident laser energy is
reduced to 37% of its original value, in human skin
is approximately 1.0 cm for Ga-Al-As laser (Kolari
and Airaksinen, 1988; Nussbaum, Baxter, and Lilge,
2003). The PDV through bone is unknown, but
Ga-Al-As laser radiation could potentially reach the
maxillary and frontal sinuses. Laser power trans-
mission and the extent to which the low-level laser
irradiation penetrates to the sinus mucosa need
further investigation.
In the present study, measuring changes in symptom
scores was the measure of efficacy, because the diagno-
sis and treatment of rhinosinusitis are in general pri-
marily symptom based (Fokkens et al, 2007; Marple
et al, 2009; Meltzer and Hamilos, 2011).
Moreover, clinical trials investigating the efficacy of
new treatments usually use symptom scoring systems
as the main outcome measure to evaluate efficacy, of
which changes in symptoms are key benefits for patients
(Eccles, 2011). Although a validated disease-specific
instrument is preferred; they are in English, and need
translation and culturally adaptation for non-English
speaking countries. Instead, the scoring of individual
symptoms, and TSS is suggested for efficacy
TABLE 2. Symptoms before and after low-level laser therapy.
Symptoms
Pretreatment (T0) Posttreatment (T1, week 2) Posttreatment (T2, week 4)
Median
(25th–75th)
percentile Median
(25th–75th)
percentile pvalue Median
(25th-75th)
percentile pvalue
Facial pain/pressure 1 0–200–1 0.03 0 0-0 0.02
Headache 0 0–300–1 0.06 0 0-0 0.04
Nasal obstruction 2 1–310–2 0.007 1 1-1 0.006
Nasal discharge 1 0–300–1 0.04 0 0-1 0.02
Post nasal drip 2 1–310–2 0.04 1 0-2 0.03
Smell problem 1 0–310–3 0.18 0 0-2 0.02
Fatigue 2 0–200–1 0.01 0 0-1 0.02
Cough 1 0–100–0 0.008 0 0-1 0.008
Overall discomfort 2 1–321–2 0.10 1 1-2 0.01
TABLE 3. Frequency of symptoms improvement classification.
Improvement classification
Time Worse
No change (0),
0–15%
Poor (1),
16–35%
Fair (2),
36–60%
Good (3),
61–85%
Excellent (4),
86-100% pvalue
T1∗0 3 5 5 1 1 0.15
T2∗10 2822
∗T1, after the end of five treatment sessions at 2 weeks.
∗T2, after the end of the treatment at 4 weeks.
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assessments (Meltzer et al, 2006). The TSS and per-
centage improvement classification system used in
this study have been shown to be valid when assessing
the efficacy of therapeutic ultrasound in patients with
CRS (Naghdi, Ansari, and Farhadi, 2008).
In the current study, a large effect size was obtained
for LLLT in treating patients with resistant CRS. The
severity of symptoms in terms of TSS and individual
symptom scores was significantly improved, which is
consistent with the successful results reported by
Krespi and Kizhner (2011). However, one of the
patients reported an exacerbation of his symptoms
after the end of the treatment. He developed an
upper respiratory tract infection while not taking anti-
biotics. In the study by Krespi and Kizhner (2011),
high energy, 500 J per side, was delivered internally,
which caused pain associated with heat. We applied
low laser energy per affected sinus per session of 6 J,
and no side effects were noted.
The TSS was significantly better at T2 compared
with that at T1. Also if “good”and “excellent”
improvements were used as cut-off responder
thresholds, the frequency of good and excellent im-
provements at T2 was twice than those at T1. These
findings indicate that 10 treatment sessions would
provide further improvements in patients with CRS.
Considering that the treatment of CRS is difficult
and recommendations made by the World Association
of Laser Therapy (WALT, 2010) for optimal treat-
ment effects, we recommend at least 10 treatment ses-
sions of LLLT for patients with CRS.
The results found in the present study are not in
agreement with those from the Danish trial (Moust-
sen, Vinter, Aas-Andersen, and Kragstrup, 1991).
The differences could be due to different diseases
(acute sinusitis vs. CRS), methodologies, outcome
measures, and energy dose. In comparison, the
present study considered clinical criteria as well as
CT scanning for sinusitis diagnosis. It is not clear
how the patients were diagnosed in the Danish
study. Patients with only pain over a sinus/sinuses in
the acute stage were included. As well, patients were
treated concurrently with antibiotics and nose drops.
In the present study, patients had chronic disease,
and no allergy drugs or antibiotics were prescribed.
In their study, outcome measures were pain improve-
ment, disease duration, and general well-being.
Moustsen, Vinter, Aas-Andersen, and Kragstrup
(1991) used the same wavelength but only irradiation
of a single point in each sinus (irradiation time on each
sinus 90 sec) and only three treatment sessions with
one to three days interval. More current authors
emphasize the need to irradiate most of the pathology,
irradiate large affected tissues at several points, and
have more repeated sessions to observe positive
clinical outcomes (Bjordal, Lopes-Martins, Joensen,
and Iversen, 2010). Recent optimal dose-finding
reviews of LLLT in the head and neck region
suggest that the optimal treatment parameters (e.g.,
dose per point, irradiation times, treatment frequency,
and interval between sessions) are important to
achieve meaningful results (Bjordal et al, 2011;
Chow, Johnson, Lopes-Martins, and Bjordal, 2009).
A limitation of our study was the lack of a control
group. However, the mean effect of LLLT was greater
than placebo (Bjordal, Couppe, and Ljunggren,
2001). The laser energy dose used in the present
study also demonstrated a greater beneficial clinical
effect than the placebo effect reported by Moustsen,
Vinter, Aas-Andersen, and Kragstrup (1991).
The mechanisms of LLLT are not fully under-
stood. The benefits obtained with LLLT may be
explained primarily by anti-inflammatory and anti-
bacterial disease-modulating mechanisms (Bjordal
et al, 2003; Krespi and Kizhner, 2011). A review
article has demonstrated that the LLLT modality has
anti-inflammatory effects, and the magnitude of the
anti-inflammatory effect is similar to that of non-
steroidal anti-inflammatory drugs (NSAIDs; Bjordal,
Lopes-Martins, Joensen, and Iversen, 2010). A
recent study found that LLLT has an anti-inflamma-
tory effect on Staphylococcus epidermidis similar to
dexamethasone (Ma et al, 2012). In patients with
CRS, an increased numbers of neutrophils have
been reported (Demoly et al, 1997). The release of
local inflammatory mediators (e.g., bradykinin, pros-
taglandins, and histamine) and cytokines cause CRS
symptoms (Eccles, 2011). Several animal studies
have shown a reduction in inflammatory cell infiltra-
tion after LLLT (Aimbire et al, 2008; Barbosa et al,
2008; Pessoa, Melhado, Theodoro, and Garcia,
2004). Recently, a review article concluded that
LLLT reduces the concentration of signal molecules
involved in the inflammatory response, and LLLT
can inhibit prostaglandin E2, tumor-necrosis factor-
α, cyclooxygenase-2, and interleukin 1 beta (Gao
and Xing, 2009). All these effects of LLLT are desir-
able for improving symptoms in patients with CRS.
The significant improvement of CRS-related symp-
toms is important considering that no drugs were
prescribed concurrently for the patients.
In a healthy population, the paranasal sinuses are
considered sterile (Abou-Hamad et al, 2009). Bacteria
have been shown to playa role in both the development
of and the exacerbation of CRS (Larson and Han,
2011). In an animal study, a NIR 940-nm diode laser
with diffuser fiber tip was compared with a combination
of laser 635-nm and methylene blue as a photosensiti-
zer in acute bacterial rhinosinusitis in rabbits. This
study demonstrated that both methods were effective
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and significant bacterial reduction up to 99.9% was
achieved (Krespi, Kizhner, and Kara, 2009). In
patients with CRS, two groups were treated with
NILI: group 1 was treated with a 940-nm laser and
group 2 was treated with a combination of a PA agent
and 810-nm laser (Krespi and Kizhner, 2011). They
showed a moderate bactericidal/bacterial inhibition
effect, and NILI of the sinuses with or without PA
was effective in patients with CRS (Krespi and
Kizhner, 2011). The in vitro study by Krespi et al
(2011) investigated the efficacy of Q-switched Nd-
YAG SW (shock wave) laser and a NIR diode laser in
disrupting biofilm and killing methicillin-resistant Sta-
phylococcus aureus, and showed that laser-generated SW
followed by NIR laser is capable of bacterial count
reduction by 88%. One possible mechanism in
improvement of CRS symptoms in this study could
be due to an anti-bacterial effect of LLLT.
Study limitations
There was no control group receiving no treatment or
sham laser. Patients may have improved because of a
placebo effect of laser. We suggest using a control
group for future studies. The sample sizewas also small.
CONCLUSIONS
In this pilot study on the effect of LLLT in patients
with CRS, a large effect size was revealed. There was
a statistically significant improvement in the primary
outcome measure of percentage improvement of
TSS at various time points within the 4-week interven-
tion. The large effect size indicates that LLLT can be
used for the improvement of symptoms in patients
with CRS. The clinical efficacy of LLLT in CRS
needs further investigation in a placebo-controlled
trial with a larger sample size.
Acknowledgments
The authors thank the patients. We also thank Mrs.
Kazhal Fathizade, physiotherapist, for the sinus
figure drawing.
Declaration of interest: The authors report no
conflicts of interest. The present study was funded
by the research deputy, TUMS (Grant no. 10635).
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