Professional Documents
Culture Documents
Sinusitis Dengan Ultrasound
Sinusitis Dengan Ultrasound
Question: Is there any difference between the effect of therapeutic ultrasound and antibiotics (amoxicillin) on pain and
congestion for acute bacterial rhinosinusitis in the short-term? Is there any difference in patient satisfaction, preferred future
intervention, side-effects and relapses in the long-term? Design: A randomised trial with concealed allocation and intention-
to-treat analysis. Participants: 48 patients (6 dropouts) with clinically diagnosed acute bacterial rhinosinusitis in primary care.
Intervention: The experimental group received 4 consecutive days of ultrasound and the control group received a 10-day
course of antibiotics. Outcome measures: Pain and congestion around the nose and in the forehead and teeth were measured
on a 0–10 numeric rating scale at baseline, Day 4, and Day 21. Satisfaction, preferred future intervention, side-effects, and
relapses were measured one year later. Results: By Day 4, pain around the nose had decreased by 1.5 points out of 10 (95%
CI 0.6 to 2.5) more in the experimental group than the control group. There were no other differences in decrease in pain
and congestion between the groups at Day 4 or 21. At one year follow-up, the experimental group were more likely to prefer
ultrasound than the control group were to prefer antibiotics to manage a future episode (RR 2.75, 95% CI 1.19 to 7.91). There
were no other differences between the groups in terms of satisfaction with intervention, number of side-effects, or number of
relapses. Conclusion: The results of this study suggest that therapeutic ultrasound is a viable alternative to antibiotics in the
management of acute bacterial rhinosinusitis. Trial registration: NCT00934830. [Høsøien E, Lund AB, Vasseljen O (2010)
Similar effect of therapeutic ultrasound and antibiotics for acute bacterial rhinosinusitis: a randomised trial. Journal
of Physiotherapy 56: 27–32]
Key words: Acute sinusitis, Rhinosinusitis, Therapeutic ultrasound, Antibiotics, Intervention, Physiotherapy,
Randomized trial
Method
Design
A randomised trial was conducted in a primary care setting
in Norway. Participants were recruited from consecutive Figure 1. Ultrasound was applied to the shaded areas of
patients coming to a single general practice with sinusitis- the sinuses with small, circular movements continuously
like symptoms, where they were diagnosed by a physician for 10 minutes.
(AL). After collection of baseline measures, the participants
were randomly allocated to an experimental or a control group received a 10-day course of antibiotics. The outcomes
group. The allocation sequence was computer generated were all self-reports by the participants who along with the
in random permutated blocks of 6 or 8 and was concealed therapists were not blind to group allocation. However, the
from the recruiter and participants in sealed envelopes person analysing the data was blind to group allocation.
which were opened by a nurse. The experimental group Pain and congestion were measured at baseline, Day 4, and
received four consecutive days of ultrasound and the control Day 21. Day 4 coincided with the last day of ultrasound,
Lost to follow-up
Experimental group Control group
• pneumonia Lost to follow-up
• 10 min ultrasound • Antibiotics
(n = 1) • none
• 1/day x 4 days • 3/day x 10 days
Lost to follow-up
Control group Lost to follow-up
• did not return
• Antibiotics • none
questionnaire (n = 2)
• 3/day x 10 days
Lost to follow-up
Lost to follow-up
• did not return
• none
questionnaire (n = 3)
while Day 21 was 11 days after the end of the course of Outcome measures
antibiotics. Satisfaction with the intervention, preferred Pain and congestion around the nose and in the forehead
future intervention, side-effects and relapses were measured and teeth were measured on a numeric rating scale, where
one year later. 0 represented no pain/congestion and 10 represented the
Participants worst pain/congestion possible. Pain around the nose was
considered the primary outcome.
Patients with sinusitis-like symptoms were included if they
were over 15 years old and had one of the following: pain Satisfaction with intervention (Y/N), preferred intervention
when bending forward, headache, or pain in the teeth. to manage a future episode (same as allocated/opposite of
They must also have had purulent nasal secretion; ‘double allocated), number of side-effects, and number of relapses
worsening’, ie, worsening of symptoms within 10 days after were measured using a postal questionnaire.
initial improvement (Lindbaek and Hjortdahl 2002, Meltzer
et al 2004, Rosenfeld et al 2007a); and a bacterial infection Data analysis
as indicated by an increased number of granulocytes A change in pain of 2 points on an 11-point numeric rating
(neutrophils) relative to lymphocytes on white blood cell scale has been shown to represent a clinically important
count. They were excluded if they had had antibiotics or difference (Farrar et al 2003). To have 80% power to detect
allergy medication within the last three weeks, were allergic a between-group difference in pain around the forehead of
to antibiotics, or were pregnant. 2 points on an 11-point numeric rating scale, with alpha at
0.05 and assuming a SD of 2 points, 17 participants were
Intervention needed in each group. Considering the uncertainty of the
The experimental group received therapeutic ultrasounda at SD, to increase the likelihood of normally distributed data,
1.0 W/cm2 in continuous mode for 10 minutes each day for and to account for drop-outs, it was decided to recruit 48
four days. The transducer was moved constantly in small participants.
circular movements on both sides of the nose and over the
forehead, ie, over the sinuses (Figure 1). The same machine All participants with follow-up data were analysed
was used to deliver all ultrasound. according to their group allocation, ie, using an intention-
to-treat principle. Due to a low drop-out rate of 6% in the
The control group was prescribed antibiotics – 500 mg of short-term and 12% in the long-term, no attempt was made
amoxicillin three times a day for 10 days. to impute missing data. Between-group effects for pain
(–0.4 to 2.0)
(–0.4 to 2.0)
(–1.7 to 0.7)
(–1.5 to 1.0)
(–2.4 to 1.1)
one year follow-up were reported as relative risk (95% CI).
–0.5
–0.3
–0.6
Difference between groups
0.8
0.8
Results
Flow of participants, therapists, and centres
through the trial
Forty-eight patients with acute bacterial rhinosinusitis
Day 4 minus Day 1
(–2.5 to–0.6)
(–3.3 to 0.3)
(–1.3 to 0.9)
(–1.9 to 0.4)
(–1.6 to 1.0)
group to receive ultrasound and 24 to the control group to
receive antibiotics. In the short-term, there were 3 dropouts
–0.2
–0.3
–0.7
–1.5
–1.5
(2.7)
–4.3
–4.4
–3.4
–2.8
–4.7
(1.8)
(1.9)
(1.4)
Con
(2.3)
–3.9
–3.9
(2.4)
–3.6
–4.6
–3.4
(2.1)
(2.1)
Exp
(3.3)
–2.5
–3.0
–2.8
(1.5)
(1.6)
(1.7)
(1.7)
–1.5
–1.8
Con
(2.5)
(2.3)
(2.7)
–3.3
–3.5
–3.3
–2.8
–3.0
(1.6)
Exp
(0.5)
(0.9)
(0.9)
(0.8)
(1.0)
0.2
0.5
0.8
0.5
1.5
(1.3)
(1.6)
(1.7)
Exp
1.6
1.1
(1.8)
(1.9)
(1.7)
(2.1)
Con
2.3
2.3
3.0
2.4
1.5
(1.2)
(1.3)
(1.7)
Exp
2.6
1.9
1.0
1.7
1.7
(2.0)
(3.0)
(1.5)
(1.7)
Con
4.2
5.8
4.9
3.0
5.1
(2.2)
(2.3)
(2.5)
(3.4)
(2.1)
Exp
5.2
4.2
6.3
4.8
5.0
NRS (0 to 10)
Forehead
Forehead
Congestion
Nose
Table 3. Number of participants (%) in each group* for satisfaction, side-effects, relapse, and preferred future intervention,
and relative risk (95 % CI) between groups at one year.
CI 0.87 to 4.12). However, the experimental group were not been documented (Gwaltney et al 2004). Information
more likely to prefer ultrasound than the control group were on the clinical course of untreated sinusitis comes from
to prefer antibiotics for a future episode (RR 2.75, 95% CI patients receiving a placebo in randomised trials for acute
1.19 to 7.91). bacterial rhinosinusitis, but there are conflicting results.
Lindbæk et al (1996) reported a significantly faster and
Discussion superior effect of amoxicillin compared to placebo within
30 days of symptom onset. However, Rosenfeld et al (2007b)
Despite rapid and clinically significant reductions in facial reported improvement after seven days with and without
pain and congestion in both groups, there was little or no antimicrobial intervention and Bucher et al (2003) reported
difference between the effect of therapeutic ultrasound no advantage of antibiotics over placebo. Since no placebo
and antibiotics on pain and congestion in acute bacterial group was included in our study, we cannot distinguish
rhinosinusitis in the short-term, although a trend for a faster the effect of intervention from placebo. However, there is
effect for ultrasound was indicated by a larger decrease in some evidence for a superior effect of antibiotic compared
pain around the nose by Day 4. The experimental group to placebo within a window 7–12 days after initiating
were more likely to prefer ultrasound than the control intervention (Haye et al 1998, Rosenfeld et al 2007b).
group were to prefer antibiotics as an intervention for a
future episode of sinusitis, possibly reflecting a concern for The mechanism for a beneficial effect of ultrasound is
antibiotic resistance. Few side-effects were reported. Four unknown. Clinically, coloured and purulent discharge is
days were required to administer the ultrasound as opposed regularly observed during or immediately after intervention.
to 10 days for the course of antibiotics. Delivery of the Ultrasound works by transporting mechanical energy
ultrasound necessitated four visits to a professional whereas through local vibration of tissue particles (Leighton 2007).
prescription of the antibiotics only needed one attendance. Perhaps mechanical vibration detaches purulent matter
The direct costs are probably only marginally different. from the walls of the sinuses, independent of a viral or
bacterial cause, relieving the pressure and thus easing the
There are a number of potential causes of sinusitis (such pain. Bartley and Young (2009) point to enhanced bacterial
as bacteria, viruses, fungi, parasites, allergies) and there is death from low frequency, high intensity ultrasound in
lack of consensus on diagnostic criteria and classification laboratory settings. When bacteria density reaches a critical
(Benninger et al 2003). Distinguishing between viral and level they organize within ‘slimy’ biofilms for protection,
bacterial infection in the clinic is difficult (Hickner et a potential reason for the ineffectiveness of antibiotics.
al 2001, Young et al 2008) and we cannot rule out that Bartley and Young hypothesise that ultrasound may break
participants with viral infections or other causes of sinusitis down biofilms and that this could either kill or reduce
were included in our sample. However, symptom duration the viability of bacteria directly or make bacteria more
for most participants of above seven days suggests a accessible to antibiotic intervention by increasing cell
bacterial infection (Rosenfeld et al 2007a) and an increase of membrane permeability.
granulocytes (neutrophils) rather than lymphocytes favours
a bacterial rather than a viral infection (Table 1). This is, There is growing concern about resistance and overutilisation
however, only an indication and not conclusive evidence of of antibiotics for sinusitis-like symptoms in primary care.
a bacterial origin for acute bacterial rhinosinusitis. Imaging, By confirming that there is no difference between the effect
laboratory tests or bacterial culture are not recommended for of therapeutic ultrasound compared with antibiotics, except
routine use in primary care (Hickner et al 2001, Rosenfeld for a faster benefit in terms of pain around the nose, this
et al 2007a). The primary care clinician is thus left to base study provides evidence that ultrasound can be used as an
the diagnosis of acute bacterial rhinosinusitis on signs and alternative intervention to antibiotics for acute sinusitis.
symptoms seen in the clinic in line with the procedures Furthermore, therapeutic ultrasound had no serious side-
used in this study. effects. However, it should be kept in mind that both
interventions may have a marginal impact on the natural
We cannot say whether the rapid reduction of symptoms course of the disease. The combined effect of ultrasound
observed in both groups reflects an effect of intervention, and antibiotics for sinusitis should be investigated. n
placebo, or natural history. Natural history of sinusitis has
Footnote: aSonopuls 492, Enraf-Nonius BV, PO Box 12080, Hickner JM, Bartlett JG, Besser RE, Gonzales R, Hoffman JR,
3004, The Netherlands. Sande MA (2001) Principles of appropriate antibiotic use for
acute rhinosinusitis in adults: background. Annals of Internal
Ethics: The study was approved by the Regional Committee Medicine 134: 498–505.
for Medical and Health Research Ethics in Trondheim, Leighton TG (2007) What is ultrasound? Progress in Biophysics
Norway (2004). Written consent was obtained from all and Molecular Biology 93: 3–83.
participants before the study began. Lindbaek M (2004) Acute sinusitis: guide to selection of
antibacterial therapy. Drugs 64: 805–819.
Competing interests: None declared. Lindbaek M (2007) Acute sinusitis––to treat or not to treat?
JAMA 298: 2543–2544.
Support: Sør-Trøndelag chapter of the Norwegian
Physiotherapist Association for financial support. Lindbaek M, Hjortdahl P (2002) The clinical diagnosis of acute
purulent sinusitis in general practice––a review. British
Acknowledgements: Røros Medical Centre for assistance Journal of General Practice 52: 491–495.
in patient recruitment. Lindbaek M, Hjortdahl P, Johnsen UL (1996) Randomised,
double blind, placebo controlled trial of penicillin V and
Correspondence: Dr Ottar Vasseljen, Department of amoxycillin in treatment of acute sinus infections in adults.
Public Health and General Practice, Faculty of Medicine, British Medical Journal 313: 325–329.
Norwegian University of Science and Technology, Norway. Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF,
Email: ottar.vasseljen@ntnu.no Nicklas RA, et al (2004) Rhinosinusitis: establishing definitions
for clinical research and patient care. Otolaryngology–Head
and Neck Surgery 131: S1–S62.
References
Neumark T, Brudin L, Engstrom S, Molstad S (2009) Trends
Ahovuo-Saloranta A, Borisenko OV, Kovanen N, Varonen H, in number of consultations and antibiotic prescriptions
Rautakorpi UM, Williams JW Jr., et al (2008) Antibiotics for for respiratory tract infections between 1999 and 2005 in
acute maxillary sinusitis. Cochrane Database of Systematic primary healthcare in Kalmar County, Southern Sweden.
Reviews April 16: CD000243. Scandinavian Journal of Primary Health Care 27: 18–24.
Bartley J, Young D (2009) Ultrasound as a treatment for chronic Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D,
rhinosinusitis. Medical Hypotheses 73: 15–17. Eisenberg S, Ganiats TG, et al (2007a) Clinical practice
Benninger MS, Ferguson BJ, Hadley JA, Hamilos DL, Jacobs guideline: adult sinusitis. Otolaryngology–Head and Neck
M, Kennedy DW, et al (2003) Adult chronic rhinosinusitis: Surgery 137: S1–S31.
definitions, diagnosis, epidemiology, and pathophysiology. Rosenfeld RM, Singer M, Jones S (2007b) Systematic review
Otolaryngology–Head and Neck Surgery 129: S1–S32. of antimicrobial therapy in patients with acute rhinosinusitis.
Bucher HC, Tschudi P, Young J, Periat P, Welge-Luussen Otolaryngology–Head and Neck Surgery 137: S32–S45.
A, Zust H, et al (2003) Effect of amoxicillin-clavulanate Varonen H, Rautakorpi UM, Huikko S, Honkanen PO, Klaukka
in clinically diagnosed acute rhinosinusitis: a placebo- T, Laippala P, et al P (2004) Management of acute maxillary
controlled, double-blind, randomized trial in general practice. sinusitis in Finnish primary care. Results from the nationwide
Archives of Internal Medicine 163: 1793–1798. MIKSTRA study. Scandinavian Journal of Primary Health
Farrar JT, Berlin JA, Strom BL (2003) Clinically important Care 22: 122–127.
changes in acute pain outcome measures: a validation study. Varonen H, Rautakorpi UM, Nyberg S, Honkanen PO, Klaukka
Journal of Pain and Symptom Management 25: 406–411. T, Palva E, et al (2007) Implementing guidelines on acute
Ferech M, Coenen S, Malhotra-Kumar S, Dvorakova K, maxillary sinusitis in general practice––a randomized
Hendrickx E, Suetens C, et al (2006) European Surveillance controlled trial. Family Practice 24: 201–206.
of Antimicrobial Consumption (ESAC): outpatient antibiotic Williamson IG, Rumsby K, Benge S, Moore M, Smith PW,
use in Europe. Journal of Antimicrobial Chemotherapy 58: Cross M, et al (2007) Antibiotics and topical nasal steroid for
401–407. treatment of acute maxillary sinusitis: a randomized controlled
Gwaltney JM, Wiesinger BA, Patrie JT (2004) Acute community- trial. The Journal of the American Medical Association 298:
acquired bacterial sinusitis: the value of antimicrobial 2487–2496.
treatment and the natural history. Clinical Infectious Disease Young J, De SA, Merenstein D, van Essen GA, Kaiser L,
38: 227–233. Varonen H, Williamson I, et al (2008) Antibiotics for adults
Haye R, Lingaas E, Hoivik HO, Odegard T (1998) Azithromycin with clinically diagnosed acute rhinosinusitis: a meta-analysis
versus placebo in acute infectious rhinitis with clinical of individual patient data. Lancet 371: 908–914.
symptoms but without radiological signs of maxillary sinusitis.
European Journal of Clinical Microbiology and Infectious
Diseases 17: 309–312.