About this trial
This study is a prospective, randomized, placebo-controlled, double-blinded clinical study. The balloon sinuplasty treatment is compared to placebo effect in chronic or recurrent maxillary sinusitis. The purpose is to find out the efficacy of balloon sinuplasty of maxillary sinuses and the patients who get the best benefit from balloon sinuplasty. The investigators also want to find out if balloon sinuplasty of maxillary sinuses improves Eustachian tube dysfunction. The study is executed in the Department of Ear and Oral Diseases, Tampere University Hospital. 120 patients who have either recurrent acute or chronic rhinosinusitis without nasal polyposis and whose sinusitis is limited mainly into maxillary sinuses, are recruited in the study. The patients are allocated either into the chronic maxillary sinusitis (60 patients) or the recurrent maxillary sinusitis (60 patients) branch of the study. Then, the patients are consecutively randomized into two treatment groups in the proportion of 1 to 1: A) Balloon sinuplasty group and B) Placebo group. The treatment is performed according to the patient's group status and all the patients are followed 12 months postoperatively.
The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is going to be measured primarily with the Sino-Nasal Outcome Test (SNOT-22). In recurrent acute maxillary rhinosinusitis, the effect of balloon sinuplasty treatment will be measured primarily with the number of acute rhinosinusitis infections. Besides this, number of antibiotic treatments and sick leaves are inquired, Visual Analog Scale (VAS) and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) are used, rhinomanometry, Cone Beam Computed Tomography (CBCT), tympanometry, tubomanometry, nasal endoscopy and general evaluation of the patients clinical ORL-status are performed. Also pre- and postoperative biopsies are taken from the middle turbinates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients at least 18 years old and younger than 70 years old
Patients willing to participate in the study
Patients whose diseases fill the definitions of chronic or acute recurrent maxillary rhinosinusitis
Patients with chronic maxillary rhinosinusitis has not responded to a 3-month trial of topical corticosteroid treatment
Disqualifiers
Chronic rhinosinusitis with nasal polyps
Notable inflammation in the ethmoidal, sphenoidal or frontal sinuses along with maxillary sinusitis
Previous nasal surgery
Sinonasal tumor
Trial design
Parallel
Treatments tested in this trial
Balloon sinuplasty of maxillary sinuses
Procedure/SurgeryA shapeable tip of the balloon dilatation device (Entellus XprESS LoProfile; Stryker Corporation, Kalamazoo, Michigan, U.S.A.), with maxillary bending, is inserted into the maxillary sinus ostium. Then guided with the tip, a flexible balloon (6 mm x 20 mm) is gently inserted into the ostium and inflated up to 12 atm for 15 seconds. The dilatation is repeated one more time. The same procedure is performed for both maxillary sinuses.
Sham surgery
Procedure/SurgeryThe middle meatus is gently palpated with a curved suction tip (the tip is not connected to a suction unit). The curved suction tip is placed medial to the uncinate process. In order to create a better placebo effect, the operating doctor says: "Now inflate the balloon up to 12 atm for 15 seconds." After 15 seconds the doctor says: "Deflate the balloon." This is repeated one more time. Similar procedure is carried out on both sides.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 3 months
The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.
Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 6 months
The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.
Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 9 months
The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.
Change from baseline Sino-Nasal Outcome Test (SNOT-22) score at 12 months
The effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is measured primarily with the Sino-Nasal Outcome Test (SNOT-22). The Sino-Nasal Outcome Test (SNOT-22) is a patient-reported measure of outcome developed for use in chronic rhinosinusitis with or without nasal polyposis. It can be used to assess the impact of chronic rhinosinusitis on the patient's quality of life. It may also be used to measure the outcome of a surgical intervention (Hopkins et al. 2009). In this study, SNOT-22 translated in Finnish is used. The validation of the Finnish version has been made by the Finnish Medical Society Duodecim.
Secondary outcomes
Amount of sick leaves
The number of sick leaves during the last year, last 6 and last 3 months is asked preoperatively, focusing on the sick leaves that are caused because of chronic or recurrent rhinosinusitis. Also, the information about the postoperative sick leaves is collected during all the controls in order to find out whether the amount of sick leaves changes after the operation or not.
Number of antibiotic treatments needed
One way to estimate the effectiveness of balloon sinuplasty is to collect the data of antibiotic treatments. Especially in the cases of recurrent acute rhinosinusitis this is valid information. In this study, the number of antibiotic treatments during the last year, last 6 and last 3 months is checked from the Prescription Centre. Also, the information about the postoperative antibiotic treatments is collected during all the controls from the Prescription Centre in order to find out whether the amount of antibiotic treatments changes after the operation or not.
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
Eustachian tube dysfunction is a common condition which causes ear symptoms such as clogging and popping. The condition is also commonly associated with chronic sinusitis. The ETDQ-7 is a valid and reliable symptom score for use in adult patients with Eustachian tube dysfunction. It is a 7-item questionnaire which inquires patient´s ear symptoms. It is easily administered in the clinical setting and has minimal burden to respondents (McCoul et al. 2012). In this study ETDQ-7 is used to evaluate patient´s possible ear symptoms which refer to Eustachian tube dysfunction. Patients fill the ETDQ-7-questionnaire preoperatively and during all the controls.
Visual Analog Scale (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (Wewers and Lowe 1990). In this study, VAS is used to measure the symptoms of nasal obstruction, nasal discharge, facial pain/pressure and olfactory disorder. Patients report their symptoms preoperatively and during all the controls.
Other outcomes
Adverse events
Information about possible postoperative adverse events is asked and determined during the clinical post-operative visits at 3 and 12 months. The patients are asked about possible postoperative adverse events also in the web based electronic question forms which the patients fill at 6 and 9 months post-operative.
General evaluation of the patient and clinical ORL-status
Careful ORL-status is made preoperatively and during the postoperative visits at 3 and 12 months. Focus is on the nasal status and especially on the structure, abnormalities and other findings. Careful ear status is also performed because of the interest on the correlation between chronic rhinosinusitis and Eustachian tube dysfunction.
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