In adults with cystic fibrosis, what is the effect of therapeutic ultrasound versus sham ultrasound on rhinosinusitis-specific and general quality of life, nasal patency, lung function, perceived global change and medication use.

Royal Prince Alfred Hospital, Sydney Local Health District0 个研究点目标入组 56 人开始时间: 2013年2月22日最近更新: 2020年1月13日

适应症

试验速览

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•To participate in this study, a person must: be 18 years of age or older; have cystic fibrosis confirmed by genetic testing; be clinically stable, defined as a forced expiratory volume in one second (FEV1) within 10% of his/her best outpatient value in the past 6 months; be able to read, write and comprehend English; be able and willing to attend the outpatient department for all scheduled visits; have had at least 2 rhinosinusitis symptoms for at least the past 3 months; and have at least one objective sign of rhinosinusitis at the time of enrolment. The symptoms and signs are those defined by the European consensus statements (Fokkens 2007, 2012). The symptoms must include at least one of either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), with facial pain/pressure or reduction/loss of smell. The sign can be polyps, mucopurulent discharge primarily from middle meatus, or oedema/mucosal obstruction in middle meatus seen with simple anterior rhinoscopy, or changes in the ostiomeatal complex on CT, if available.

•A person will be ineligible to participate in this study if s/he: has significant malignant, neurological or musculoskeletal conditions; is unable to perform spirometry reproducibly; has hot-cold insensitivity over the sinuses; has had a lung transplant; has had polypectomy or sinus surgery in the past year; has had therapeutic ultrasound to the sinuses in the past 3 months, or has had non-routine antibiotics in the past 2 weeks. Non-routine antibiotics are defined as those taken for less than 3 months.

发起方

Royal Prince Alfred Hospital, Sydney Local Health District