A randomised trial of therapeutic ultrasound for chronic rhinosinusitis in adults with cystic fibrosis

Not Applicable

• Conditions: cystic fibrosis; chronic rhinosinusitis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12613000214730
• Lead Sponsor: Royal Prince Alfred Hospital, Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rhinosinusitis-specific quality of life, measured by the 22-item Sino-Nasal Outcomes Test (SNOT-22). [The primary timepoint will be at the end of the 2-week treatment period. This outcome will also be measured at other times as a secondary outcome (see below). ]