None listed
Conditions
Brief summary
Research question: Does therapeutic ultrasound reduce the severity of rhinosinusitis in adults with cystic fibrosis (CF)? Methods: Adults with CF and chronic rhinosinusitis will be randomly allocated to receive ultrasound or sham ultrasound in a hospital outpatient clinic, 6 times in 2 weeks. The primary outcome will be the severity of rhinosinusitis symptoms, measured using the 22-item Sino-Nasal Outcome Test after the treatment period. Secondary outcome measures will be peak nasal inspiratory flow, lung function, global rating of change, a generic health-related quality of life questionnaire, medication use, and adverse events. Measurements will occur during and 6 weeks beyond treatment. Significance: This study will determine whether therapeutic ultrasound reduces rhinosinusitis symptoms in adults with CF to a clinically worthwhile extent and whether any effect extends beyond the treatment period. Growing evidence indicates that sinusitis seeds the lower respiratory tract with infection, so an effective rhinosinusitis treatment may also have respiratory benefits, which are crucial for people with CF. Ultrasound use has decreased since it was shown to be ineffective for many conditions. If the study shows ultrasound is effective for CF rhinosinusitis, physiotherapists’ apply their skills and this equipment to treat CF rhinosinusitis.
Interventions
Therapeutic ultrasound. Participants will receive ultrasound insonation over each mixillary sinus for 5 minutes at 1 MHz and 1 W/cm^2, and over each frontal sinus for 4 minutes at 1 MHz and 0.5 W/cm^2. This 18-minute treatment will be applied 6 times during a 2-week period.
Sponsors
Royal Prince Alfred Hospital, Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed