Sinusitis Ear, Nose and Throat Chronic sinusitis
Conditions
Interventions
Treatment and follow-ups will be for a 6-month period.
Group 1. Daily nasal irrigation. Subjects will be asked to irrigate the nose (150 ml through each nostril) daily for 6 months. A neti pot will
Sponsors
University of Southampton (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (both males and females) aged 18-65 years with recurrent or chronic sinusitis. Patients will be identified from GPs' computerised notes: those who have presented to their GP with 2+ episodes of acute or 1+ episode of chronic sinusitis in the last 3 years, who report moderate to severe impact of sinusitis symptoms on the quality of life.
Exclusion criteria
Exclusion criteria: 1. Inability to complete outcome measures 2. Head and neck cancer 3. HIV 4. Immunosuppressive treatment 5. Cystic fibrosis 6. Pregnancy/breastfeeding 7. Other nasal disorders e.g., polyps or other defect obstructing sinus 8. Poor gag or swallow reflexes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of symptoms assessed by the Rhinosinusitis Disability Index (RSDI). During the feasibility stage RSDI and Sino-Nasal Outcome Test-20 (SNOT-20) will be recorded. Both are validated self-completion outcome measures for sinusitis. RSDI was used for the previous primary care study. It is anticipated that RSDI will be the primary outcome measure for this trial. However, if SNOT-20 is shown in the feasibility stage to be more sensitive to change it will be adopted as the primary outcome measure. Timepoints of assessment: 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| From self-completion questionnaires at baseline, 3 and 6 months: 1. Quality of life assessed by the EQ-5D 2. Severity of sinus symptoms assessed by a Single-Item Sinus-Symptom Severity Assessment (SIA) 3. Severity of upper respiratory symptoms (coryza, sore throat, cough, earache, feeling unwell, fever) using format previously validated by our group 4. Belief in the importance of antibiotics and seeing the doctor for sinusitis using validated Likert scales From a daily diary for one week of the study period at 3 months: 5. Side effects of treatment (and also reported side effects for previous 3 months) 6. Compliance with irrigation/inhalation (to minimise reporting bias, patients will be given 'permission' not to perform the intervention) 7. Use of over the counter treatments (e.g., analgesics, decongestants) From notes review at the end of the follow-up period (at 6 months): 8. Number of prescriptions for antibiotics for sinus-related symptoms 9. Number of prescriptions for antibiotics in total 10. Number of GP visits regarding sinus-related symptoms and for other respiratory symptoms | — |
Countries
United Kingdom
Outcome results
None listed