Steam inhalation and Nasal Irrigation For recurrent Sinusitis
ISRCTN | ISRCTN88204146 |
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DOI | https://doi.org/10.1186/ISRCTN88204146 |
Secondary identifying numbers | Sponsor ref: RSO 3493 |
- Submission date
- 05/01/2009
- Registration date
- 27/02/2009
- Last edited
- 06/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paul Little
Scientific
Scientific
Primary Medical Care
University of Southampton
School of Medicine
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Phone | +44 (0)2380 241050 |
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p.little@soton.ac.uk |
Study information
Study design | Pragmatic randomised controlled 2 x 2 factorial trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | A primary care randomised controlled trial of nasal irrigation and steam inhalation for recurrent sinusitis |
Study acronym | SNIFS |
Study objectives | Sinusitis is caused by the retention of sinus secretions creating a favourable milieu for infectious agents. This may be caused by: 1. Obstruction or narrowing of the sinus ostia by oedema or anatomical variants 2. Mucociliary dysfunction 3. Altered mucous composition with decreased elasticity or increased viscosity Hypothesis: 1. Is nasal irrigation effective in reducing the symptoms of recurrent sinusitis? 2. Is steam inhalation effective in reducing the symptoms of recurrent sinusitis? 3. Is a combination of the two treatments more effective, of equal effectiveness or less effective than each of the individual treatments alone? |
Ethics approval(s) | Southampton & South West Hampshire Research Ethics Committee (B), 05/07/2007, ref: 07/Q1704/69 |
Health condition(s) or problem(s) studied | Sinusitis |
Intervention | 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 be provided to each subject and they will make their own buffered 2.0% saline irrigation solution every 1 to 2 days comprising 1 heaped teaspoon salt, on half teaspoon baking soda and 1 pint tap water. We have chosen this intervention based on the provisional evidence from the previous randomised controlled trial in primary care. Group 2. Daily steam inhalation. Subjects will be asked to inhale steam for 5 minutes per day by placing a towel over the head over a bowl of recently boiled water. This intervention is chosen for its wide availability and ease of use rather than a particular device such as rhinotherm. Group 3. Combined treatment group. Subjects will be asked to use both treatments daily, with nasal irrigation prior to steam. The feasibility phase will determine whether it is more feasible and acceptable for patients to do both interventions at the same time of day, and which order is preferable. Group 4. Control group. Normal care. |
Intervention type | Other |
Primary outcome measure | 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 outcome measures | 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 |
Overall study start date | 01/12/2008 |
Completion date | 10/07/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | Minimum of 220 and maximum of 316 |
Key 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. |
Key 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 |
Date of first enrolment | 01/12/2008 |
Date of final enrolment | 10/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Southampton
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
University of Southampton (UK)
University/education
University/education
c/o Dr Martina Dorward
Legal Services
Highfield
Southampton
SO17 1BJ
England
United Kingdom
Website | http://www.southampton.ac.uk |
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https://ror.org/01ryk1543 |
Funders
Funder type
Government
Programme Grants for Applied Research (ref: RP-PG-0407-10098)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 20/09/2016 | Yes | No | |
Results article | nested qualitative interview study results | 03/11/2017 | Yes | No |
Editorial Notes
06/11/2017: Publication reference added.
21/07/2016: Publication reference added.