Rhinosinusitis Chronic Clinical Trial
Official title:
Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial
Chronic Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options. Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by applying several techniques supposed to be related to the autonomic nervous system. Our hypothesis is that these techniques could have beneficial effects on inflammation and head symptoms in CRS. Methods: A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT group or the placebo group. The placebo procedure will consist in using light touch around the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of two visits at day 0 and day 30. A general practitioner will determine the eligibility for the study. The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30 (twice each, before and after treatment) and 180 (once). The two groups will be compared regarding short and long term evolution. The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed effect modelling A Qualitative study will be conducted in the two groups to understand the patients' experiences during care. This protocol has been approved by a french ethic committee (Comité de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).
Statistical analysis details: PNIF middle term evolution: If the two groups can be compared regarding their socio-demographics characteristics, a student's t-test will compare evolution (day 0 before treatment to day 30 before treatment) of the PNIF between groups. If characteristics are different, a multivariate linear model will be applied. PNIF long term evolution: The same tests will be made. The evolution will be assessed between day 0 (before treatment) and day 180. PNIF short term evolution: The same tests will be made. The evolution will be assessed before and after treatment at day 0 and day 30. SNOT-22 evolution: Mixed effect model will assess the evolution of symptoms from day 0 to day 180 Response Shift detection: For the SNOT-22, an Oort procedure will be performed in order to detect Response shift among individuals. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05923047 -
Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
|
Phase 4 | |
Not yet recruiting |
NCT05836935 -
Role of Imaging in Complications of Sinusitis
|
N/A | |
Not yet recruiting |
NCT05167552 -
Treatment of Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells
|
Phase 1/Phase 2 | |
Completed |
NCT04703673 -
Sinolpan® Pharmacy Non-interventional Study - Quality of Live
|
||
Recruiting |
NCT05639686 -
TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality
|
N/A | |
Recruiting |
NCT05015530 -
Impact of Symbiofilm On Nasal Microbiota
|
||
Not yet recruiting |
NCT06105346 -
Prevalence of ENT Diseseas
|
||
Recruiting |
NCT05450471 -
Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis
|
Phase 3 | |
Terminated |
NCT03675022 -
Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis
|
Early Phase 1 |