Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis
-
- STATUS
- Recruiting
-
- participants needed
- 90
-
- sponsor
- Institut des Hautes Etudes Osteopathiques de Nantes
Summary
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 (Comit de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).
Description
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.
Details
| Condition | Rhinosinusitis Chronic |
|---|---|
| Age | 18years - 50years |
| Treatment | Osteopathic manipulative treatment, Placebo manipulation |
| Clinical Study Identifier | NCT04420052 |
| Sponsor | Institut des Hautes Etudes Osteopathiques de Nantes |
| Last Modified on | 16 February 2024 |
How to participate?
,
Send a message
Enter your contact details to connect with study team
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.