Clinical trial NCT04420052: Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis
Official title: Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rhinosinusitis Chronic
Keywords: Osteopathic manipulative treatment
Non-allergic
rhinosinusitis
Chronic Disease
rhinitis
sinusitis
manual therapy
osteopathy
light touch
Lead sponsor: Institut des Hautes Etudes Osteopathiques de Nantes
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (Comité de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 50
* Chronic rhinosinusitis diagnosed by ear, nose, and throat (ENT) specialist or general practitioner
* informed consent given
* registered under french social security system

Exclusion Criteria:

* contraindication to spine manipulation
* receiving other treatment for CRS during this study
* being pregnant
* being under legal protection
* withdrawal of consent

Primary outcomes:
measure: Change in peak nasal inspiratory flow (PNIF)
timeFrame: PNIF will be perform at day 0 (before treatment) and at day 30 (before treatment)
Secondary outcomes:
measure: Change in Sino-nasal Outcomes Test 22 (SNOT-22)
timeFrame: Patients will complete the questionnaire at baseline (day 0), day 30, day 60, day 90, day 120, day 150 and day 180 to assess the change over time
measure: Patient-reported experience of care
timeFrame: Interview will occur at day 180
measure: Sort term change in peak nasal inspiratory flow (PNIF)
timeFrame: PNIF will be perform at day 0 (before and after treatment), day 30 (before and after treatment)
measure: long term change in peak nasal inspiratory flow (PNIF)
timeFrame: PNIF will be perform at day 0 (before treatment) and at day 180.
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Cabinet ORL du Maine
Study officials:
affiliation: Institut des Hautes Etudes Osteopathiques de Nantes
name: sebastien cambier
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut des Hautes Etudes Osteopathiques de Nantes
name: maxime salmon, MsC
role: STUDY_DIRECTOR
affiliation: Institut des Hautes Etudes Osteopathiques de Nantes
name: Marie Moreau
role: STUDY_CHAIR
References: