Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

NCT ID: NCT04420052

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-06-30

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.

Conditions

Rhinosinusitis Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OMT group

Group Type: EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type: OTHER

Osteopaths will executed several high velocity low amplitude (HVLA) techniques on the upper thoracic spine and cervical spine. These techniques are assumed to modulate the sympathetic cervical ganglia and reduce inflammation in chronic rhinosinusitis.

This procedure takes around 15 minutes.

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo manipulation

Intervention Type: OTHER

The osteopath will lay hands without movement on the nose, the throat and the thorax of patients.

This procedure takes around 15 minutes.

Interventions

Osteopathic manipulative treatment

Osteopaths will executed several high velocity low amplitude (HVLA) techniques on the upper thoracic spine and cervical spine. These techniques are assumed to modulate the sympathetic cervical ganglia and reduce inflammation in chronic rhinosinusitis.

This procedure takes around 15 minutes.

Intervention Type: OTHER

Placebo manipulation

The osteopath will lay hands without movement on the nose, the throat and the thorax of patients.

This procedure takes around 15 minutes.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut des Hautes Etudes Osteopathiques de Nantes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

sebastien cambier

Role: PRINCIPAL_INVESTIGATOR

Institut des Hautes Etudes Osteopathiques de Nantes

maxime salmon, MsC

Role: STUDY_DIRECTOR

Institut des Hautes Etudes Osteopathiques de Nantes

Marie Moreau

Role: STUDY_CHAIR

Institut des Hautes Etudes Osteopathiques de Nantes

Locations

Cabinet ORL du Maine

Le Mans, , France

Countries

France

Other Identifiers

2019-A02907-50

Identifier Type: OTHER

Identifier Source: secondary_id

Osteonose

Identifier Type: -

Identifier Source: org_study_id