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Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

NCT04420052 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-01

No results posted yet for this study

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).

Conditions

  • Rhinosinusitis Chronic

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • Institut des Hautes Etudes Osteopathiques de Nantes

    lead OTHER

Principal Investigators

  • sebastien cambier · Institut des Hautes Etudes Osteopathiques de Nantes

  • maxime salmon, MsC · Institut des Hautes Etudes Osteopathiques de Nantes

  • Marie Moreau · Institut des Hautes Etudes Osteopathiques de Nantes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-06-01
Completion
2022-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420052 on ClinicalTrials.gov