Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

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).

Study Overview

• Status: Withdrawn
• Conditions: Rhinosinusitis Chronic
• Intervention / Treatment: Other: Osteopathic manipulative treatment; Other: Placebo manipulation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime Salmon; Phone Number: +332 28 07 29 28; Email: msalmon@idheo.com

Study Locations

• France
  • Le Mans, France, 72000
    • Cabinet ORL du Maine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	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.
Experimental: OMT group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak nasal inspiratory flow (PNIF)	The aim of this outcome is to measure change in nasal airflow during maximal inspiration with a facial mask.	PNIF will be perform at day 0 (before treatment) and at day 30 (before treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sino-nasal Outcomes Test 22 (SNOT-22)	This is a symptom-based rhinosinusitis questionnaire. Possible total scores range from 0 to 110, where a higher score indicates worse symptoms.	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
Patient-reported experience of care	Individual interviews will enable to document the personal experience during effective or placebo treatment.	Interview will occur at day 180
Sort term change in peak nasal inspiratory flow (PNIF)	The aim of this outcome is to measure change before and after each treatment in nasal airflow during maximal inspiration with a facial mask.	PNIF will be perform at day 0 (before and after treatment), day 30 (before and after treatment)
long term change in peak nasal inspiratory flow (PNIF)	The aim of this outcome is to measure change in nasal airflow during maximal inspiration with a facial mask from base line to day 180.	PNIF will be perform at day 0 (before treatment) and at day 180.

Collaborators and Investigators

• Sponsor: Institut des Hautes Etudes Osteopathiques de Nantes
• Investigators: Principal Investigator: sebastien cambier, Institut des Hautes Etudes Osteopathiques de Nantes; Study Director: maxime salmon, MsC, Institut des Hautes Etudes Osteopathiques de Nantes; Study Chair: Marie Moreau, Institut des Hautes Etudes Osteopathiques de Nantes

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2021
• Primary Completion (Estimated): June 1, 2022
• Study Completion (Estimated): June 30, 2022

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 29, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: manual therapy; Chronic Disease; osteopathy; sinusitis; rhinitis; rhinosinusitis; Osteopathic manipulative treatment; Non-allergic; light touch
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: Osteonose; 2019-A02907-50 (Other Identifier: Agence nationale de sécurité du médicament et produits de santé)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No