Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

Rhinosinusitis Chronic Clinical Trial

Official title:

Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04420052
• Other study ID #: Osteonose
• Secondary ID: 2019-A02907-50
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2023
• Source: Institut des Hautes Etudes Osteopathiques de Nantes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinosinusitis Chronic
• Sinusitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Cabinet ORL du Maine	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Institut des Hautes Etudes Osteopathiques de Nantes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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.