Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

NCT04420052 | Withdrawn

• 2 other identifiers: Osteonose2019-A02907-50
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Rhinosinusitis Chronic

Keywords

Osteopathic manipulative treatment; Non-allergic; rhinosinusitis; Chronic Disease; rhinitis; sinusitis; manual therapy; osteopathy; light touch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Sino-nasal Outcomes Test 22 (SNOT-22)

  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

  Interview will occur at day 180

• Sort term change in peak nasal inspiratory flow (PNIF)

  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)

  PNIF will be perform at day 0 (before treatment) and at day 180.

Study Arms (2)

OMT group

EXPERIMENTAL

Other: Osteopathic manipulative treatment

Placebo group

PLACEBO COMPARATOR

Other: Placebo manipulation

Interventions

Osteopathic manipulative treatment 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.

OMT group

Placebo manipulation OTHER

The osteopath will lay hands without movement on the nose, the throat and the thorax of patients. This procedure takes around 15 minutes.

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut des Hautes Etudes Osteopathiques de Nantes: lead

Study Sites (1)

Cabinet ORL du Maine

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Rhinosinusitis; Chronic Disease; Rhinitis; Sinusitis

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• sebastien cambier

  Institut des Hautes Etudes Osteopathiques de Nantes

  PRINCIPAL INVESTIGATOR

• maxime salmon, MsC

  Institut des Hautes Etudes Osteopathiques de Nantes

  STUDY DIRECTOR

• Marie Moreau

  Institut des Hautes Etudes Osteopathiques de Nantes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The care provider knows the assignment of patient. In order to know if the blinding was effective, at the end of each treatment, patient will have to tell if they were in the placebo or the OMT group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

FR (1)