Rhinosinusitis ChronicNCT04420052
Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis
A study testing Osteopathic manipulative treatment in people with Rhinosinusitis Chronic, run by Institut des Hautes Etudes Osteopathiques de Nantes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rhinosinusitis Chronic
- What is being tested?
- Osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- contraindication to spine manipulation
- receiving other treatment for CRS during this study
- being pregnant
- being under legal protection
- withdrawal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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).
Read the 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
- Being tested
- Osteopathic manipulative treatment, Placebo manipulation
- Keywords
- Osteopathic manipulative treatment, Non-allergic, rhinosinusitis, Chronic Disease, rhinitis, sinusitis, manual therapy, osteopathy, light touch
- Medical subject headings
- Rhinosinusitis, Chronic Disease, Rhinitis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentOther
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 manipulationOther
The osteopath will lay hands without movement on the nose, the throat and the thorax of patients.
This procedure takes around 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| OMT group | Experimental | Not described Receives: Other: Osteopathic manipulative treatment |
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
This is a symptom-based rhinosinusitis questionnaire. Possible total scores range from 0 to 110, where a higher score indicates worse symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: PNIF will be perform at day 0 (before treatment) and at day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Why it stopped: COVID, death of investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinosinusitis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de Nantes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sebastien cambier, Principal investigator, Institut des Hautes Etudes Osteopathiques de Nantesmaxime salmon, MsC, Study director, Institut des Hautes Etudes Osteopathiques de NantesMarie Moreau, Study chair, Institut des Hautes Etudes Osteopathiques de Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420052
- Sponsor's protocol ID
- Osteonose
- Other IDs
- 2019-A02907-50
- Status last verified
- Jul 2023
- First submitted
- 28 May 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04420052
- Acronym / sponsor ID
- Osteonose
- Conditions
- Rhinosinusitis Chronic
- Keywords
- Osteopathic manipulative treatment, Non-allergic, rhinosinusitis, Chronic Disease, rhinitis, sinusitis, manual therapy, osteopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID, death of investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut des Hautes Etudes Osteopathiques de NantesUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT group | Experimental | Other: Osteopathic manipulative treatment |
| Placebo group | Placebo comparator | Other: Placebo manipulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- contraindication to spine manipulation
- receiving other treatment for CRS during this study
- being pregnant
- being under legal protection
- withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manipulative treatmentOsteopaths 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 | OMT group |
| Placebo manipulationThe osteopath will lay hands without movement on the nose, the throat and the thorax of patients. This procedure takes around 15 minutes. | Other | Placebo group |
Primary outcome
Change in peak nasal inspiratory flow (PNIF)
Time frame: PNIF will be perform at day 0 (before treatment) and at day 30 (before treatment)
The aim of this outcome is to measure change in nasal airflow during maximal inspiration with a facial mask.
4 secondary outcomes
Change in Sino-nasal Outcomes Test 22 (SNOT-22)
Time frame: 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
Time frame: Interview will occur at day 180
Sort term change in peak nasal inspiratory flow (PNIF)
Time frame: 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)
Time frame: PNIF will be perform at day 0 (before treatment) and at day 180.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Related trials for Rhinosinusitis Chronic
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Not yet recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sebastien cambier principal investigator
Institut des Hautes Etudes Osteopathiques de Nantes
maxime salmon, MsC study director
Institut des Hautes Etudes Osteopathiques de Nantes
Marie Moreau study chair
Institut des Hautes Etudes Osteopathiques de Nantes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative treatment in people with Rhinosinusitis Chronic, run by Institut des Hautes Etudes Osteopathiques de Nantes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak nasal inspiratory flow (PNIF) (time frame: PNIF will be perform at day 0 (before treatment) and at day 30 (before treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.