Last reviewed · How we verify
NCT04420052
Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis
NA trial testing Osteopathic manipulative treatment in Rhinosinusitis Chronic. Withdrawn.
1 June 2022
Quick facts
| Lead sponsor | Institut des Hautes Etudes Osteopathiques de Nantes |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 July 2021 |
| Primary completion | 1 June 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Osteopathic manipulative treatment
- Placebo manipulation
Conditions studied
- Rhinosinusitis Chronic — all drugs for Rhinosinusitis Chronic →
Sponsor
Institut des Hautes Etudes Osteopathiques de Nantes
Who can join
Adults 18 to 50, any sex, with Rhinosinusitis Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04420052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Osteopathic manipulative treatment
Trials testing the same drug.
- NCT07161661 — Chronic Low Back Pain and Osteopathic Manipulation Treatment · NA · recruiting
- NCT06306742 — Open-label Placebo in Manual Therapy · Phase 2 · completed
- NCT05687214 — Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome · NA · completed
- NCT05018390 — Impact of Osteopathic Manipulative Treatment on Pursuit Eye Movements in Healthy Human Adults · NA · completed
- NCT04932278 — The Role of Osteopathic Manipulative Medicine in Recovery From Concussions · NA · terminated
Other Institut des Hautes Etudes Osteopathiques de Nantes trials
Trials by the same sponsor.
- NCT06695806 — Measurement of the Intolerance to Uncertainty in Osteopaths · enrolling by invitation
- NCT05785650 — Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation · unknown
- NCT05951218 — Effects of Inhibition Techniques Applied on Trigger Points of Supraspinatus Muscle on Echogenicity and Patients' Pain · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04420052 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut des Hautes Etudes Osteopathiques de Nantes
- Last refreshed: 1 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04420052.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing