Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in peak nasal inspiratory flow (PNIF)
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •contraindication to spine manipulation
- •receiving other treatment for CRS during this study
- •being pregnant
- •being under legal protection
- •withdrawal of consent
结局指标
主要结局
Change in peak nasal inspiratory flow (PNIF)
时间窗: 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.
次要结局
- 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)
- long term change in peak nasal inspiratory flow (PNIF)(PNIF will be perform at day 0 (before treatment) and at day 180.)
- 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))