Randomized Two-dimensional Between-patient Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose of Osteopathic Manual Therapy in Treatment of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Meddoc
- 入组人数
- 15
- 主要终点
- Percent reduction in sum of the five GERD score from baseline.
研究概览
简要总结
Response Surface Pathway (RSP) design was previously developed for dose-finding studies with one interventional and one response variable, but RSP to higher dimensions is requested. The aim of this study is to introduce and evaluate the RSP design with two interventional and one response variable exemplified by estimating Minimum Efficacy Dose (MED) of Osteopathic Manual Therapy (OMT) in treatment of gastroesophageal reflux disease (GERD).
详细描述
15 GERD patients, divided in three design-level with three, five and seven patients. The study was performed as a two-dimensional randomized, between-patient RSP designed multicenter study with two interventional- and one response variable. The interventional variables "Number of OMT's" and "Treatment Interval" with common response variable formed two independent one-dimensional randomized between-patient RSP studies. The response variable was the percent reduction in sum of the five GERD score from baseline. Three GERD patients were allocated on the first design level given six OMT with five days' interval. Based on results obtained in the first and second design level, five patients were included to the second design level and seven to the third.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosed Gastroesophigual Reflux Disease
- •Known effect of anti-reflux medication
排除标准
- •Hiatus hernia ≥5 cm
- •gastric ulcer
- •uncontrolled bacterial, viral, fungal or parasite infection.
研究组 & 干预措施
Number of Osteopatic Manual Therapy
Intervention: OMT. Osteopatic Manual treatment consisting of Thoracic spine, Diaphragm mobilisation, Traction of the cardia and posture correction.
干预措施: Osteopatic Manual Therapy (OMT) (Procedure)
Interval in days between each OMT
Intervention: OMT. The time between each OMT's is calculated by the study design. Each OMT intervantion consists of Thoracic spine and Diaphragm mobilisation, Traction of the cardia and Posture correction.
干预措施: Osteopatic Manual Therapy (OMT) (Procedure)
结局指标
主要结局
Percent reduction in sum of the five GERD score from baseline.
时间窗: One week after last OMT
The five GERD variables recorded at baseline and one week after the last treatment were degrees of "Heartburn", "Chest pain", "Acid in mouth", "Epigastric pain" and "Thoracic pain", each recorded on a 10 cm VAS. The response variables were percent reduction in sum of the five GERD variables from baseline.
次要结局
未报告次要终点