Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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GERD

Intervention / Treatment
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* Procedure: Osteopatic Manual Therapy (OMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosed Gastroesophigual Reflux Disease Known effect of anti-reflux medication Exclusion Criteria: Hiatus hernia ≥5 cm gastric ulcer cancer uncontrolled bacterial, viral, fungal or parasite infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The study is a RSP designed multicenter study with two interventional- and one response variable. The two-interventional variable were Number of OMTs and Interval in days between each treatment. The GERD variables were degrees of Heartburn, Chest pain, Acid in mouth, Epigastric pain and Thoracic pain. The response variable were percent reduction in sum of the GERD variables from baseline in 4 categories. Each of the two RSP designs consisted of three dose levels. Three GERD patients were allocated to the first design level given six OMT with five days' interval. Based on the results obtained from the first design level, five patients were subsequently included to the second design level. The number of OMT's and interval between each treatment was separately determined. Seven patients were included to the third design level and given number of OMT's and interval between treatments calculated based on results obtained from the second design level.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Number of Osteopatic Manual Therapy<br>Intervention: OMT. Osteopatic Manual treatment consisting of Thoracic spine, Diaphragm mobilisation, Traction of the cardia and posture correction. | Procedure: Osteopatic Manual Therapy (OMT)<br>* OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction.<br>|
| Experimental: Interval in days between each OMT<br>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. | Procedure: Osteopatic Manual Therapy (OMT)<br>* OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in sum of the five GERD score from baseline. | 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. | One week after last OMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Manual Therapy, Dose-response, Two-dimensional randomized response surface pathway design, OMT in treatment of GERD