GERD
Conditions
Keywords
Two-dimensional randomized response surface pathway design, Osteopathic Manual Therapy, OMT in treatment of GERD, Dose-response
Brief summary
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
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.
Interventions
PROCEDUREOsteopatic Manual Therapy (OMT)
OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction.
Sponsors
Meddoc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in sum of the five GERD score from baseline. | 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. |
Outcome results
None listed