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

Meddoc

Status: Completed

Conditions: GERD

Treatments: Procedure: Osteopatic Manual Therapy (OMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03568825

GERD_III_2016-936

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Number of Osteopatic Manual Therapy

Experimental group

Description:

Intervention: OMT. Osteopatic Manual treatment consisting of Thoracic spine, Diaphragm mobilisation, Traction of the cardia and posture correction.

Treatment:

Procedure: Osteopatic Manual Therapy (OMT)

Interval in days between each OMT

Experimental group

Description:

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.

Treatment:

Procedure: Osteopatic Manual Therapy (OMT)