Does Visceral Manipulation Works in Treating Functional Dyspepsia?

International College of Osteopathic Medicine

Status and phase: Unknown; Phase 1

Conditions: Functional Dyspepsia

Treatments: Procedure: Visceral Manipulation; Drug: PPIs and/or Domperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT01021475

VM-01

Details and patient eligibility

About

The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy.

Null hypothesis is that VM does not influence FD symptoms.

Full description

50 patients with Functional Dyspepsia (FD) diagnosed by General Practitioners are randomized in two therapy group: 1) drug only group and 2) drug + Visceral Manipulation group. Group 1 receive drug therapy for 4 weeks, Group 2 receive drug therapy for 4 weeks and 4 Visceral Manipulation visits with weekly frequency (visit 1 at day 1 of drug therapy). FD symptoms are recorded with VAS at baseline and after 1 and 4 weeks of therapy, and after 8 weeks (4 weeks after the finish of all therapies).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Functional Dyspepsia

Exclusion criteria

• Diabetes Mellitus
• Mental disturbance
• Thyroid gland dysfunction
• Intestinal, liver and biliary tract disease
• Concurrent medications that could interact with GI function
• Positive Helicobacter Pylori status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Usual drug FD therapy + Visceral Manipulation

Experimental group

Treatment:

Procedure: Visceral Manipulation

Usual drug FD therapy

Active Comparator group

Treatment:

Drug: PPIs and/or Domperidone