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Does Visceral Manipulation Works in Treating Functional Dyspepsia?

Phase 1
Conditions
Functional Dyspepsia
Interventions
Procedure: Visceral Manipulation
Registration Number
NCT01021475
Lead Sponsor
International College of Osteopathic Medicine
Brief Summary

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.

Detailed 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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Usual drug FD therapyPPIs and/or Domperidone-
Usual drug FD therapy + Visceral ManipulationVisceral Manipulation-
Primary Outcome Measures
NameTimeMethod
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burningbaseline, 1, 4 and 8 weeks after therapy start
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ambulatori Comunali di Cavenago Brianza

🇮🇹

Cavenago Di Brianza, Milano, Italy

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