Does Visceral Manipulation Works in Treating Functional Dyspepsia?

November 27, 2009 updated by: International College of Osteopathic Medicine

Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milano
      • Cavenago Di Brianza, Milano, Italy, 20040
        • Recruiting
        • Ambulatori Comunali di Cavenago Brianza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usual drug FD therapy + Visceral Manipulation
Procedure: Visceral Manipulation
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy.
Active Comparator: Usual drug FD therapy
Drug: PPIs and/or Domperidone
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning
Time Frame: baseline, 1, 4 and 8 weeks after therapy start
baseline, 1, 4 and 8 weeks after therapy start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International College of Osteopathic Medicine

Investigators

  • Principal Investigator: Rossi Massimo, DO B.Sc (student), International College of Osteopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2009

Last Update Submitted That Met QC Criteria

November 27, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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