ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Visceral Manipulation Works in Treating Functional Dyspepsia?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01021475
Recruitment Status : Unknown
Verified November 2009 by International College of Osteopathic Medicine.
Recruitment status was:  Recruiting
First Posted : November 30, 2009
Last Update Posted : November 30, 2009
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Functional Dyspepsia Procedure: Visceral Manipulation Drug: PPIs and/or Domperidone Phase 1

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study
Study Start Date : November 2009
Estimated Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
Drug Information available for: Domperidone
U.S. FDA Resources

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



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021475


Contacts
Contact: Massimo Rossi, DO B.Sc (Student) 00393929517349 massimo@rossimassimo.com

Locations
Italy
Ambulatori Comunali di Cavenago Brianza Recruiting
Cavenago Di Brianza, Milano, Italy, 20040
Contact: Massimo Rossi, DO B.Sc (student)    0039 3929517349    massimo@rossimassimo.com   
Sponsors and Collaborators
International College of Osteopathic Medicine
Investigators
Principal Investigator: Rossi Massimo, DO B.Sc (student) International College of Osteopathic Medicine

Responsible Party: Massimo Rossi DO BSc (student), ICOM
ClinicalTrials.gov Identifier: NCT01021475     History of Changes
Other Study ID Numbers: VM-01
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: November 30, 2009
Last Verified: November 2009

Keywords provided by International College of Osteopathic Medicine:
Functional Dyspepsia, Visceral Manipulation

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action