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Does Visceral Manipulation Works in Treating Functional Dyspepsia?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by International College of Osteopathic Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
International College of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT01021475
First received: November 27, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study

Resource links provided by NLM:


Further study details as provided by International College of Osteopathic Medicine:

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

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Massimo Rossi DO BSc (student), ICOM
ClinicalTrials.gov Identifier: NCT01021475     History of Changes
Other Study ID Numbers: VM-01
Study First Received: November 27, 2009
Last Updated: November 27, 2009
Health Authority: Italy: Ministero della Sanità

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

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

ClinicalTrials.gov processed this record on November 20, 2014