Does Visceral Manipulation Works in Treating Functional Dyspepsia?

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01021475
• Other study ID #: VM-01
• Status: Recruiting
• Phase: Phase 1
• First received: November 27, 2009
• Last updated: November 27, 2009
• Start date: November 2009

Study information

• Verified date: November 2009
• Source: International College of Osteopathic Medicine
• Contact: Massimo Rossi, DO B.Sc (Student)
• Phone: 00393929517349
• Email: massimo[@]rossimassimo.com
• Is FDA regulated: No
• Health authority: Italy: Ministero della Sanità
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

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.

Drug:
• PPIs and/or Domperidone
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks

Locations

Country	Name	City	State
Italy	Ambulatori Comunali di Cavenago Brianza	Cavenago Di Brianza	Milano

Sponsors (1)

Lead Sponsor	Collaborator
International College of Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning		baseline, 1, 4 and 8 weeks after therapy start	Yes