Does Visceral Manipulation Works in Treating Functional Dyspepsia?

NCT ID: NCT01021475

Last Updated: 2009-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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

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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).

Conditions

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Functional Dyspepsia

Keywords

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Functional Dyspepsia, Visceral Manipulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual drug FD therapy + Visceral Manipulation

Group Type EXPERIMENTAL

Visceral Manipulation

Intervention Type PROCEDURE

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.

Usual drug FD therapy

Group Type ACTIVE_COMPARATOR

PPIs and/or Domperidone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type PROCEDURE

PPIs and/or Domperidone

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International College of Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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ICOM

Principal Investigators

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Rossi Massimo, DO B.Sc (student)

Role: PRINCIPAL_INVESTIGATOR

International College of Osteopathic Medicine

Locations

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Ambulatori Comunali di Cavenago Brianza

Cavenago di Brianza, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Massimo Rossi, DO B.Sc (Student)

Role: CONTACT

Phone: 00393929517349

Email: [email protected]

Facility Contacts

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Massimo Rossi, DO B.Sc (student)

Role: primary

Other Identifiers

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VM-01

Identifier Type: -

Identifier Source: org_study_id