Functional Dyspepsia
Conditions
Keywords
Functional Dyspepsia, Visceral Manipulation
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.
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).
Interventions
PROCEDUREVisceral 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.
DRUGPPIs and/or Domperidone
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks
Sponsors
International College of Osteopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning | baseline, 1, 4 and 8 weeks after therapy start |
Countries
Italy
Contacts
Primary ContactMassimo Rossi, DO B.Sc (Student)
Outcome results
None listed