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Effect of Osteopathic Manipulations on Portal Venous Flow

NCT03516344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-10-10

No results posted yet for this study

Summary

Since osteopathy it is considered that the alterations in the mobility of the different structures of the organism could cause a decrease in the blood circulation of the tissue causing a functional disorder and, with time, the appearance of a disease.

In visceral osteopathy, the treatment of liver dysfunctions it is important due to their interrelation with the functioning of the rest of the abdominal and pelvic viscera and, especially, through the hepatic portal system. However, there are few studies showing whether a manual therapeutic intervention can affect the mobility, function or vascularization of a viscera.

Ultrasonography is an appropriate tool for validating some of these intervention procedures given their safety, repeatability, autonomy and the low cost of the procedures and technical equipment which, in a non-invasive manner, will allow the effects of the different therapeutic interventions to be verified.

Hypothesis:

1. Vertebral manipulations and pumping of the liver improve the flow of the portal vein in front of the diaphragmatic breathing and the contraction of the psoas iliac muscle.
2. The accuracy of ultrasound to assess venous flow may be useful as an outcome measure.

Objectives: To describe the immediate changes of different manipulative interventions on portal vein flow in healthy women and to obtain baseline measurements for future research.

Sample description: Pilot randomized controlled clinical trial with a sample of 50 healthy adult women recruited intentionally sampled that will be pseudo-randomly forcing equality of groups: control, chest manipulation, liver manipulation, abdominal breathing and iliac psoas muscle contraction.

The minimum size required has been calculated using the program G\*Power 3.1.3 for Windows (University Kiel, Germany, 2008) based on an effect size of 0.5, type I error of 5%,type II error of 10% and an effect size of f=0.45.

Conditions

  • Breathing Exercises
  • Manipulation, Osteopathic
  • Physical Therapy
  • Ultrasonography
  • Portal Vein

Interventions

PROCEDURE

Liver pumping and Spinal manipulation

Interventions are described in group descriptions

Sponsors & Collaborators

  • Universidad Antonio de Nebrija

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516344 on ClinicalTrials.gov