NCT03516344: ECOPORTA

Effect of Osteopathic Manipulations on Portal Venous Flow

Completed NA Last updated 10 October 2018

What this trial tests

NA trial testing Liver pumping and Spinal manipulation in Breathing Exercises in 50 participants. Completed in 30 September 2018.

Timeline

1 August 2018

Primary endpoint
30 September 2018

30 September 2018

Quick facts

Lead sponsor	Universidad Antonio de Nebrija
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	1 August 2018
Primary completion	30 September 2018
Estimated completion	30 September 2018
Sites	1 location across Spain

Drugs / interventions tested

• Liver pumping and Spinal manipulation

Conditions studied

• Breathing Exercises — all drugs for Breathing Exercises →
• Manipulation, Osteopathic — all drugs for Manipulation, Osteopathic →
• Physical Therapy — all drugs for Physical Therapy →
• Ultrasonography — all drugs for Ultrasonography →

Sponsor

Universidad Antonio de Nebrija

Who can join

Adults 18 to 40, female only, with Breathing Exercises or Manipulation, Osteopathic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.