Effect of Osteopathic Manipulations on Portal Venous Flow (ECOPORTA)

October 9, 2018 updated by: José Ríos-Díaz, Universidad Antonio de Nebrija

Effect of Osteopathic Manipulations on Portal Venous Flow: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The non-invasive intervention procedure in each of the groups is as follows:

  1. Control group (CG): Subjects will remain at rest in supine position for one minute.
  2. Thoracic manipulation group (GMT): A semi-direct vertebral manipulation will be performed, type Dog Technique in extension, above level D8.
  3. Liver manipulation group (HMG): A supine hepatic pumping technique will be performed, performing simultaneous compression in the right hypochondrium and epigastrium, in the opposite direction, during the inspiratory phase, stopping during the expiratory phase and repeating the maneuver for five respiratory cycles.
  4. Abdominal breathing group (GRA): Subjects will be asked to perform five cycles of diaphragmatic breathing in the supine position.
  5. Psoas exercise group (GPS): In the supine position with a high density foam cushion under the feet of the subject, it will be asked to make a push in the caudal direction, against the cushion, alternating between both feet with the knees stretched, for one minute.

After informed consent and recording of personal data, participants will be placed in a constant and regulated temperature room where they will be placed in supine position for 5 minutes for cardiocirculatory normalization, at least 2 hours after the last meal. The room where the explorations will be carried out is conditioned to keep the ambient temperature constant.

The study will be carried out with independent recruitment and triple blinding: the patient will not know the intervention group, the sonographer will not know the technique applied to the patients, the researcher responsible for recording the flows and diameters and the temperature will also be masked and the data analyst will be masked during the statistical analysis process.

For statistical analysis, a descriptive analysis using means and standard deviations will be performed, as well as ranges and quartiles for quantitative measurements. Qualitative variables shall be summarised by counts and frequencies. The assumption of normality (Shapiro-Wilks test) and equality of variances (Levene's test) prior to the analysis of variance (ANOVA) will be checked for repeated measurements in which the intra-unit factors (three time measurements) will be the dependent variables (velocity, diameter and temperature) and the inter-subject factor, the study group. If it is not possible to assume the application assumptions, the corresponding non-parametric tests will be chosen. Pair comparisons were made with the Dunn-Bonferroni correction for type I erro and the age and BMI variables were entered into the model as covariates to estimate their possible effect on the dependent variables. The percentages of change from the baseline values in the intra-group comparison and from the control group in the intergroup comparison shall be calculated. The effect size will be estimated with the Hedges g statistic.

The significance level will be set to p<0.05 and calculations will be performed with SPSS 19.0

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28036
        • José Ríos-Díaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women
  • No history of abdominal surgery or liver disease

Exclusion Criteria:

  • Fear or apprehension of techniques

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Subjects will remain at rest in supine position for one minute.
Experimental: Iliac psoas muscle
In supine position with a high-density foam cushion under the subject's feet, they will be asked to make a push in the caudal direction, against the cushion, alternating between both feet with their knees stretched out, for one minute
Procedure: Liver pumping and Spinal manipulation
Interventions are described in group descriptions
Other Names:
  • Vertebral manipulation
  • Soft tissues mobilization
Experimental: Diaphragmatic Breathing
Subjects perform five cycles of diaphragmatic breathing in the supine position.
Procedure: Liver pumping and Spinal manipulation
Interventions are described in group descriptions
Other Names:
  • Vertebral manipulation
  • Soft tissues mobilization
Experimental: Liver pumping
A technique of hepatic supine pumping is performed by simultaneous compression in the right hypochondrium and epigastrium, in the opposite direction, during the inspiratory phase, stopping during the expiratory phase and repeating the maneuver for five respiratory cycles.
Procedure: Liver pumping and Spinal manipulation
Interventions are described in group descriptions
Other Names:
  • Vertebral manipulation
  • Soft tissues mobilization
Experimental: Spinal manipulation
A semi-direct vertebral manipulation, type Dog Technique in extension, will be performed on level D8
Procedure: Liver pumping and Spinal manipulation
Interventions are described in group descriptions
Other Names:
  • Vertebral manipulation
  • Soft tissues mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow velocity of the portal vein
Time Frame: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

In cm/s, FV is obtained from ultrasound scans (General Electric LogiqE ultrasound scanner model with the 4C-RS convex probe with a working frequency of 2-5 MHz.).

All image optimization parameters remained constant for all patients and scans. The records will be made by a researcher with 15 years of ultrasound experience.
Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
Diameter of the portal vein
Time Frame: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

In mm, DIA is obtained from ultrasound scans (General Electric LogiqE ultrasound scanner model with the 4C-RS convex probe with a working frequency of 2-5 MHz.).

All image optimization parameters remained constant for all patients and scans. The records will be made by a researcher with 15 years of ultrasound experience.
Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature of D7-D8 dermatome
Time Frame: Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
The temperature of the dermatome D7-D8, in relation metameric to the liver, is recorded at the xiphoid process level with an infrared thermometer (ºC)
Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Antonio de Nebrija

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eco_Porta

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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