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Effect of Osteopathic Manipulations on Portal Venous Flow (ECOPORTA)

Primary Purpose

Breathing Exercises, Manipulation, Osteopathic, Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Liver pumping and Spinal manipulation
Sponsored by
Universidad Antonio de Nebrija
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breathing Exercises focused on measuring Breathing Exercises, Manipulation, Osteopathic, Quantitative Ultrasonography, Therapy, Soft Tissue, Portal Vein, Venous flow

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Fear or apprehension of techniques

Sites / Locations

  • José Ríos-Diaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Iliac psoas muscle

Diaphragmatic Breathing

Liver pumping

Spinal manipulation

Arm Description

Subjects will remain at rest in supine position for one minute.

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

Subjects perform five cycles of diaphragmatic breathing in the supine position.

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.

A semi-direct vertebral manipulation, type Dog Technique in extension, will be performed on level D8

Outcomes

Primary Outcome Measures

Flow velocity of the portal vein
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.
Diameter of the portal vein
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.

Secondary Outcome Measures

Temperature of D7-D8 dermatome
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)

Full Information

First Posted
March 23, 2018
Last Updated
October 9, 2018
Sponsor
Universidad Antonio de Nebrija
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1. Study Identification

Unique Protocol Identification Number
NCT03516344
Brief Title
Effect of Osteopathic Manipulations on Portal Venous Flow
Acronym
ECOPORTA
Official Title
Effect of Osteopathic Manipulations on Portal Venous Flow: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Antonio de Nebrija

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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. 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.
Detailed Description
The non-invasive intervention procedure in each of the groups is as follows: Control group (CG): Subjects will remain at rest in supine position for one minute. Thoracic manipulation group (GMT): A semi-direct vertebral manipulation will be performed, type Dog Technique in extension, above level D8. 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. Abdominal breathing group (GRA): Subjects will be asked to perform five cycles of diaphragmatic breathing in the supine position. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing Exercises, Manipulation, Osteopathic, Physical Therapy, Ultrasonography, Portal Vein
Keywords
Breathing Exercises, Manipulation, Osteopathic, Quantitative Ultrasonography, Therapy, Soft Tissue, Portal Vein, Venous flow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will remain at rest in supine position for one minute.
Arm Title
Iliac psoas muscle
Arm Type
Experimental
Arm Description
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
Arm Title
Diaphragmatic Breathing
Arm Type
Experimental
Arm Description
Subjects perform five cycles of diaphragmatic breathing in the supine position.
Arm Title
Liver pumping
Arm Type
Experimental
Arm Description
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.
Arm Title
Spinal manipulation
Arm Type
Experimental
Arm Description
A semi-direct vertebral manipulation, type Dog Technique in extension, will be performed on level D8
Intervention Type
Procedure
Intervention Name(s)
Liver pumping and Spinal manipulation
Other Intervention Name(s)
Vertebral manipulation, Soft tissues mobilization
Intervention Description
Interventions are described in group descriptions
Primary Outcome Measure Information:
Title
Flow velocity of the portal vein
Description
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.
Time Frame
Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
Title
Diameter of the portal vein
Description
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.
Time Frame
Pre-intervention, immediately post-intervention and 5-minutes-post-intervention
Secondary Outcome Measure Information:
Title
Temperature of D7-D8 dermatome
Description
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)
Time Frame
Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy women No history of abdominal surgery or liver disease Exclusion Criteria: Fear or apprehension of techniques
Facility Information:
Facility Name
José Ríos-Diaz
City
Madrid
ZIP/Postal Code
28036
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
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Results Reference
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Citation
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Citation
Baert AL, Brady LW, Heilmann HP, Molls M, Sartor K. Duplex and color doppler imaging of the venous system. Springer; 2014.
Results Reference
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PubMed Identifier
3585197
Citation
Harris W, Wagnon RJ. The effects of chiropractic adjustments on distal skin temperature. J Manipulative Physiol Ther. 1987 Apr;10(2):57-60.
Results Reference
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Citation
Hebgen E. Osteopatía Visceral. Fundamentos y técnicas. 2ª edición ed. Madrid: McGraw-Hill. Interamericana; 2005
Results Reference
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Citation
Korr IM. Bases fisiologicas de la osteopatía. 1ª ed.: Mandala; 2004
Results Reference
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Citation
Martínez-Payá JJ, de-Groot-Ferrando A, Ríos-Díaz J, del-Baño-Aledo ME. Sonoanatomy of the musculoskeletal system. En: Valera F, Minaya F, editores. Advanced Techniques in Musculoskeletal Medicine & Physiotherapy. Edinburgh: Churchill Livingstone; 2016. p.147-70.
Results Reference
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Citation
Resende C, Lessa A, Goldenberg RCS. Ultrasonic Imaging in Liver Disease: From Bench to Bedside. Rijeka, Croatia: INTECH Open Access Publisher; 2011.p.127-56.
Results Reference
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Citation
Ricard F. Tratado de osteopatía visceral y medicina interna. Tomo 2: Sistema digestivo. 1ª edición ed. Madrid: Editorial Médica Panamericana; 2008
Results Reference
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PubMed Identifier
19646369
Citation
Welch A, Boone R. Sympathetic and parasympathetic responses to specific diversified adjustments to chiropractic vertebral subluxations of the cervical and thoracic spine. J Chiropr Med. 2008 Sep;7(3):86-93. doi: 10.1016/j.jcm.2008.04.001.
Results Reference
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Effect of Osteopathic Manipulations on Portal Venous Flow

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