Effect of Osteopathic Manipulations on Portal Venous Flow
Condition: Breathing Exercises; Manipulation, Osteopathic; Physical Therapy; Ultrasonography; Portal Vein
MeSH terms: Respiratory Aspiration
Study type: Interventional

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.
    

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
    

Intervention name(s): Liver pumping and Spinal manipulation
Intervention type(s): Procedure
Intervention description(s): Interventions are described in group descriptions
Other intervention name(s): Vertebral manipulation; Soft tissues mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breathing Exercises; Manipulation, Osteopathic; Quantitative Ultrasonography; Therapy, Soft Tissue; Portal Vein; Venous flow