NCT03516344

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:

  1. 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. 2.The accuracy of ultrasound to assess venous flow may be useful as an outcome measure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

March 23, 2018

Last Update Submit

October 9, 2018

Conditions

Breathing ExercisesManipulation, OsteopathicPhysical TherapyUltrasonographyPortal Vein

Keywords

Breathing ExercisesManipulation, OsteopathicQuantitative UltrasonographyTherapy, Soft TissuePortal VeinVenous flow

Outcome Measures

Primary Outcomes (2)

  • 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.

    Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

  • 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.

    Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

Secondary Outcomes (1)

  • Temperature of D7-D8 dermatome

    Pre-intervention, immediately post-intervention and 5-minutes-post-intervention

Study Arms (5)

Control

NO INTERVENTION

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

Iliac psoas muscle

EXPERIMENTAL

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

Diaphragmatic Breathing

EXPERIMENTAL

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

Procedure: Liver pumping and Spinal manipulation

Liver pumping

EXPERIMENTAL

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

Spinal manipulation

EXPERIMENTAL

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

Procedure: Liver pumping and Spinal manipulation

Interventions

Liver pumping and Spinal manipulationPROCEDURE

Interventions are described in group descriptions

Also known as: Vertebral manipulation, Soft tissues mobilization
Diaphragmatic BreathingIliac psoas muscleLiver pumpingSpinal manipulation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Fear or apprehension of techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Ríos-Diaz

Madrid, 28036, Spain

Location

Related Publications (10)

  • Allan PL, Ph.D WNM, Pozniak MA, Dubbins PA. Ecografía doppler clínica. Elsevier España; 2008.

    BACKGROUND

  • Allan PLP, Baxter GM, Weston M. Clinical Ultrasound. 3rd ed. Philadelphia: Churchill Livingstone Elsevier, 2011

    BACKGROUND

  • Baert AL, Brady LW, Heilmann HP, Molls M, Sartor K. Duplex and color doppler imaging of the venous system. Springer; 2014.

    BACKGROUND

  • Harris W, Wagnon RJ. The effects of chiropractic adjustments on distal skin temperature. J Manipulative Physiol Ther. 1987 Apr;10(2):57-60.

    PMID: 3585197BACKGROUND

  • Hebgen E. Osteopatía Visceral. Fundamentos y técnicas. 2ª edición ed. Madrid: McGraw-Hill. Interamericana; 2005

    BACKGROUND

  • Korr IM. Bases fisiologicas de la osteopatía. 1ª ed.: Mandala; 2004

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Ricard F. Tratado de osteopatía visceral y medicina interna. Tomo 2: Sistema digestivo. 1ª edición ed. Madrid: Editorial Médica Panamericana; 2008

    BACKGROUND

  • 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.

    PMID: 19646369BACKGROUND

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2018

First Posted

May 4, 2018

Study Start

August 1, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

ES(1)