Effect of Osteopathic Manual Techniques on the Diaphragm Muscle and Its Repercussions

April 1, 2024 updated by: Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto

Effect of Osteopathic Manual Techniques on the Diaphragm Muscle and Its Repercussions in Healthy Young Adults

Determining the effects of an intervention plan on the diaphragm related to the center of gravity and range of motion in the lumbar spine (static and dynamic) in healthy individuals is an area that lacks evidence and proper studies. Has such, the investigators consider this a interesting topic to study, therefore it is intended to improve the knowledge on this area.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All diaphragmatic activity is controlled by metabolic mechanisms and emotional states which may cause restrictions that might be related to disorders in the lower back.

The diaphragm and the lumbar segment of the spine are connected through the diaphgramathic pillars that connect the central tendon and the vertebrae of L2 (left side) and L3/L4 (right side). Consequently, the contraction of the pillars may be related to the fixation of the lumbar spine.

Proper function of the diaphragm is related to better parameters of static balance. It is also possible to conclude that a change in the proper function of the diaphragm is associated with changes in the center of gravity in healthy individuals.

This theme lacks scientific evidence, since no studies were found that focus on the analysis of diaphragmatic treatment only. In this way, the investigators intend to collaborate to increase knowledge in this area, determining the effects of the intervention plan on the diaphragm in relation to the range of motion and center of gravity in the lumbar spine (static and dynamic) in healthy individuals.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • Portugal
      • Porto, Portugal, 4200-072
        • Escola Superior de Saúde do Politecnico do Porto
        • Contact:

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages between 18 and 30 years old;
  • Both genders;

Exclusion Criteria:

  • Treatments with manual therapy in the last three months or more than three times in the previous year;
  • Lumbar spine pathology (infection, spinal fracture or more severe neurological impairment, such as cauda equina syndrome) and respiratory pathologies;
  • Psychiatric illness;
  • Recent history of trauma;
  • History of cancer;
  • Systemic inflammatory conditions;
  • Recent history of spinal surgery;
  • Abdominal pain at the time of the intervention;
  • Body mass index (BMI) equal to or greater than 31kg / m2, due to the difficulty in accessing the diaphragm;
  • All of those that acquired a higher knowledge within the area of manual therapy, which may compromise its validation.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Protocol in Diaphragm

In each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique.

Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed.

Next, the researcher will perform the intervention protocol in Diaphragm. Then, all the measurements described before, will be repeated by the assessor right after the technique.
Other: Intervention Protocol in Diaphragm

The protocol consists of three techniques. The two first techniques will be applied for 10 respiratory cycles.

Muscle Stretching Technique:

the researcher will perform a cephalic traction on the inferior costal border with the ulnar border during the inspiratory phase.

Phrenic-center inhibition technique:

the researcher, with a hand on the sternum to caudal and other hand on the umbilical region to cranial, will approach his hands on the horizontal plane, when the volunteer exales.

Functional diaphragm technique:

the researcher will perform a vertical pressure on the diaphragm for 5 minutes and will search for the facilitated parameters and maintain them until the release of all the periarticular elements.
Sham Comparator: Sham Technique

In each volunteer, after a brief questionnaire, it will be measured the center of gravity and the range of movement of the lumbar spine before the technique.

Each volunteer will stay in supine position with arms along their body, in which their legs may be either extended or flexed.

Next, the researcher will perform the Sham technique. Then, all the measurements described before, will be repeated by the assessor right after the technique.
Other: Sham technique
In the sham group a manual contact without any therapeutic intention will be performed, in a distant region of the diaphragm (for example on the trapezius muscle). This contact will be maintained during the same amount of time as for the treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline of Center of gravity immediately after the intervention
Time Frame: Immediately after the intervention

To obtain the center of gravity measurements, it will be used the system Qualisys Track Manager. First, it will be placed in the subject spheric markers on the spinous processes of T12, L3 and S2 and both anterior and posterior superior iliac spines.

The cameras will be arranged to cover the area to the test, which it will be performed in a hard surface with the help of reflector-markers that will evaluate the movements.

The data will be collected twice, with the eyes open and closed. They'll be standing in the platform for 90 seconds each time and the data will be collected at the 30, 60 and 90 seconds.

The software is going to be used to convert the data in coordinates in the x, y and z axis, which it will allow to analyse the tridimensional kinematics of the lumbar spine Through the intrinsical board of Qualysis Track Manager it will be evaluated the relation of the center of pressure with the vertical projection of the center of mass through the distance between both.
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Range of Movement of the lumbar spine immediately after the intervention
Time Frame: Immediately after the intervention

To obtain the center of gravity measurements, it will be used the system Qualisys Track Manager. First, it will be placed in the subject spheric markers on the spinous processes of T12, L3 and S2 and both anterior and posterior superior iliac spines.

The cameras will be arranged to cover the area to the test, which it will be performed in a hard surface with the help of reflector-markers that will evaluate the movements.

The data will be collected by asking the volunteer to perform certain movements such as anterior and lateral flexion.

The software is going to be used to convert the data in coordinates in the x, y and z axis, which it will allow to analyse the tridimensional kinematics of the lumbar spine Through the intrinsical board of Qualysis Track Manager it will be evaluated the relation of the center of pressure with the vertical projection of the center of mass through the distance between both.
Immediately after the intervention

Collaborators and Investigators

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

Sponsor

Escola Superior de Tecnologia da Saúde do Porto

Investigators

  • Principal Investigator: Natália MO Campelo, PhD, Escola Superior de Saúde do Politecnico do Porto

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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OST1- 001

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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