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

Sponsor

Escola Superior de Tecnologia da Saúde do Porto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04399993

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Intervention Protocol in Diaphragm Other: Sham technique	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The volunteers will be allocated randomly using a website called radom.org, which ensures that neither neither the volunteer nor the assessor will know the final allocation.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline of Center of gravity immediately after the intervention [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.

Secondary Outcome Measures

Change from Baseline in Range of Movement of the lumbar spine immediately after the intervention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Escola Superior de Saúde do Politécnico do Porto	Porto		Portugal	4200-072

Sponsors and Collaborators

Escola Superior de Tecnologia da Saúde do Porto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto

ClinicalTrials.gov Identifier:

NCT04399993

Other Study ID Numbers:

OST1- 001

First Posted:

May 22, 2020

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto

Study Results

No Results Posted as of Mar 24, 2022