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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04399993
• Other study ID #: OST1- 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Escola Superior de Tecnologia da Saúde do Porto
• Contact: Natália MO Campelo, PhD
• Phone: +351 938674365
• Email: ncampelo.estsp.ipp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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 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.

Locations

Country	Name	City	State
Portugal	Escola Superior de Saúde do Politécnico do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of Center of gravity 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	Change from Baseline in Range of Movement of the lumbar spine 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