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

Studies

Study First Submitted Date 2020-05-19
Study First Posted Date 2020-05-22
Last Update Posted Date 2023-03-01
Start Month Year January 2024
Primary Completion Month Year September 2024
Verification Month Year February 2023
Verification Date 2023-02-28
Last Update Posted Date 2023-03-01

Detailed Descriptions

Sequence: 20564564
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.

Facilities

Sequence: 198540344
Name Escola Superior de Saúde do Politécnico do Porto
City Porto
Zip 4200-072
Country Portugal

Facility Contacts

Sequence: 27934027
Facility Id 198540344
Contact Type primary
Name Natália MO Campelo, PhD
Email ncampelo.estsp.ipp@gmail.com
Phone +351938674365

Conditions

Sequence: 51766739
Name Healthy
Downcase Name healthy

Id Information

Sequence: 39836048
Id Source org_study_id
Id Value OST1- 001

Countries

Sequence: 42234339
Name Portugal
Removed False

Design Groups

Sequence: 55186310 Sequence: 55186311
Group Type Experimental Group Type Sham Comparator
Title Intervention Protocol in Diaphragm Title Sham Technique
Description 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. Description 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.

Interventions

Sequence: 52088299 Sequence: 52088300
Intervention Type Other Intervention Type Other
Name Intervention Protocol in Diaphragm Name Sham technique
Description 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. Description 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.

Keywords

Sequence: 79204397 Sequence: 79204398 Sequence: 79204399 Sequence: 79204400 Sequence: 79204401
Name Osteopathy Name Diaphragm Name Center of Pressure Name Range of Motion Name Thoracolumbar
Downcase Name osteopathy Downcase Name diaphragm Downcase Name center of pressure Downcase Name range of motion Downcase Name thoracolumbar

Design Outcomes

Sequence: 176072478 Sequence: 176072479
Outcome Type primary Outcome Type secondary
Measure Change from Baseline of Center of gravity immediately after the intervention Measure Change from Baseline in Range of Movement of the lumbar spine immediately after the intervention
Time Frame Immediately after the intervention Time Frame Immediately after the intervention
Description 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. Description 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.

Sponsors

Sequence: 47942748
Agency Class OTHER
Lead Or Collaborator lead
Name Escola Superior de Tecnologia da Saúde do Porto

Overall Officials

Sequence: 29047750
Role Principal Investigator
Name Natália MO Campelo, PhD
Affiliation Escola Superior de Saúde do Politécnico do Porto

Central Contacts

Sequence: 11927432
Contact Type primary
Name Natália MO Campelo, PhD
Phone +351 938674365
Email ncampelo.estsp.ipp@gmail.com
Role Contact

Design Group Interventions

Sequence: 67657818 Sequence: 67657819
Design Group Id 55186310 Design Group Id 55186311
Intervention Id 52088299 Intervention Id 52088300

Eligibilities

Sequence: 30528562
Gender All
Minimum Age 18 Years
Maximum Age 30 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria 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.
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254099876
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 30
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30277333
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking Double
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.
Subject Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28656730
Responsible Party Type Principal Investigator
Name Natália Maria Oliveira Campelo
Title Professor
Affiliation Escola Superior de Tecnologia da Saúde do Porto

Study References

Sequence: 51659935 Sequence: 51659936 Sequence: 51659937 Sequence: 51659938 Sequence: 51659939 Sequence: 51659940 Sequence: 51659941 Sequence: 51659942 Sequence: 51659943 Sequence: 51659944 Sequence: 51659945 Sequence: 51659946 Sequence: 51659947 Sequence: 51659948 Sequence: 51659949 Sequence: 51659950 Sequence: 51659951 Sequence: 51659952
Pmid 23759340 Pmid 7987418 Pmid 22411950 Pmid 23730805 Pmid 16550447 Pmid 29787734 Pmid 19502217 Pmid 21593658 Pmid 12592542 Pmid 29765877 Pmid 30637313 Pmid 11934426 Pmid 17611029 Pmid 16624560
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
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