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Osteopathic Intervention in Professional Handball Players (ECHODIAPOST)

Primary Purpose

Osteopathia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
manual osteopathic intervention
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteopathia focused on measuring diaphragm, ultrasound, contractibility, osteopathic intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy male and female International players who are part of the French Handball team Exclusion Criteria: history of thoracic or diaphragmatic surgery

Sites / Locations

  • Maison du HandballRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental

Arm Description

The intervention evaluated is a technique of prolonged abdominal manual pressure centered on the zone of restriction of mobility called "trigger point" with diaphragmatic aim.

Outcomes

Primary Outcome Measures

Variation in the fraction of diaphragm thickening (right and left) measured on ultrasound before and after the procedure
The subject undergoes the ultrasound which will investigate the contractility of the diaphragm muscle. Two expert sonographers from G-ECHO will perform the ultrasound on each of the athletes, and note 3 successive measurements to check the stability of the results.

Secondary Outcome Measures

expiratory diaphragmatic thickness
expiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
Variation of the Forced Vital Capacity (FVC) measured in spirometry before and after the intervention
The subject performs spirometry while standing with a Spirobank spirometer. 3 successive measurements keeping only the highest value.
Postural analysis
postural analysis will be perform using Cyber-Sabot type platform. the measurements will be done at day 1 before manual abdominal osteopathic intervention and at day 2
Inspiratory diaphragmatic thickness
Inspiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
diaphragmatic contraction velocity
Diaphragmatic contraction velocity is expressed in % will be measured by echography after manual abdominal osteopathic intervention
diaphragmatic amplitude
Diaphragmatic amplitude is expressed in mm and will be measured by echography after manual abdominal osteopathic intervention

Full Information

First Posted
June 23, 2023
Last Updated
October 20, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05942690
Brief Title
Osteopathic Intervention in Professional Handball Players
Acronym
ECHODIAPOST
Official Title
Ultrasound Evaluation of Diaphragmatic Contractility After Manual Osteopathic Intervention in Professional Handball Players: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim is to study the effectiveness of a common osteopathic intervention in professional handball players on diaphragmatic contractility and its correlations with posture. This study has never been done in healthy subjects. It is a scientific process of objectification of an osteopathic technique commonly performed in this population. The main objective is to assess diaphragmatic contractibility using ultrasound after abdominal osteopathic intervention (OMT).
Detailed Description
The context is that of optimizing the performance of professional handball players. The aim is to study the effectiveness of a common osteopathic intervention in professional handball players on diaphragmatic contractility and its correlations with posture. This study has never been done in healthy subjects. It is a scientific process of objectification of an osteopathic technique commonly performed in this population. The main objective is to assess diaphragmatic contractibility after abdominal osteopathic intervention (OMT). The secondary objective is to evaluate the impact of this manual intervention in professional handball players on: other diaphragmatic ultrasound data on spirometry postural control Prospective pilot non-interventional controlled monocentric study opened in healthy male and female International players who are part of the French Handball team. Approach to objectification of current practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopathia
Keywords
diaphragm, ultrasound, contractibility, osteopathic intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
The intervention evaluated is a technique of prolonged abdominal manual pressure centered on the zone of restriction of mobility called "trigger point" with diaphragmatic aim.
Intervention Type
Procedure
Intervention Name(s)
manual osteopathic intervention
Intervention Description
The subject sits on the examination table for the manual osteopathic intervention. The expert osteopath, having no report from the sonographers, will manually test breathing diaphragmatic and will bring osteopathic manual treatment to the area of mobility restriction
Primary Outcome Measure Information:
Title
Variation in the fraction of diaphragm thickening (right and left) measured on ultrasound before and after the procedure
Description
The subject undergoes the ultrasound which will investigate the contractility of the diaphragm muscle. Two expert sonographers from G-ECHO will perform the ultrasound on each of the athletes, and note 3 successive measurements to check the stability of the results.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
expiratory diaphragmatic thickness
Description
expiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
Time Frame
Day 1
Title
Variation of the Forced Vital Capacity (FVC) measured in spirometry before and after the intervention
Description
The subject performs spirometry while standing with a Spirobank spirometer. 3 successive measurements keeping only the highest value.
Time Frame
Day 1
Title
Postural analysis
Description
postural analysis will be perform using Cyber-Sabot type platform. the measurements will be done at day 1 before manual abdominal osteopathic intervention and at day 2
Time Frame
Day 2
Title
Inspiratory diaphragmatic thickness
Description
Inspiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
Time Frame
day 1
Title
diaphragmatic contraction velocity
Description
Diaphragmatic contraction velocity is expressed in % will be measured by echography after manual abdominal osteopathic intervention
Time Frame
day 1
Title
diaphragmatic amplitude
Description
Diaphragmatic amplitude is expressed in mm and will be measured by echography after manual abdominal osteopathic intervention
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy male and female International players who are part of the French Handball team Exclusion Criteria: history of thoracic or diaphragmatic surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise NOEL-SAVINA, MD
Phone
05 67 77 17 46
Ext
+33
Email
noel-savina.e@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Siham MALLAH
Email
mallah.s@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise NOEL-SAVINA, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maison du Handball
City
Créteil
ZIP/Postal Code
94046
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise NOEL-SAVINA, Dr
Phone
0567771746
Ext
+33
Email
noel-savina.e@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Gilles MANGIAPAN, Dr

12. IPD Sharing Statement

Learn more about this trial

Osteopathic Intervention in Professional Handball Players

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