Osteopathic Intervention in Professional Handball Players (ECHODIAPOST)

January 12, 2024 updated by: University Hospital, Toulouse

Ultrasound Evaluation of Diaphragmatic Contractility After Manual Osteopathic Intervention in Professional Handball Players: a Pilot Study

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).

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

      • Créteil, France, 94046
        • Maison du Handball

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy male and female International players who are part of the French Handball team

Exclusion Criteria:

  • history of thoracic or diaphragmatic surgery

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in the fraction of diaphragm thickening (right and left) measured on ultrasound before and after the procedure
Time Frame: Day 1
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
expiratory diaphragmatic thickness
Time Frame: Day 1
expiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
Day 1
Variation of the Forced Vital Capacity (FVC) measured in spirometry before and after the intervention
Time Frame: Day 1
The subject performs spirometry while standing with a Spirobank spirometer. 3 successive measurements keeping only the highest value.
Day 1
Postural analysis
Time Frame: Day 2
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
Day 2
Inspiratory diaphragmatic thickness
Time Frame: day 1
Inspiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
day 1
diaphragmatic contraction velocity
Time Frame: day 1
Diaphragmatic contraction velocity is expressed in % will be measured by echography after manual abdominal osteopathic intervention
day 1
diaphragmatic amplitude
Time Frame: day 1
Diaphragmatic amplitude is expressed in mm and will be measured by echography after manual abdominal osteopathic intervention
day 1

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Elise NOEL-SAVINA, MD, CHU Toulouse

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 (Actual)

July 30, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0146

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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