NCT05942690

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).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

1 day

First QC Date

June 23, 2023

Last Update Submit

January 12, 2024

Conditions

Keywords

diaphragmultrasoundcontractibilityosteopathic intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1

Secondary Outcomes (6)

  • expiratory diaphragmatic thickness

    Day 1

  • Variation of the Forced Vital Capacity (FVC) measured in spirometry before and after the intervention

    Day 1

  • Postural analysis

    Day 2

  • Inspiratory diaphragmatic thickness

    day 1

  • diaphragmatic contraction velocity

    day 1

  • +1 more secondary outcomes

Study Arms (1)

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.

Procedure: manual osteopathic intervention

Interventions

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

experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • history of thoracic or diaphragmatic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison du Handball

Créteil, 94046, France

Location

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Elise NOEL-SAVINA, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 12, 2023

Study Start

July 30, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations