OsteopathiaECHODIAPOSTNCT05942690
Osteopathic Intervention in Professional Handball Players
A study testing manual osteopathic intervention in people with Osteopathia, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopathia
- What is being tested?
- manual osteopathic intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male and female International players who are part of the French Handball team
Who cannot join
- history of thoracic or diaphragmatic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Osteopathia
- Being tested
- manual osteopathic intervention
- Keywords
- diaphragm, ultrasound, contractibility, osteopathic intervention
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual osteopathic interventionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: manual osteopathic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (6)
expiratory diaphragmatic thickness
expiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
Measured: Day 1
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.
Measured: Day 1
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
Measured: Day 2
Inspiratory diaphragmatic thickness
Inspiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
Measured: day 1
diaphragmatic contraction velocity
Diaphragmatic contraction velocity is expressed in % will be measured by echography after manual abdominal osteopathic intervention
Measured: day 1
diaphragmatic amplitude
Diaphragmatic amplitude is expressed in mm and will be measured by echography after manual abdominal osteopathic intervention
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start30 Jul 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Why it stopped: no more possibly to include subjects (subject unavailability)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopathiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise NOEL-SAVINA, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942690
- Sponsor's protocol ID
- RC31/23/0146
- Acronym
- ECHODIAPOST
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Diaphragmatic Contractility After Manual Osteopathic Intervention in Professional Handball Players: a Pilot Study
- ClinicalTrials.gov ID
- NCT05942690
- Acronym / sponsor ID
- ECHODIAPOST / RC31/23/0146
- Conditions
- Osteopathia
- Keywords
- diaphragm, ultrasound, contractibility, osteopathic intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more possibly to include subjects (subject unavailability)
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Procedure: manual osteopathic interventionThe intervention evaluated is a technique of prolonged abdominal manual pressure centered on the zone of restriction of mobility called "trigger point" with diaphragmatic aim. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy male and female International players who are part of the French Handball team
Key exclusion criteria (1 listed)
- history of thoracic or diaphragmatic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual osteopathic interventionThe 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 | Procedure or surgery | experimental |
Primary outcome
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.
6 secondary outcomes
expiratory diaphragmatic thickness
Time frame: Day 1
Variation of the Forced Vital Capacity (FVC) measured in spirometry before and after the intervention
Time frame: Day 1
Postural analysis
Time frame: Day 2
Inspiratory diaphragmatic thickness
Time frame: day 1
diaphragmatic contraction velocity
Time frame: day 1
diaphragmatic amplitude
Time frame: day 1
Results and safety
The study was stopped early (reason given: no more possibly to include subjects (subject unavailability)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Related trials for Osteopathia
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruitingObservational study
SLAMF1 Gene Expression in Ankylosing Spondylitis
Ankylosing Spondylitis
RecruitingObservational study
Screening and Natural History of Patients With Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome
McCune-Albright Syndrome
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elise NOEL-SAVINA, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual osteopathic intervention in people with Osteopathia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no more possibly to include subjects (subject unavailability)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in the fraction of diaphragm thickening (right and left) measured on ultrasound before and after the procedure (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.