Shoulder InjuryNCT03405844
A Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers
An observational study of Shoulder Injury, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points the injury risk, because an alteration in biomechanics can turn lead to clinical findings of impingement and labral pathology. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injury
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2017to 15 Sep 2017
- Phase
- Observational
- 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Swimmers from the winter national trials who competed at state, national or international level, performed at least five swim sessions per week and intended to continue this training level during the following 24 months were eligible to participate in this study.
Who may be able to join
- elite swimmers
Who cannot join
- shoulder surgery
- dislocation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers After Competition: A Quasi-experimental Clinical Trial
Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points the injury risk, because an alteration in biomechanics can turn lead to clinical findings of impingement and labral pathology. Posterior deltoid is a main muscle for propulsion in swimming stroke. To our knowledge, it isn't known how a posterior deltoid static passive stretch could reduce glenohumeral rotation restriction after swimming competition.
- Conditions
- Shoulder Injury
- Keywords
- Shoulder, glenohumeral, stretching
- Medical subject headings
- Shoulder Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of glenohumeral rotation degrees
Internal and external rotation range of movement
Measured: Basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start15 Sep 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
- Investigators
- JORGE H VILLAFAÑE, PhD, Principal investigator, IRCCS Don Gnocchi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405844
- Sponsor's protocol ID
- SETRADE
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers After Competition: A Quasi-experimental Clinical Trial
- ClinicalTrials.gov ID
- NCT03405844
- Acronym / sponsor ID
- SETRADE
- Conditions
- Shoulder Injury
- Keywords
- Shoulder, glenohumeral, stretching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 23 Jan 2018 (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.
Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points the injury risk, because an alteration in biomechanics can turn lead to clinical findings of impingement and labral pathology. Posterior deltoid is a main muscle for propulsion in swimming stroke. To our knowledge, it isn't known how a posterior deltoid static passive stretch could reduce glenohumeral rotation restriction after swimming competition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Swimmers from the winter national trials who competed at state, national or international level, performed at least five swim sessions per week and intended to continue this training level during the following 24 months were eligible to participate in this study.
Key inclusion criteria (1 listed)
- elite swimmers
Key exclusion criteria (2 listed)
- shoulder surgery
- dislocation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of glenohumeral rotation degrees
Time frame: Basline
Internal and external rotation range of movement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: No
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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.
JORGE H VILLAFAÑE, PhD principal investigator
IRCCS Don Gnocchi Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injury, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 23 Jan 2018. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of glenohumeral rotation degrees (time frame: Basline). 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 23 Jan 2018.