Pubic and Abdominal PathologyPhase 2ShortystrapNCT02882399
Shortystrap Effectiveness in the Treatment of the Pathology Pubic and Abdominal Pathology in Athletes
A Phase 2 study testing Shortystrap in people with Pubic and Abdominal Pathology, run by Rennes University Hospital at 1 site in France.
Trial summary
The pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Pubic and Abdominal Pathology
- What is being tested?
- Shortystrap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2013to 6 Nov 2015
- Phase
- Phase 2
- 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 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Sports practicing physical activity at least 3 hours per week
- Practicing a team sport with a major part of running (football, rugby, ...)
- Presenting a pubic and abdominal pathology for at least 4 weeks
- In primary consultation
- Age from 18 to 40 years
- Informed consent signed
Who cannot join
- Professional athlete
- Cyclist
- Having already received usual medical treatment (anti-inflammatory treatment and rest)
- Introducing another disease requiring treatment with NSAIDs
- Allergy neoprene
- Contraindications to performing MRI (claustrophobia, any metal device, pacemaker, etc.)
- Simultaneous participation in another biomedical research
- Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
The pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports.
- Conditions
- Pubic and Abdominal Pathology
- Being tested
- Shortystrap
- Keywords
- athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShortystrapOther
| Study group | Role | What they receive |
|---|---|---|
| Shortystrap | Experimental | Not described Receives: Other: Shortystrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain using a scale Feretti
scale Feretti
Measured: Day 15
Secondary outcomes (1)
Evaluation of pain using a visual analog scale
visual analog scale
Measured: Day 15, Day 30 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start12 Apr 2013
- Primary completion20 Aug 2015
- Study completion6 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pubic and Abdominal PathologyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierrick GUILLEMOT, Md, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882399
- Sponsor's protocol ID
- 2012-A01172-41
- Other IDs
- 35RC12_8971
- Acronym
- Shortystrap
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortystrap Effectiveness in the Treatment of the Pathology Pubic and Abdominal Pathology in Athletes
- ClinicalTrials.gov ID
- NCT02882399
- Acronym / sponsor ID
- Shortystrap / 2012-A01172-41
- Conditions
- Pubic and Abdominal Pathology
- Keywords
- athletes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2013 (actual)
- Primary completion
- 20 Aug 2015 (actual)
- Study completion
- 6 Nov 2015 (actual)
- First posted
- 29 Aug 2016 (estimated)
- 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 pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shortystrap | Experimental | Other: Shortystrap |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Sports practicing physical activity at least 3 hours per week
- Practicing a team sport with a major part of running (football, rugby, ...)
- Presenting a pubic and abdominal pathology for at least 4 weeks
- In primary consultation
Key exclusion criteria (8 listed)
- Professional athlete
- Cyclist
- Having already received usual medical treatment (anti-inflammatory treatment and rest)
- Introducing another disease requiring treatment with NSAIDs
- Allergy neoprene
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 |
|---|---|---|
| Shortystrap | Other | Shortystrap |
Primary outcome
Evaluation of pain using a scale Feretti
Time frame: Day 15
scale Feretti
1 secondary outcome
Evaluation of pain using a visual analog scale
Time frame: Day 15, Day 30 and Day 60
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 25 Sep 2019.
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.
Pierrick GUILLEMOT, Md study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shortystrap in people with Pubic and Abdominal Pathology, run by Rennes University Hospital 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 7 inclusion and 8 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 25 Sep 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of pain using a scale Feretti (time frame: Day 15). 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 25 Sep 2019.