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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02882399
Other study ID # 2012-A01172-41
Secondary ID 35RC12_8971
Status Completed
Phase Phase 2
First received
Last updated
Start date April 12, 2013
Est. completion date November 6, 2015

Study information

Verified date August 2016
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date November 6, 2015
Est. primary completion date August 20, 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Shortystrap


Locations

Country Name City State
France CHU Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of pain using a scale Feretti scale Feretti Day 15
Secondary Evaluation of pain using a visual analog scale visual analog scale Day 15, Day 30 and Day 60