Shortystrap Effectiveness in the Treatment of the Pathology Pubic and Abdominal Pathology in Athletes (Shortystrap)

September 24, 2019 updated by: Rennes University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France
        • Chu Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Shortystrap
Other: Shortystrap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pain using a scale Feretti
Time Frame: Day 15
scale Feretti
Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pain using a visual analog scale
Time Frame: Day 15, Day 30 and Day 60
visual analog scale
Day 15, Day 30 and Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Study Director: Pierrick GUILLEMOT, Md, Chu Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2013

Primary Completion (ACTUAL)

August 20, 2015

Study Completion (ACTUAL)

November 6, 2015

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (ESTIMATE)

August 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-A01172-41
  • 35RC12_8971 (OTHER: CHU Rennes)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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