- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05713487
Preventive Treatment of Groin Pain in Football
February 3, 2023 updated by: Luca Puce, Universita degli Studi di Genova
Preventive Treatment of Groin Pain Syndrome in élite Young Football Player: a Pilot Study
Groin pain represents a common issue in football.
Currently, there are no prevention protocols demonstrating real effectiveness.
We aimed to investigate the possible positive effect of a prevention program for groin pain.Forty-two élite male athletes belonging to a youth academy of a professional football club were recruited in this prospective, randomized, controlled, single-blind, study.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
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
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-
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Genova, Italy, 16122
- Universita degli Studi di Genova
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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
16 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- subjects between the ages of sixteen and eighteen, belonging to the youth sector of a professional club.
Exclusion Criteria:
- Presence of pain or injuries at the level of the hip-hip region at the initial assessment.
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: control group
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|
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EXPERIMENTAL: preventive treatment group
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each athlete belonging to the preventive treatment group performed the protocol of preventive treatment 2 times a week, before or after the training session for five months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength in the adductors
Time Frame: One day before the start of the physical protocol and one day after the end of the physical protocol
|
The strength was evaluated in Newton during maximal voluntary isometric contraction used a dynamometer (Activforce 2)
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One day before the start of the physical protocol and one day after the end of the physical protocol
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain in the hip joint
Time Frame: One day before the start of the physical protocol and one day after the end of the physical protocol
|
The pain was rated using the Numeric Pain Rating Scale (NPRS) (0-10; 0 represents no pain and 10 represents maximum pain) during maximal voluntary isometric contraction (Copenhagen five-second squeeze test).
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One day before the start of the physical protocol and one day after the end of the physical protocol
|
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Groin pain
Time Frame: One day before the start of the physical protocol and one day after the end of the physical protocol
|
The pain was rated using the Numeric Pain Rating Scale (NPRS) (0-10; 0 represents no pain and 10 represents maximum pain) during maximal voluntary isometric contraction (Copenhagen five-second squeeze test).
|
One day before the start of the physical protocol and one day after the end of the physical protocol
|
|
Range of motion (ROM) of the hip joint
Time Frame: One day before the start of the physical protocol and one day after the end of the physical protocol
|
ROM was assessed using the distance (cm) from the head of the fibula to the edge of the bed (Bent Knee Fall Out Test)
|
One day before the start of the physical protocol and one day after the end of the physical protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 10, 2022
Primary Completion (ACTUAL)
May 20, 2022
Study Completion (ACTUAL)
December 20, 2022
Study Registration Dates
First Submitted
January 24, 2023
First Submitted That Met QC Criteria
February 3, 2023
First Posted (ACTUAL)
February 6, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- GP-DINOGMI-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.