NCT05713487

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

January 24, 2023

Last Update Submit

February 3, 2023

Conditions

Healthy

Keywords

Groin injuries, soccer, athletes, pain, muscle strength

Outcome Measures

Primary Outcomes (1)

  • Strength in the adductors

    The strength was evaluated in Newton during maximal voluntary isometric contraction used a dynamometer (Activforce 2)

    One day before the start of the physical protocol and one day after the end of the physical protocol

Secondary Outcomes (3)

  • Pain in the hip joint

    One day before the start of the physical protocol and one day after the end of the physical protocol

  • Groin pain

    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

    One day before the start of the physical protocol and one day after the end of the physical protocol

Study Arms (2)

preventive treatment group

EXPERIMENTAL
Other: preventive treatment group

control group

NO INTERVENTION

Interventions

preventive treatment groupOTHER

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

preventive treatment group

Eligibility Criteria

Age16 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • subjects between the ages of sixteen and eighteen, belonging to the youth sector of a professional club.

You may not qualify if:

  • Presence of pain or injuries at the level of the hip-hip region at the initial assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi di Genova

Genova, 16122, Italy

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 6, 2023

Study Start

January 10, 2022

Primary Completion

May 20, 2022

Study Completion

December 20, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)