HealthyNCT05713487
Preventive Treatment of Groin Pain in Football
A study testing preventive treatment group in people with Healthy, run by Universita degli Studi di Genova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- preventive treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2022to 20 Dec 2022
- Phase
- Interventional
- 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 16 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- subjects between the ages of sixteen and eighteen, belonging to the youth sector of a professional club.
Who cannot join
- Presence of pain or injuries at the level of the hip-hip region at the initial assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- preventive treatment group
- Keywords
- Groin injuries, soccer, athletes, pain, muscle strength
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| preventive treatment group | Experimental | Not described Receives: Other: preventive treatment group |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength in the adductors
The strength was evaluated in Newton during maximal voluntary isometric contraction used a dynamometer (Activforce 2)
Measured: 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
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).
Measured: One day before the start of the physical protocol and one day after the end of the physical protocol
Groin pain
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).
Measured: 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
ROM was assessed using the distance (cm) from the head of the fibula to the edge of the bed (Bent Knee Fall Out Test)
Measured: One day before the start of the physical protocol and one day after the end of the physical protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start10 Jan 2022
- Primary completion20 May 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Puce, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713487
- Sponsor's protocol ID
- GP-DINOGMI-23
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Treatment of Groin Pain Syndrome in élite Young Football Player: a Pilot Study
- ClinicalTrials.gov ID
- NCT05713487
- Acronym / sponsor ID
- GP-DINOGMI-23
- Conditions
- Healthy
- Keywords
- Groin injuries, soccer, athletes, pain, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 6 Feb 2023 (actual)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preventive treatment group | Experimental | Other: preventive treatment group |
| control group | No intervention | – |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- subjects between the ages of sixteen and eighteen, belonging to the youth sector of a professional club.
Key exclusion criteria (1 listed)
- Presence of pain or injuries at the level of the hip-hip region at the initial assessment.
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 |
|---|---|---|
| preventive treatment groupeach 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 | Other | preventive treatment group |
Primary outcome
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)
3 secondary outcomes
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
Groin pain
Time frame: 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
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 6 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preventive treatment group in people with Healthy, run by Universita degli Studi di Genova at 1 site in Italy.
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 1 inclusion and 1 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 6 Feb 2023. 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 Italy. 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.
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?
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). 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 6 Feb 2023.