Groin InjuryFinngroinNCT02560480
Groin Injuries in Finnish Contact Sports
An observational study of Groin Injury, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This observational case-control study follows three contact sport teams (soccer, ice-hockey and bandy) for two years to find out the prevalence and reasons for groin pain. Read more about this study
- Who is it for?
- Ages 16 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Groin Injury
- What is being tested?
- magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2015to 31 Dec 2019
- Phase
- Observational
- 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 40 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: three contact sport teams (male ice-hockey, soccer, bandy)
Who may be able to join
- acute (1-30 days) groin injury
- subacute or chronic groin injury (lasting >30 days)
- pain in the groin or hip area
Who cannot join
- inguinal hernia
- postoperative pain
- metallic plates or screws in the pelvis (MRI impossible)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Groin Injuries in Finnish Contact Sports: Prospective 2-year Clinical and Magnetic Resonance Imaging Study
The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This observational case-control study follows three contact sport teams (soccer, ice-hockey and bandy) for two years to find out the prevalence and reasons for groin pain. Clinical examination, pain scores and pelvic magnetic resonance imaging (MRI) are performed. Hip and groin questionnaire (HAGOS) is used to determine severity of groin injuries.
Read the detailed description
The prevalence of chronic groin pain in athletes and physically active adults is between 5 and 10 %. Common causes include adductor tendonitis, musculus rectus abdominis tendopathy, osteitis pubis (edema on MRI scans at pubic symphysis) or disruption of the posterior wall of inguinal canal or iliopsoas muscle. This observational case-control study follows three contact sports team (male soccer, ice-hockey and bandy) for two years to find out prevalence of acute and chronic groin pain. Adult (>18 years old) male athletes with acute or chronic groin pain during the study pediod are included. Outcome measures are clinical examination, pain scores, exact diagnosis and repeated pelvic MRI (two times) are performed in each patients and three control atheletes in each team. Hip and groin questionnaire (HAGOS) is used to determine the severity of groin injuries. The end-points of study are prevalence of groin injuries and exact diagnosis.
- Conditions
- Groin Injury
- Being tested
- magnetic resonance imaging
- Keywords
- groin pain, groin injury, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingDevice
to diagonose groin injury exactly in magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| groin injury (group A) | magnetic resonance imaging performed in all athletes with acute or subacute groin injury Receives: Device: magnetic resonance imaging | |
| control (group B) | magnetic resonance imaging performed in selected asymptomatic control athletes Receives: Device: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of acute groin injury
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Groin InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Orton Orthopaedic Hospital, Mikkeli Central Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Hannu EK Paajanen, MD, Principal investigator, Department of Surgery, Kuopio Iniversity Hospital, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560480
- Sponsor's protocol ID
- 241/2015
- Acronym
- Finngroin
- Status last verified
- Aug 2019
- First submitted
- 24 Sep 2015
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paajanen H, Hermunen H, Ristolainen L, Branci S. Long-standing groin pain in contact sports: a prospective case-control and MRI study. BMJ Open Sport Exerc Med. 2019 Mar 19;5(1):e000507. doi: 10.1136/bmjsem-2018-000507. eCollection 2019.
PubMed 31191965
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Groin Injuries in Finnish Contact Sports: Prospective 2-year Clinical and Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT02560480
- Acronym / sponsor ID
- Finngroin / 241/2015
- Conditions
- Groin Injury
- Keywords
- groin pain, groin injury, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Orton Orthopaedic Hospital, Mikkeli Central Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Aug 2015
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Sep 2015 (estimated)
- 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.
The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This observational case-control study follows three contact sport teams (soccer, ice-hockey and bandy) for two years to find out the prevalence and reasons for groin pain. Clinical examination, pain scores and pelvic magnetic resonance imaging (MRI) are performed. Hip and groin questionnaire (HAGOS) is used to determine severity of groin injuries.
Detailed description
The prevalence of chronic groin pain in athletes and physically active adults is between 5 and 10 %. Common causes include adductor tendonitis, musculus rectus abdominis tendopathy, osteitis pubis (edema on MRI scans at pubic symphysis) or disruption of the posterior wall of inguinal canal or iliopsoas muscle. This observational case-control study follows three contact sports team (male soccer, ice-hockey and bandy) for two years to find out prevalence of acute and chronic groin pain. Adult (>18 years old) male athletes with acute or chronic groin pain during the study pediod are included. Outcome measures are clinical examination, pain scores, exact diagnosis and repeated pelvic MRI (two times) are performed in each patients and three control atheletes in each team. Hip and groin questionnaire (HAGOS) is used to determine the severity of groin injuries. The end-points of study are prevalence of groin injuries and exact diagnosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| groin injury (group A) | – | Device: magnetic resonance imagingmagnetic resonance imaging performed in all athletes with acute or subacute groin injury |
| control (group B) | – | Device: magnetic resonance imagingmagnetic resonance imaging performed in selected asymptomatic control athletes |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- three contact sport teams (male ice-hockey, soccer, bandy)
Key inclusion criteria (3 listed)
- acute (1-30 days) groin injury
- subacute or chronic groin injury (lasting >30 days)
- pain in the groin or hip area
Key exclusion criteria (3 listed)
- inguinal hernia
- postoperative pain
- metallic plates or screws in the pelvis (MRI impossible)
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 |
|---|---|---|
| magnetic resonance imagingto diagonose groin injury exactly in magnetic resonance imaging | Device | control (group B), groin injury (group A) |
Primary outcome
prevalence of acute groin injury
Time frame: 2 years
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 18 Feb 2021.
- Derived from this study: PubMed 31191965Paajanen H, Hermunen H, Ristolainen L, Branci S. Long-standing groin pain in contact sports: a prospective case-control and MRI study. BMJ Open Sport Exerc Med. 2019 Mar 19;5(1):e000507. doi: 10.1136/bmjsem-2018-000507. eCollection 2019.
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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.
Hannu EK Paajanen, MD principal investigator
Department of Surgery, Kuopio Iniversity Hospital, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Groin Injury, run by Kuopio University Hospital at 1 site in Finland.
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 3 inclusion and 3 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 18 Feb 2021. 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 Finland. 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?
prevalence of acute groin injury (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02560480, which also lists 1 linked publication.
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 18 Feb 2021.