Groin InjuryNCT03590145
Reliability of the Doha Agreement Classification of Groin Pain
An observational study of Groin Injury and Hip Pain Chronic, run by Aspetar at 1 site in Qatar.
Trial summary
This study will investigate the reproducibility of a clinical diagnostic classification system for groin pain between two different examiners. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Groin Injury, Hip Pain Chronic, Adductor Tendinitis
- What is being tested?
- Clinical examination
- How many people
- 48 participants
- Where
- 1 siteQatar
- Study dates
- 25 Oct 2017to 1 Aug 2021
- 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Study population: Adult male individuals regularly participating in recreational or elite sports activity (≥once/week) with a current primary complaint of hip and/or groin pain of a non-acute onset that worsens on exercise, or of acute onset, which has not recovered and become longstanding (˃6w).
Who may be able to join
- adult (˃18y) male individuals regularly participating in recreational or elite sports activity (≥once/week).
- current primary complaint of hip and/or groin pain of a non-acute onset that worsens on exercise, or of acute onset, which has not recovered and become longstanding (˃6w).
Who cannot join
- any prior assessment or treatment from one of the examiners for the same complaints.
- fractures or acute injuries with severe pain were it would be unethical to examine the athlete twice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of the Doha Agreement Classification in the Clinical Diagnosis of Groin Pain in Athletes - an Inter-examiner Reproducibility Study.
This study will investigate the reproducibility of a clinical diagnostic classification system for groin pain between two different examiners.
Read the detailed description
Groin pain is prevalent in field and court sport athletes. It is particularly prevalent in soccer, Gaelic football and rugby union. The wide variety of possible injuries in numerous anatomical structures and high prevalence of "abnormal imaging findings" in asymptomatic athletes contribute to the complexity. Heterogeneous taxonomy of groin injuries in athletes adds further to the confusion. Clinical practice is challenging with clinicians using differing groin pain terminology, where even the same term can have multiple interpretations. A recent systematic review on the treatment of groin pain in athletes included 72 studies, in which 33 different diagnostic terms were used. The "Doha agreement meeting on terminology and definitions in groin pain in athletes" was convened to attempt to resolve this problem. The Doha agreement meeting on terminology and definitions in groin pain in athletes reached a consensus on a clinically based taxonomy using three major categories. These definitions and terminology are based on history and physical examination to categorize athletes, making it simple and suitable for both clinical practice and research.
The purpose of this study is therefore to investigate the inter-examiner reliability of the "Doha agreement meeting on terminology and definitions in groin pain in athletes." The study will be performed at a Sports Medicine Hospital in Qatar.
Prior to the clinical examination participants will be requested to complete the Copenhagen Hip and Groin Outcome Score (HAGOS). This is a patient-reported outcome measure, which quantifies a patient's current subjective perception of their hip and groin pain within the last week on six subscales, each with a score between 0 and 100. Additionally, participants will be requested to complete the Oslo Sports Trauma Research Center (OSTRC) overuse injury questionnaire with a focus on groin problems within the last week.
A standardized clinical examination will be performed. Palpation, resistance testing and stretching of affected muscle groups are used to categorize athletes into defined clinical entities. The pain reported by the athlete during the tests should also be felt in the affected structure. For example, in adductor-related groin pain, the pain on resisted adduction testing should reproduce the athlete's recognizable pain in the adductors. Pain felt in a different location-for example, the inguinal region on resisted adduction testing-would not signify adductor-related groin pain.
Statistical analyses Cohen's Kappa statistic (κ) is used to signify agreement between clinicians. Agreement was considered almost perfect if κ=0.81-1.00, moderate κ=0.41-0.60, substantial κ=0.61-0.80, fair κ=0.21-0.40, slight κ=0-0.20, and poor if κ<0. In addition, absolute agreement, prevalence, and bias index will be calculated. Statistical analyses will be performed using SPSS software.
Sample size With two examiners at each site, an expected Kappa of at least 0.8 with a lower limit of a 95% confidence interval of 0.4, and an expected prevalence between 0.3-0.7 for the three expected main defined clinical entities (adductor-related, inguinal-related, and iliopsoas-related groin pain), assuming no bias between examiners, the required sample size is determined to be 48 using a 2-tailed test. As pubic-related and hip-related groin pain is expected to be less frequent, a lower limit confidence interval of 0 for these entities is accepted, which in a 1-tailed test, maintaining an expected kappa of 0.8, requires a sample of only 10 participants. Thus 48 participants will be included.
- Being tested
- Clinical examination
- Keywords
- Groin pain, Adductor-related, Inguinal-related, Pubic-related, Iliopsoas-related, Hip-related
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationDiagnostic test
Standardized clinical examination consisting of pain provocation test, including palpation, muscle resistance and stretch test.
| Study group | Role | What they receive |
|---|---|---|
| Qatari athletes | Participants meeting general inclusion criteria. Receives: Diagnostic Test: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical entity
Patients are diagnosed with one or multiple clinical entities:
"Adductor-related" (adductor tenderness AND pain on resisted adduction testing), "Pubic-related" (local tenderness of the pubic symphysis and the immediately adjacent bone), "Iliopsoas-related" (iliopsoas tenderness AND more likely with pain on resisted hip flexion AND/OR pain on stretching of the iliopsoas), "Inguinal-related" (pain location in the inguinal canal region AND tenderness of the inguinal canal. No palpable inguinal hernia. More likely if the pain is aggravated with resistance testing of the abdominal muscles OR on Valsalva/cough/sneeze), or "Hip-related" (clinical suspicion, either through history or clinical examination. Specific diagnosis will require further investigations and will not be included in this study), or "Other" (any cause of groin pain which cannot be included with in the specified clinical entities).
Measured: Oct 2017 - June 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start25 Oct 2017
- Primary completion3 Mar 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 only
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspetar
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Responsible party
- Principal investigator, Andreas Serner, Aspetar
- Investigators
- Johannes Tol, PhD, Study director, Aspetar Orthopaedic and Sports Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590145
- Sponsor's protocol ID
- Aspetar
- Status last verified
- Mar 2022
- First submitted
- 26 Jun 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is currently no plan of sharing individual participant data; however, upon reasonable request, anonymized data can be made available for interested parties.
Publications
Branci S, Thorborg K, Nielsen MB, Holmich P. Radiological findings in symphyseal and adductor-related groin pain in athletes: a critical review of the literature. Br J Sports Med. 2013 Jul;47(10):611-9. doi: 10.1136/bjsports-2012-091905. Epub 2013 Feb 12.
PubMed 23403531Serner A, van Eijck CH, Beumer BR, Holmich P, Weir A, de Vos RJ. Study quality on groin injury management remains low: a systematic review on treatment of groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):813. doi: 10.1136/bjsports-2014-094256. Epub 2015 Jan 29.
PubMed 25633830Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.
PubMed 21478502Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.
PubMed 23038786Weir A, Brukner P, Delahunt E, Ekstrand J, Griffin D, Khan KM, Lovell G, Meyers WC, Muschaweck U, Orchard J, Paajanen H, Philippon M, Reboul G, Robinson P, Schache AG, Schilders E, Serner A, Silvers H, Thorborg K, Tyler T, Verrall G, de Vos RJ, Vuckovic Z, Holmich P. Doha agreement meeting on terminology and definitions in groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):768-74. doi: 10.1136/bjsports-2015-094869.
PubMed 26031643Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
PubMed 843571Taylor R, Vuckovic Z, Mosler A, Agricola R, Otten R, Jacobsen P, Holmich P, Weir A. Multidisciplinary Assessment of 100 Athletes With Groin Pain Using the Doha Agreement: High Prevalence of Adductor-Related Groin Pain in Conjunction With Multiple Causes. Clin J Sport Med. 2018 Jul;28(4):364-369. doi: 10.1097/JSM.0000000000000469.
PubMed 28654441Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.
PubMed 15733050
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Doha Agreement Classification in the Clinical Diagnosis of Groin Pain in Athletes - an Inter-examiner Reproducibility Study.
- ClinicalTrials.gov ID
- NCT03590145
- Acronym / sponsor ID
- Aspetar
- Keywords
- Groin pain, Adductor-related, Inguinal-related, Pubic-related, Iliopsoas-related, Hip-related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AspetarUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 18 Jul 2018 (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.
This study will investigate the reproducibility of a clinical diagnostic classification system for groin pain between two different examiners.
Detailed description
Groin pain is prevalent in field and court sport athletes. It is particularly prevalent in soccer, Gaelic football and rugby union. The wide variety of possible injuries in numerous anatomical structures and high prevalence of "abnormal imaging findings" in asymptomatic athletes contribute to the complexity. Heterogeneous taxonomy of groin injuries in athletes adds further to the confusion. Clinical practice is challenging with clinicians using differing groin pain terminology, where even the same term can have multiple interpretations. A recent systematic review on the treatment of groin pain in athletes included 72 studies, in which 33 different diagnostic terms were used. The "Doha agreement meeting on terminology and definitions in groin pain in athletes" was convened to attempt to resolve this problem. The Doha agreement meeting on terminology and definitions in groin pain in athletes reached a consensus on a clinically based taxonomy using three major categories. These definitions and terminology are based on history and physical examination to categorize athletes, making it simple and suitable for both clinical practice and research.
The purpose of this study is therefore to investigate the inter-examiner reliability of the "Doha agreement meeting on terminology and definitions in groin pain in athletes." The study will be performed at a Sports Medicine Hospital in Qatar.
Prior to the clinical examination participants will be requested to complete the Copenhagen Hip and Groin Outcome Score (HAGOS). This is a patient-reported outcome measure, which quantifies a patient's current subjective perception of their hip and groin pain within the last week on six subscales, each with a score between 0 and 100. Additionally, participants will be requested to complete the Oslo Sports Trauma Research Center (OSTRC) overuse injury questionnaire with a focus on groin problems within the last week.
A standardized clinical examination will be performed. Palpation, resistance testing and stretching of affected muscle groups are used to categorize athletes into defined clinical entities. The pain reported by the athlete during the tests should also be felt in the affected structure. For example, in adductor-related groin pain, the pain on resisted adduction testing should reproduce the athlete's recognizable pain in the adductors. Pain felt in a different location-for example, the inguinal region on resisted adduction testing-would not signify adductor-related groin pain.
Statistical analyses Cohen's Kappa statistic (κ) is used to signify agreement between clinicians. Agreement was considered almost perfect if κ=0.81-1.00, moderate κ=0.41-0.60, substantial κ=0.61-0.80, fair κ=0.21-0.40, slight κ=0-0.20, and poor if κ<0. In addition, absolute agreement, prevalence, and bias index will be calculated. Statistical analyses will be performed using SPSS software.
Sample size With two examiners at each site, an expected Kappa of at least 0.8 with a lower limit of a 95% confidence interval of 0.4, and an expected prevalence between 0.3-0.7 for the three expected main defined clinical entities (adductor-related, inguinal-related, and iliopsoas-related groin pain), assuming no bias between examiners, the required sample size is determined to be 48 using a 2-tailed test. As pubic-related and hip-related groin pain is expected to be less frequent, a lower limit confidence interval of 0 for these entities is accepted, which in a 1-tailed test, maintaining an expected kappa of 0.8, requires a sample of only 10 participants. Thus 48 participants will be included.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qatari athletes | – | Diagnostic Test: Clinical examinationParticipants meeting general inclusion criteria. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult male individuals regularly participating in recreational or elite sports activity (≥once/week) with a current primary complaint of hip and/or groin pain of a non-acute onset that worsens on exercise, or of acute onset, which has not recovered and become longstanding (˃6w).
Key inclusion criteria (2 listed)
- adult (˃18y) male individuals regularly participating in recreational or elite sports activity (≥once/week).
- current primary complaint of hip and/or groin pain of a non-acute onset that worsens on exercise, or of acute onset, which has not recovered and become longstanding (˃6w).
Key exclusion criteria (2 listed)
- any prior assessment or treatment from one of the examiners for the same complaints.
- fractures or acute injuries with severe pain were it would be unethical to examine the athlete twice.
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 |
|---|---|---|
| Clinical examinationStandardized clinical examination consisting of pain provocation test, including palpation, muscle resistance and stretch test. | Diagnostic test | Qatari athletes |
Primary outcome
Clinical entity
Time frame: Oct 2017 - June 2019
Patients are diagnosed with one or multiple clinical entities: "Adductor-related" (adductor tenderness AND pain on resisted adduction testing), "Pubic-related" (local tenderness of the pubic symphysis and the immediately adjacent bone), "Iliopsoas-related" (iliopsoas tenderness AND more likely with pain on resisted hip flexion AND/OR pain on stretching of the iliopsoas), "Inguinal-related" (pain location in the inguinal canal region AND tenderness of the inguinal canal. No palpable inguinal hernia. More likely if the pain is aggravated with resistance testing of the abdominal muscles OR on Valsalva/cough/sneeze), or "Hip-related" (clinical suspicion, either through history or clinical examination. Specific diagnosis will require further investigations and will not be included in this study), or "Other" (any cause of groin pain which cannot be included with in the specified clinical entities).
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 16 Mar 2022.
- Background: PubMed 23403531Branci S, Thorborg K, Nielsen MB, Holmich P. Radiological findings in symphyseal and adductor-related groin pain in athletes: a critical review of the literature. Br J Sports Med. 2013 Jul;47(10):611-9. doi: 10.1136/bjsports-2012-091905. Epub 2013 Feb 12.
- Background: PubMed 25633830Serner A, van Eijck CH, Beumer BR, Holmich P, Weir A, de Vos RJ. Study quality on groin injury management remains low: a systematic review on treatment of groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):813. doi: 10.1136/bjsports-2014-094256. Epub 2015 Jan 29.
- Background: PubMed 21478502Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.
- Background: PubMed 23038786Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.
- Background: PubMed 26031643Weir A, Brukner P, Delahunt E, Ekstrand J, Griffin D, Khan KM, Lovell G, Meyers WC, Muschaweck U, Orchard J, Paajanen H, Philippon M, Reboul G, Robinson P, Schache AG, Schilders E, Serner A, Silvers H, Thorborg K, Tyler T, Verrall G, de Vos RJ, Vuckovic Z, Holmich P. Doha agreement meeting on terminology and definitions in groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):768-74. doi: 10.1136/bjsports-2015-094869.
- Background: PubMed 843571Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
- Background: PubMed 28654441Taylor R, Vuckovic Z, Mosler A, Agricola R, Otten R, Jacobsen P, Holmich P, Weir A. Multidisciplinary Assessment of 100 Athletes With Groin Pain Using the Doha Agreement: High Prevalence of Adductor-Related Groin Pain in Conjunction With Multiple Causes. Clin J Sport Med. 2018 Jul;28(4):364-369. doi: 10.1097/JSM.0000000000000469.
- Background: PubMed 15733050Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.
- Individual participant dataSharing planned: Undecided. There is currently no plan of sharing individual participant data; however, upon reasonable request, anonymized data can be made available for interested parties.
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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.
Johannes Tol, PhD study director
Aspetar Orthopaedic and Sports Medicine Hospital
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 and Hip Pain Chronic, run by Aspetar at 1 site in Qatar.
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 2 inclusion and 2 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 16 Mar 2022. 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 Qatar. 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?
Clinical entity (time frame: Oct 2017 - June 2019). 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 NCT03590145, which also lists 8 linked publications.
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 16 Mar 2022.