Groin InjuryNCT03842826
Inter-examiner Reproducibility of Clinical Examination Tests for Athletes with Longstanding Groin Pain
An observational study of Groin Injury and Adductor Strains, run by Aspetar at 1 site in Qatar.
Trial summary
This study will investigate the reproducibility of clinical palpation, resistance and stretching tests which are currently being used for the diagnosis of longstanding groin pain in male athletes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Groin Injury, Adductor Strains, Iliopsoas Syndrome
- What is being tested?
- Palpation, resistance and stretch tests
- How many people
- 60 participants
- Where
- 1 siteQatar
- Study dates
- 19 Mar 2019to 31 Mar 2024
- 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: Male athletes with sports-related groin pain ≥ 4 weeks
Who may be able to join
- Male athlete (performing sports ≥ 1x/week) with sports-related groin pain ≥ 4 weeks
- Age: 18 - 40 years
Who cannot join
- Prior assessment/treatment of one of the two examiners for the same complaint (<6 months)
- Prior surgery in the hip- and groin area
- Clinical signs of prostatitis or urinary tract infections
- More than 7 days between the two examiners assessment
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the reproducibility of clinical palpation, resistance and stretching tests which are currently being used for the diagnosis of longstanding groin pain in male athletes.
Read the detailed description
The "Doha agreement meeting on terminology and definitions" aimed to simplify the heterogeneous taxonomy of groin injuries by creating a straightforward classification system based on patient history and clinical examination. Following this classification system, groin pain can be divided into four defined clinical entities (adductor-, inguinal-, iliopsoas- and/or pubic-related groin pain), hip related groin pain, and/or other causes for groin pain.
In the Doha classification, pain on palpation, resistance and/or stretching are the key clinical findings for categorizing in the four clinical entities. However, this classification does not describe how these clinical tests should be performed and if these tests are reproducible.
The primary aim of this study is to evaluate the inter-examiner reproducibility of clinical palpation, resistance and stretch tests for longstanding groin pain in athletes. The secondary aim is to identify the proportion of positive clinical tests for each clinical entity diagnosis.
Two blinded examiners (a physiotherapist and a general surgeon, both specialized in groin injuries with >10 years experience) will assess each athlete with longstanding groin pain following a standardized examination protocol. Prior to clinical examination, participants will be requested to complete a standardized form for patient/injury characteristics and injury history, the Copenhagen Hip and Groin Outcome Score (HAGOS) and the Oslo Sports Trauma Research Center (OSTRC) overuse injury questionnaire. The HAGOS 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.The OSTRC overuse injury questionnaire has a focus on groin problems within the last week.
The standardized clinical examination protocol consists of palpation, resistance and stretch-tests and are used to categorize athletes into defined clinical entities. A score on the Numeric Pain Rating Scale (0-10) will be asked to the patient for each test, where pain during the test has to correspond to the injury pain. Each score from 1-10 will be considered as positive for analysis. If the pain is just from palpation and not related to the injury, the test will be considered negative.
Inter-examiner reliability will be analysed using Cohen's Kappa statistic (κ), including 95% confidence intervals for dichotomous variables. Linear weighted κ will be calculated for ordinal variables. Additionally, the absolute positive agreement and negative agreement between the two examiners and bias index will be calculated. The mean prevalence of each positive clinical tests of both clinicians will be reported for each entity diagnosis. Furthermore, agreement analysis for the palpation tests of the four defined clinical entities of groin pain will also be grouped: adductor-, iliopsoas-, inguinal- (with and without invagination) and pubic palpation.
For the 3 main defined clinical entities (adductor-, inguinal- and iliopsoas-related groin pain), a prevalence is expected between 30-60% in our research population. Assuming that approximately 4 out of every 5 tests (80%) targeting each entity will be positive, we expect a prevalence of positive tests of approximately 24-48% in the whole sample. With an expected Kappa of at least 0.8, with a 95% confidence interval lower limit of 0.4, using a 2-tailed test and assuming no bias between examiners, at least 60 affected sides will be needed for this study. A lower prevalence of positive tests for pubic-related groin pain and subsequent less robust results for clinical tests of this entity will be accepted. No dropout is expected due to the cross-sectional character of the study. We will continue inclusion until we have 60 full data sets.
- Conditions
- Groin Injury, Adductor Strains, Iliopsoas Syndrome
- Being tested
- Palpation, resistance and stretch tests
- Keywords
- Clinical examination, Groin, Reproducibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palpation, resistance and stretch testsDiagnostic test
Palpation, resistance and stretch tests performed by 2 blinded examiners.
| Study group | Role | What they receive |
|---|---|---|
| Athlete | Male athletes performing sports ≥ 1x/week Age: 18-40 years Receives: Diagnostic Test: Palpation, resistance and stretch tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen's Kappa statistic (κ)
Inter-examiner reliability
Measured: February 2019 - December 2020
Secondary outcomes (1)
Raw agreement
Absolute positive agreement and negative agreement
Measured: February 2019 - December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start19 Mar 2019
- Primary completion1 Dec 2020
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspetar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Serner, Aspetar
- Investigators
- Johannes Tol, MD / PhD, Study director, Aspetar Orthopaedic and Sports Medicine Hospital / Academic Medical Center Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842826
- Sponsor's protocol ID
- Aspetar_GPCA001
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2019
- Last updated
- 11 Feb 2025
- 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
Weir 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 26031643Kottner J, Audige L, Brorson S, Donner A, Gajewski BJ, Hrobjartsson A, Roberts C, Shoukri M, Streiner DL. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. Int J Nurs Stud. 2011 Jun;48(6):661-71. doi: 10.1016/j.ijnurstu.2011.01.016. Epub 2011 Apr 23.
PubMed 21514934Thorborg 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 21478502Holmich P, Holmich LR, Bjerg AM. Clinical examination of athletes with groin pain: an intraobserver and interobserver reliability study. Br J Sports Med. 2004 Aug;38(4):446-51. doi: 10.1136/bjsm.2003.004754.
PubMed 15273182Clarsen 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 23038786Delahunt E, Thorborg K, Khan KM, Robinson P, Holmich P, Weir A. Minimum reporting standards for clinical research on groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):775-81. doi: 10.1136/bjsports-2015-094839.
PubMed 26031644Thorborg K, Reiman MP, Weir A, Kemp JL, Serner A, Mosler AB, HOlmich P. Clinical Examination, Diagnostic Imaging, and Testing of Athletes With Groin Pain: An Evidence-Based Approach to Effective Management. J Orthop Sports Phys Ther. 2018 Apr;48(4):239-249. doi: 10.2519/jospt.2018.7850. Epub 2018 Mar 6.
PubMed 29510653Landis 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 28654441Heijboer WMP, Vuckovic Z, Weir A, Tol JL, Holmich P, Serner A. Clinical examination for athletes with inguinal-related groin pain: interexaminer reliability and prevalence of positive tests. BMJ Open Sport Exerc Med. 2023 Jan 11;9(1):e001498. doi: 10.1136/bmjsem-2022-001498. eCollection 2023.
PubMed 36643406
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-examiner Reproducibility of Clinical Examination Tests for Athletes with Longstanding Groin Pain
- ClinicalTrials.gov ID
- NCT03842826
- Acronym / sponsor ID
- Aspetar_GPCA001
- Conditions
- Groin Injury, Adductor Strains, Iliopsoas Syndrome
- Keywords
- Clinical examination, Groin, Reproducibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AspetarUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 15 Feb 2019 (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 clinical palpation, resistance and stretching tests which are currently being used for the diagnosis of longstanding groin pain in male athletes.
Detailed description
The "Doha agreement meeting on terminology and definitions" aimed to simplify the heterogeneous taxonomy of groin injuries by creating a straightforward classification system based on patient history and clinical examination. Following this classification system, groin pain can be divided into four defined clinical entities (adductor-, inguinal-, iliopsoas- and/or pubic-related groin pain), hip related groin pain, and/or other causes for groin pain.
In the Doha classification, pain on palpation, resistance and/or stretching are the key clinical findings for categorizing in the four clinical entities. However, this classification does not describe how these clinical tests should be performed and if these tests are reproducible.
The primary aim of this study is to evaluate the inter-examiner reproducibility of clinical palpation, resistance and stretch tests for longstanding groin pain in athletes. The secondary aim is to identify the proportion of positive clinical tests for each clinical entity diagnosis.
Two blinded examiners (a physiotherapist and a general surgeon, both specialized in groin injuries with >10 years experience) will assess each athlete with longstanding groin pain following a standardized examination protocol. Prior to clinical examination, participants will be requested to complete a standardized form for patient/injury characteristics and injury history, the Copenhagen Hip and Groin Outcome Score (HAGOS) and the Oslo Sports Trauma Research Center (OSTRC) overuse injury questionnaire. The HAGOS 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.The OSTRC overuse injury questionnaire has a focus on groin problems within the last week.
The standardized clinical examination protocol consists of palpation, resistance and stretch-tests and are used to categorize athletes into defined clinical entities. A score on the Numeric Pain Rating Scale (0-10) will be asked to the patient for each test, where pain during the test has to correspond to the injury pain. Each score from 1-10 will be considered as positive for analysis. If the pain is just from palpation and not related to the injury, the test will be considered negative.
Inter-examiner reliability will be analysed using Cohen's Kappa statistic (κ), including 95% confidence intervals for dichotomous variables. Linear weighted κ will be calculated for ordinal variables. Additionally, the absolute positive agreement and negative agreement between the two examiners and bias index will be calculated. The mean prevalence of each positive clinical tests of both clinicians will be reported for each entity diagnosis. Furthermore, agreement analysis for the palpation tests of the four defined clinical entities of groin pain will also be grouped: adductor-, iliopsoas-, inguinal- (with and without invagination) and pubic palpation.
For the 3 main defined clinical entities (adductor-, inguinal- and iliopsoas-related groin pain), a prevalence is expected between 30-60% in our research population. Assuming that approximately 4 out of every 5 tests (80%) targeting each entity will be positive, we expect a prevalence of positive tests of approximately 24-48% in the whole sample. With an expected Kappa of at least 0.8, with a 95% confidence interval lower limit of 0.4, using a 2-tailed test and assuming no bias between examiners, at least 60 affected sides will be needed for this study. A lower prevalence of positive tests for pubic-related groin pain and subsequent less robust results for clinical tests of this entity will be accepted. No dropout is expected due to the cross-sectional character of the study. We will continue inclusion until we have 60 full data sets.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athlete | – | Diagnostic Test: Palpation, resistance and stretch testsMale athletes performing sports ≥ 1x/week Age: 18-40 years |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male athletes with sports-related groin pain ≥ 4 weeks
Key inclusion criteria (2 listed)
- Male athlete (performing sports ≥ 1x/week) with sports-related groin pain ≥ 4 weeks
- Age: 18 - 40 years
Key exclusion criteria (4 listed)
- Prior assessment/treatment of one of the two examiners for the same complaint (<6 months)
- Prior surgery in the hip- and groin area
- Clinical signs of prostatitis or urinary tract infections
- More than 7 days between the two examiners 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 |
|---|---|---|
| Palpation, resistance and stretch testsPalpation, resistance and stretch tests performed by 2 blinded examiners. | Diagnostic test | Athlete |
Primary outcome
Cohen's Kappa statistic (κ)
Time frame: February 2019 - December 2020
Inter-examiner reliability
1 secondary outcome
Raw agreement
Time frame: February 2019 - December 2020
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 11 Feb 2025.
- 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 21514934Kottner J, Audige L, Brorson S, Donner A, Gajewski BJ, Hrobjartsson A, Roberts C, Shoukri M, Streiner DL. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. Int J Nurs Stud. 2011 Jun;48(6):661-71. doi: 10.1016/j.ijnurstu.2011.01.016. Epub 2011 Apr 23.
- 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 15273182Holmich P, Holmich LR, Bjerg AM. Clinical examination of athletes with groin pain: an intraobserver and interobserver reliability study. Br J Sports Med. 2004 Aug;38(4):446-51. doi: 10.1136/bjsm.2003.004754.
- 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 26031644Delahunt E, Thorborg K, Khan KM, Robinson P, Holmich P, Weir A. Minimum reporting standards for clinical research on groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):775-81. doi: 10.1136/bjsports-2015-094839.
- Background: PubMed 29510653Thorborg K, Reiman MP, Weir A, Kemp JL, Serner A, Mosler AB, HOlmich P. Clinical Examination, Diagnostic Imaging, and Testing of Athletes With Groin Pain: An Evidence-Based Approach to Effective Management. J Orthop Sports Phys Ther. 2018 Apr;48(4):239-249. doi: 10.2519/jospt.2018.7850. Epub 2018 Mar 6.
- 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.
- Derived from this study: PubMed 36643406Heijboer WMP, Vuckovic Z, Weir A, Tol JL, Holmich P, Serner A. Clinical examination for athletes with inguinal-related groin pain: interexaminer reliability and prevalence of positive tests. BMJ Open Sport Exerc Med. 2023 Jan 11;9(1):e001498. doi: 10.1136/bmjsem-2022-001498. eCollection 2023.
- 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, MD / PhD study director
Aspetar Orthopaedic and Sports Medicine Hospital / Academic Medical Center Amsterdam
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 Adductor Strains, 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 4 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 11 Feb 2025. 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?
Cohen's Kappa statistic (κ) (time frame: February 2019 - December 2020). 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 NCT03842826, which also lists 10 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 11 Feb 2025.