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CompletedNCT03842826Updated Feb 11, 2025

Inter-examiner Reproducibility of Clinical Examination Tests for Athletes with Longstanding Groin Pain

An observational study in Groin Injury, Adductor Strains and Iliopsoas Syndrome, sponsored by Aspetar. Completed at 1 site in Qatar. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Aspetar · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 40 Years
Sex
Male
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Study 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 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.

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Conditions studied

  • Groin Injury
  • Adductor Strains
  • Iliopsoas Syndrome

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Keywords

  • Clinical examination
  • Groin
  • Reproducibility
03

In context

Sprains and Strains

246 studies on the registry are indexed under Sprains and Strains; 49 are open to participants now.

This study's enrollment of 60 is below the median of 101 across 79 observational studies indexed under Sprains and Strains.

Browse Sprains and Strains studies →

Lead sponsor

Aspetar is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Male athletes with sports-related groin pain ≥ 4 weeks

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male athlete (performing sports ≥ 1x/week) with sports-related groin pain ≥ 4 weeks
  • Age: 18 - 40 years

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Athlete

    Male athletes performing sports ≥ 1x/week Age: 18-40 years

    Diagnostic Test: Palpation, resistance and stretch tests

Interventions

  • Diagnostic testPalpation, resistance and stretch tests

    Palpation, resistance and stretch tests performed by 2 blinded examiners.

06

What researchers measure

Primary outcomes

  1. Cohen's Kappa statistic (κ)

    Inter-examiner reliability

    Time frame: February 2019 - December 2020

Secondary outcomes

  1. Raw agreement

    Absolute positive agreement and negative agreement

    Time frame: February 2019 - December 2020

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Study locations

1 site
  • Aspetar Orthopaedic and Sports Medicine Hospital
    Doha, 29222, Qatar
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References and documents

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 26031643 ↗
  • Kottner 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 21514934 ↗
  • Thorborg 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. Erratum In: Br J Sports Med. 2011 Jul;45(9):742. PubMed 21478502 ↗
  • Holmich 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 15273182 ↗
  • Clarsen 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 23038786 ↗
  • Delahunt 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 26031644 ↗
  • Thorborg 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 29510653 ↗
  • Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. PubMed 843571 ↗
  • Taylor 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 28654441 ↗

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03842826
Lead sponsor
Aspetar
Responsible party
Andreas Serner (Principal Investigator, Aspetar) — Principal investigator
First posted
Feb 15, 2019
Start date
Mar 19, 2019
Primary completion
Dec 1, 2020
Completion
Mar 31, 2024
Last update
Feb 11, 2025

Study contacts

Johannes Tol, MD / PhD
study director · Aspetar Orthopaedic and Sports Medicine Hospital / Academic Medical Center Amsterdam

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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