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

Groin Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03842826
• Other study ID #: Aspetar_GPCA001
• Status: Active, not recruiting
• Start date: March 19, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Aspetar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male athlete (performing sports = 1x/week) with sports-related groin pain = 4 weeks

• Age: 18 - 40 years

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

Related Conditions & MeSH terms

• Adductor Strains
• Groin Injury
• Iliopsoas Syndrome

Intervention

Diagnostic Test:
• Palpation, resistance and stretch tests
Palpation, resistance and stretch tests performed by 2 blinded examiners.

Locations

Country	Name	City	State
Qatar	Aspetar Orthopaedic and Sports Medicine Hospital	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Aspetar

Country where clinical trial is conducted

Qatar, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohen's Kappa statistic (?)	Inter-examiner reliability	February 2019 - December 2020
Secondary	Raw agreement	Absolute positive agreement and negative agreement	February 2019 - December 2020