Reliability of the Doha Agreement Classification of Groin Pain

NCT ID: NCT03590145

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-25

Study Completion Date

2021-08-01

Brief Summary

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This study will investigate the reproducibility of a clinical diagnostic classification system for groin pain between two different examiners.

Detailed Description

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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.

Conditions

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Groin Injury Hip Pain Chronic Adductor Tendinitis Inguinal Hernia Iliopsoas Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Qatari athletes

Participants meeting general inclusion criteria.

Clinical examination

Intervention Type DIAGNOSTIC_TEST

Standardized clinical examination consisting of pain provocation test, including palpation, muscle resistance and stretch test.

Interventions

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Clinical examination

Standardized clinical examination consisting of pain provocation test, including palpation, muscle resistance and stretch test.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University College Dublin

OTHER

Sponsor Role collaborator

Aspetar

OTHER

Sponsor Role lead

Responsible Party

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Andreas Serner

Clinical Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johannes Tol, PhD

Role: STUDY_DIRECTOR

Aspetar Orthopaedic and Sports Medicine Hospital

Locations

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Aspetar Orthopaedic and Sports Medicine Hospital

Doha, , Qatar

Site Status

Countries

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Qatar

References

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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.

Reference Type BACKGROUND
PMID: 23403531 (View on PubMed)

Serner 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.

Reference Type BACKGROUND
PMID: 25633830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21478502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23038786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26031643 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 843571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28654441 (View on PubMed)

Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.

Reference Type BACKGROUND
PMID: 15733050 (View on PubMed)

Other Identifiers

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Aspetar

Identifier Type: -

Identifier Source: org_study_id

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