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

July 23, 2023 updated by: Andreas Serner, Aspetar
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 29222
        • Aspetar Orthopaedic and Sports Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Male athletes with sports-related groin pain ≥ 4 weeks

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Athlete
Male athletes performing sports ≥ 1x/week Age: 18-40 years
Diagnostic test: Palpation, resistance and stretch tests
Palpation, resistance and stretch tests performed by 2 blinded examiners.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen's Kappa statistic (κ)
Time Frame: February 2019 - December 2020
Inter-examiner reliability
February 2019 - December 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Raw agreement
Time Frame: February 2019 - December 2020
Absolute positive agreement and negative agreement
February 2019 - December 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aspetar

Investigators

  • Study Director: Johannes Tol, MD / PhD, Aspetar Orthopaedic and Sports Medicine Hospital / Academic Medical Center Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aspetar_GPCA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There is currently no plan of sharing individual participant data; however, upon reasonable request, anonymized data can be made available for interested parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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