NCT03842826

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 19, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

February 14, 2019

Last Update Submit

February 10, 2025

Conditions

Keywords

Clinical examinationGroinReproducibility

Outcome Measures

Primary Outcomes (1)

  • Cohen's Kappa statistic (κ)

    Inter-examiner reliability

    February 2019 - December 2020

Secondary Outcomes (1)

  • Raw agreement

    February 2019 - December 2020

Study Arms (1)

Athlete

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

Diagnostic Test: Palpation, resistance and stretch tests

Interventions

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

Athlete

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Male athletes with sports-related groin pain ≥ 4 weeks

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspetar Orthopaedic and Sports Medicine Hospital

Doha, 29222, Qatar

Location

Related Publications (10)

  • 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.

    PMID: 26031643BACKGROUND
  • 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.

    PMID: 21514934BACKGROUND
  • 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.

    PMID: 21478502BACKGROUND
  • 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.

    PMID: 15273182BACKGROUND
  • 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.

    PMID: 23038786BACKGROUND
  • 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.

    PMID: 26031644BACKGROUND
  • 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.

    PMID: 29510653BACKGROUND
  • Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

    PMID: 843571BACKGROUND
  • 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.

    PMID: 28654441BACKGROUND
  • Heijboer 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.

MeSH Terms

Interventions

Palpation

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Johannes Tol, MD / PhD

    Aspetar Orthopaedic and Sports Medicine Hospital / Academic Medical Center Amsterdam

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 15, 2019

Study Start

March 19, 2019

Primary Completion

December 1, 2020

Study Completion

March 31, 2024

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations