NCT03590145

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Typical duration 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

Study Start

First participant enrolled

October 25, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

June 26, 2018

Last Update Submit

March 15, 2022

Conditions

Keywords

Groin painAdductor-relatedInguinal-relatedPubic-relatedIliopsoas-relatedHip-related

Outcome Measures

Primary Outcomes (1)

  • Clinical entity

    Patients are diagnosed with one or multiple clinical entities: "Adductor-related" (adductor tenderness AND pain on resisted adduction testing), "Pubic-related" (local tenderness of the pubic symphysis and the immediately adjacent bone), "Iliopsoas-related" (iliopsoas tenderness AND more likely with pain on resisted hip flexion AND/OR pain on stretching of the iliopsoas), "Inguinal-related" (pain location in the inguinal canal region AND tenderness of the inguinal canal. No palpable inguinal hernia. More likely if the pain is aggravated with resistance testing of the abdominal muscles OR on Valsalva/cough/sneeze), or "Hip-related" (clinical suspicion, either through history or clinical examination. Specific diagnosis will require further investigations and will not be included in this study), or "Other" (any cause of groin pain which cannot be included with in the specified clinical entities).

    Oct 2017 - June 2019

Study Arms (1)

Qatari athletes

Participants meeting general inclusion criteria.

Diagnostic Test: Clinical examination

Interventions

Clinical examinationDIAGNOSTIC_TEST

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

Qatari athletes

Eligibility Criteria

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

Adult male individuals regularly participating in recreational or elite sports activity (≥once/week) with a 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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspetar Orthopaedic and Sports Medicine Hospital

Doha, 29222, Qatar

Location

Related Publications (8)

  • 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.

    PMID: 23403531BACKGROUND
  • 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.

    PMID: 25633830BACKGROUND
  • 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
  • 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
  • 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
  • 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
  • Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.

    PMID: 15733050BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Johannes Tol, PhD

    Aspetar Orthopaedic and Sports Medicine Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Scientist

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 18, 2018

Study Start

October 25, 2017

Primary Completion

March 3, 2020

Study Completion

August 1, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations