Inguinal Hernia Clinical Trial
Official title:
Reliability of the Doha Agreement Classification in the Clinical Diagnosis of Groin Pain in Athletes - an Inter-examiner Reproducibility Study.
NCT number | NCT03590145 |
Other study ID # | Aspetar |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 25, 2017 |
Est. completion date | August 1, 2021 |
Verified date | March 2022 |
Source | Aspetar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will investigate the reproducibility of a clinical diagnostic classification system for groin pain between two different examiners.
Status | Completed |
Enrollment | 48 |
Est. completion date | August 1, 2021 |
Est. primary completion date | March 3, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Qatar | Aspetar Orthopaedic and Sports Medicine Hospital | Doha |
Lead Sponsor | Collaborator |
---|---|
Aspetar | University College Dublin |
Qatar,
Branci S, Thorborg K, Nielsen MB, Hölmich 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. Review. — View Citation
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
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. — View Citation
Serner A, van Eijck CH, Beumer BR, Hölmich 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. Review. — View Citation
Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68. Review. — 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, Hölmich 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
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, Hölmich 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
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