NCT02437942

Brief Summary

Athletic groin pain (AGP) is a chronic condition common in multi-directional sports (Walden et al. 2007, Robinson et al. 2004, Murphy et al. 2012). It is a complex injury with a challenging diagnosis. Dramatic differences in the anatomical diagnoses of AGP cohorts exist in the literature (Renstrom et al. 1980, Lovell et al. 1995, Holmich et al. 2007, Bradshaw et al. 2008). This may be due to the complexity of the anatomy in the region and the absence of magnetic resonance imaging (MAGNETIC RESONANCE IMAGE) to confirm clinical examination. Dynamic actions undertaken in field sports (including change of direction cutting) are particularly associated with the development of athletic groin pain (Holmich et al. 2014). Dynamic multi-plane, multi-joint actions can overload musculoskeletal and fascial structures in the hip and groin. Despite this, traditional groin pain assessments do not involve an examination of sport specific actions. An examination of jumping, hopping and cutting mechanics, which is possible with the use of three dimensional motion capture techniques, will provide additional information with which to diagnosis and rehabilitate athletes. While the majority of published studies on AGP have focused on surgical management (Serner et al. 2015), exercise therapy has been found to be an effective treatment (Holmich et al. 1995). In exercise therapy studies the best results were shown by Holmich et al (1995) where subjects suffered for an average of 9.9 months with symptoms and a strength and stability program focused on adductor strength returned them to sport in 18.5 weeks. The latest paper on rehabilitation by Jardi et al. demonstrates little improvement with a mean time to return to training of 86 days +/-15. The focus remains on improving strength of isolated muscle groups and not attempting to address underlying biomechanical abnormalities that may be leading to overload. Accurate biomechanical assessment and individualized rehabilitation based on the high speed multiplanar movements that drive the athlete's symptoms may enhance the efficiency of rehabilitation. Moreover post-rehabilitation changes in biomechanical factors may provide a further insight into the biomechanical factors associated with AGP. The purpose of this study was to:

  1. 1.Describe clinical presentation (physical examination and magnetic resonance imaging findings) for a group of athletes presenting with AGP
  2. 2.To describe the different biomechanical diagnoses that exist in AGP patients
  3. 3.To examine the effects of a biomechanics led exercise intervention to rehabilitate chronic groin pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

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

April 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

7.4 years

First QC Date

April 29, 2015

Last Update Submit

April 18, 2024

Conditions

Keywords

Athletic injurieschronicrehabilitationdiagnosisbiomechanics

Outcome Measures

Primary Outcomes (1)

  • Hip and groin outcome score (HAGOS)

    The HAGOS questionnaire is a validated tool (Thorborg et al. 2014; Thorborg et al. 2011) used to examine the impact of injury on physical function and to track symptoms at the time of diagnosis and as rehabilitation progresses.

    Over the course of the rehabilitation time frame and one year and two years post initial consultation

Secondary Outcomes (1)

  • Kinetic and kinematic composite score

    Following rehabilitation, an expected average of 10 weeks

Other Outcomes (4)

  • Hip range of movement

    Following rehabilitation, an expected average of 10 weeks

  • Hip strength

    Following rehabilitation, an expected average of 10 weeks

  • Squeeze test

    Following rehabilitation, an expected average of 10 weeks

  • +1 more other outcomes

Study Arms (1)

Biomechanics led physical therapy rehabilitation

EXPERIMENTAL

Physical therapy exercise rehabilitation

Other: Biomechanics led physical therapy rehabilitation

Interventions

Rehabilitation intervention will consist of movement control (3 days per week), whole body strength and power (2 days per week), linear running mechanics (3 days per week), multi-directional mechanics (3 days per week), conditioning sessions (2 days per week). Rehabilitation will continue until physical therapist deems the athlete ready to return to sport.

Biomechanics led physical therapy rehabilitation

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of athletic groin pain
  • Professional athlete in full time training with groin pain diagnosis

You may not qualify if:

  • Post infective osteitis
  • Bone tumour
  • Acute injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Surgery Clinic

Dublin, Leinster, Ireland

Location

Related Publications (15)

  • Bradshaw CJ, Bundy M, Falvey E. The diagnosis of longstanding groin pain: a prospective clinical cohort study. Br J Sports Med. 2008 Oct;42(10):851-4. doi: 10.1136/bjsm.2007.039685. Epub 2008 Apr 1.

    PMID: 18381826BACKGROUND
  • Holmich P, Thorborg K, Dehlendorff C, Krogsgaard K, Gluud C. Incidence and clinical presentation of groin injuries in sub-elite male soccer. Br J Sports Med. 2014 Aug;48(16):1245-50. doi: 10.1136/bjsports-2013-092627. Epub 2013 Aug 16.

    PMID: 23956334BACKGROUND
  • Holmich P. Long-standing groin pain in sportspeople falls into three primary patterns, a "clinical entity" approach: a prospective study of 207 patients. Br J Sports Med. 2007 Apr;41(4):247-52; discussion 252. doi: 10.1136/bjsm.2006.033373. Epub 2007 Jan 29.

    PMID: 17261557BACKGROUND
  • Holmich P, Uhrskou P, Ulnits L, Kanstrup IL, Nielsen MB, Bjerg AM, Krogsgaard K. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet. 1999 Feb 6;353(9151):439-43. doi: 10.1016/S0140-6736(98)03340-6.

    PMID: 9989713BACKGROUND
  • Jardi J, Rodas G, Pedret C, Til L, Cusi M, Malliaropoulos N, Del Buono A, Maffulli N. Osteitis pubis: can early return to elite competition be contemplated? Transl Med UniSa. 2014 Apr 8;10:52-8. eCollection 2014 Sep.

    PMID: 25147768BACKGROUND
  • Lovell G. The diagnosis of chronic groin pain in athletes: a review of 189 cases. Aust J Sci Med Sport. 1995 Sep;27(3):76-9.

    PMID: 8599748BACKGROUND
  • Murphy JC, O'Malley E, Gissane C, Blake C. Incidence of injury in Gaelic football: a 4-year prospective study. Am J Sports Med. 2012 Sep;40(9):2113-20. doi: 10.1177/0363546512455315. Epub 2012 Aug 9.

    PMID: 22879401BACKGROUND
  • Renstrom P, Peterson L. Groin injuries in athletes. Br J Sports Med. 1980 Mar;14(1):30-6. doi: 10.1136/bjsm.14.1.30. No abstract available.

    PMID: 7378668BACKGROUND
  • Robinson P, Barron DA, Parsons W, Grainger AJ, Schilders EM, O'Connor PJ. Adductor-related groin pain in athletes: correlation of MR imaging with clinical findings. Skeletal Radiol. 2004 Aug;33(8):451-7. doi: 10.1007/s00256-004-0753-2. Epub 2004 Jun 29.

    PMID: 15224172BACKGROUND
  • 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, Branci S, Stensbirk F, Jensen J, Holmich P. Copenhagen hip and groin outcome score (HAGOS) in male soccer: reference values for hip and groin injury-free players. Br J Sports Med. 2014 Apr;48(7):557-9. doi: 10.1136/bjsports-2013-092607. Epub 2013 Jul 12.

    PMID: 23850734BACKGROUND
  • Thorborg K, Bandholm T, Schick M, Jensen J, Holmich P. Hip strength assessment using handheld dynamometry is subject to intertester bias when testers are of different sex and strength. Scand J Med Sci Sports. 2013 Aug;23(4):487-93. doi: 10.1111/j.1600-0838.2011.01405.x. Epub 2011 Oct 28.

    PMID: 22092308BACKGROUND
  • Walden M, Hagglund M, Ekstrand J. Football injuries during European Championships 2004-2005. Knee Surg Sports Traumatol Arthrosc. 2007 Sep;15(9):1155-62. doi: 10.1007/s00167-007-0290-3. Epub 2007 Mar 21.

    PMID: 17375283BACKGROUND
  • Franklyn-Miller A, Richter C, King E, Gore S, Moran K, Strike S, Falvey EC. Athletic groin pain (part 2): a prospective cohort study on the biomechanical evaluation of change of direction identifies three clusters of movement patterns. Br J Sports Med. 2017 Mar;51(5):460-468. doi: 10.1136/bjsports-2016-096050. Epub 2016 Oct 6.

  • Falvey EC, King E, Kinsella S, Franklyn-Miller A. Athletic groin pain (part 1): a prospective anatomical diagnosis of 382 patients--clinical findings, MRI findings and patient-reported outcome measures at baseline. Br J Sports Med. 2016 Apr;50(7):423-30. doi: 10.1136/bjsports-2015-094912. Epub 2015 Nov 30.

MeSH Terms

Conditions

Athletic InjuriesBronchiolitis Obliterans SyndromeDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andy D Franklyn-Miller, MBBS

    Sports Surgery Clinic

    STUDY DIRECTOR
  • Éanna C Falvey, MB, BCh, PhD

    Sports Surgery Clinic

    STUDY DIRECTOR
  • Enda A King, BSc, MSc

    Sports Surgery Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 8, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2022

Study Completion

December 1, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations