Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anatomical, Radiological and Biomechanical Examination of Athletic Groin Pain Patients and Physical Therapy Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02437942
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Insight Centre for Data Analytics
Science Foundation Ireland
Information provided by (Responsible Party):
Sports Surgery Clinic, Santry, Dublin

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

It is hypothesised that standardised magnetic resonance imaging will aid in the anatomical diagnosis of athletic groin pain patients. From a biomechanics perspective, distinct subgroups/clusters will exist that differ from each other in how they undertake dynamic sport specific actions. These distinct clusters will describe potential biomechanical diagnoses that exist in groin pain patients. A biomechanics led rehabilitation program will return groin pain patients back to sport more quickly than previous rehabilitation programs without biomechanical diagnostic information.

Brief protocol Participants will be recruited from patients with chronic athletic groin pain who present for investigation and rehabilitation at Sports Surgery Clinic, Ireland. A standardised clinical examination will be undertaken including range of motion assessment, pain provocation and load tolerance tests, and palpation.

A Magnetic Resonance Image of the hip and groin region will then be undertaken and read by a consultant sports physician.

Biomechanical assessment will include capturing of jumping, hopping and cutting mechanics through the use of three dimensional motion capture technology and force plates. Here reflective markers are placed on the skin at anatomical landmarks. These markers are picked up by the cameras and tracked at 200 frames per second. Participants will contact the force plate with their foot on undertaking the movements. Force and marker data will be combined to calculate joint angles and moments.

Physical therapy assessment will include an assessment of functional movement, range of motion testing, adductor squeeze tests, strength assessment of hip and trunk. Physiotherapists will utilise three dimensional biomechanical data during cutting and landing to inform individualised rehabilitation. Rehabilitation will consist of movement control, whole body strength and power, linear running mechanics, multi-directional mechanics and conditioning sessions. Participants will have follow up physical therapy appointments approximately every two weeks. A hip and groin outcome score (HAGOS) will be used to monitor the morbidity and severity of the injury throughout the rehabilitation process.

Once the physiotherapist determines that the patient is ready to return to play a biomechanical re-test will be undertaken.


Condition or disease Intervention/treatment Phase
Groin Pain Other: Biomechanics led physical therapy rehabilitation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Examination of the Anatomical and Biomechanical Diagnoses That Exist in Athletic Groin Pain Patients and the Effects of a Biomechanics Led Rehabilitation Intervention in These Same Patients
Actual Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biomechanics led physical therapy rehabilitation
Physical therapy exercise rehabilitation
Other: Biomechanics led physical therapy rehabilitation
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.




Primary Outcome Measures :
  1. Hip and groin outcome score (HAGOS) [ Time Frame: Over the course of the rehabilitation time frame and one year and two years post initial consultation ]
    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.


Secondary Outcome Measures :
  1. Kinetic and kinematic composite score [ Time Frame: Following rehabilitation, an expected average of 10 weeks ]
    The post-training change in biomechanical measures following the intervention


Other Outcome Measures:
  1. Hip range of movement [ Time Frame: Following rehabilitation, an expected average of 10 weeks ]
    Post rehabilitation change in hip range as assessed by the physical therapist

  2. Hip strength [ Time Frame: Following rehabilitation, an expected average of 10 weeks ]
    Post rehabilitation change in hip strength as assessed by the physical therapist

  3. Squeeze test [ Time Frame: Following rehabilitation, an expected average of 10 weeks ]
    Using a pressure cuff, measure the pressure at which pain is felt

  4. Cross-over test [ Time Frame: Following rehabilitation, an expected average of 10 weeks ]
    Pain provocation test undertaken by physical therapist



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Post infective osteitis
  • Bone tumour
  • Acute injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437942


Contacts
Layout table for location contacts
Contact: Andy D Franklyn-Miller, MBBS 00 353 1 526 2030 afranklynmiller@me.com
Contact: Éanna C Falvey 00 353 1 526 2030 e.falvey@mac.com

Locations
Layout table for location information
Ireland
Sports Surgery Clinic Recruiting
Dublin, Leinster, Ireland
Contact: Andy D Franklyn-Miller, MBBS    00 353 1 526 2030    afranklynmiller@me.com   
Contact: Enda A King, BSc, MSc    00 353 1 526 2030    endaking@sportssurgeryclinic.com   
Sponsors and Collaborators
Sports Surgery Clinic, Santry, Dublin
Insight Centre for Data Analytics
Science Foundation Ireland
Investigators
Layout table for investigator information
Study Director: Andy D Franklyn-Miller, MBBS Sports Surgery Clinic
Study Director: Éanna C Falvey, MB, BCh, PhD Sports Surgery Clinic
Principal Investigator: Enda A King, BSc, MSc Sports Surgery Clinic
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sports Surgery Clinic, Santry, Dublin
ClinicalTrials.gov Identifier: NCT02437942    
Other Study ID Numbers: SSC-Groin-001
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Keywords provided by Sports Surgery Clinic, Santry, Dublin:
Athletic injuries
chronic
rehabilitation
diagnosis
biomechanics