Groin PainNCT02437942
Anatomical, Radiological and Biomechanical Examination of Athletic Groin Pain Patients and Physical Therapy Intervention
A study testing Biomechanics led physical therapy rehabilitation in people with Groin Pain, run by Sports Surgery Clinic, Santry, Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Groin Pain
- What is being tested?
- Biomechanics led physical therapy rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2015to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of athletic groin pain
- Professional athlete in full time training with groin pain diagnosis
Who cannot join
- Post infective osteitis
- Bone tumour
- Acute injury
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- Describe clinical presentation (physical examination and magnetic resonance imaging findings) for a group of athletes presenting with AGP
- To describe the different biomechanical diagnoses that exist in AGP patients
- 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.
Read the detailed description
Detailed Protocol
The following assessments will be undertaken by a consultant sports physician during the initial clinical examination:
- Hip joint range of motion (flexion, internal and external rotation)
- Flexion ADduction Internal Rotation (FADIR) and Flexion ABduction External Rotation (FABER) tests
- Squeeze tests (resisted adduction) at 90, 45 and 0 degrees were performed (SQ90°, SQ45° and SQ0° respectively)
- Resisted sit up
- Prone internal and external rotation
- Gaenslen's test
- Hip extension
- Femoral slump
- Thomas test
- Palpation of the adductor insertion to tubercle, pubic symphysis and superficial ring with resisted oblique sit up and deep ring scrotal invagination
- The crossover test Radiological examination will include magnetic resonance imaging of …..
Biomechanical testing involves the following progressive neuromuscular challenge tests which are undertaken after the clinical examination:
- Countermovement jump - Vertical jump as high as possible
- Single leg drop landing - Hop from a 30cm height onto one leg and hold the landing for 2sec
- Hurdle hop - Lateral hop over a 15cm hurdle followed by a hop back to the starting position and a hold for 2sec
- Change of direction cut - Sprint for 5 metres, make a 75 degree acute change of direction and sprint for a further five meters to the finish
- Indecision cut - Sprint for three meters then react to a light stimulus and make a 90 degree cut to the left or right for a further 1.5metres
Questionnaires
- Hip and groin outcome score (HAGOS)
- Marx activity rating scale
Physical therapy assessment:
- Single leg squat
- Straight leg raise
- Hip strength testing
- Hip range of motion
- Squeeze test
- Crossover test
- Linear running analysis
Rehabilitation Details
Movement Control Focusing on the deficits in large compound movement patterns evident during assessment as well as hip and trunk control deficits. High emphasis placed on the technical quality with which the sessions were carried out. Particular focus on pelvic control while improving sagittal and frontal plane hip and lumbopelvic control. Any symptoms during exercises indicates poor technique and the exercise will be reviewed and intensity reduced until appropriate technique achieved. The rep and set ranges reflected the emphasis on control while improving range at the thoracic spine, hip and ankle.
Strength-Power Double leg and single leg strength training carried out as necessary. Good form instructed throughout to ensure appropriate hip strategy especially under high load. Power work included single leg plyometric exercises to reduced ground contact and improve stiffness throughout the kinetic chain.
Linear Running Linear running drills focused on optimizing lumbo pelvic control in all three planes identified during assessment. Commence with wall drills and marching and skipping and progressing onto sled and harness drills which facilitate developing optimal posture with increased rate of force development and ground reaction forces to improve performance.
Multi Directional Multidirectional drills will be used to provide a neuromuscular challenge to the trunk on pelvis and hip control as well as optimizing foot position and the ability to control the centre of mass relative to the stance leg to reduce hip and pelvic overload and optimise cutting performance. Higher intensity cutting drills will be included as a progression once a painfree squeeze at 90 degrees has been achieved and symmetrical hip internal rotation bilaterally.
Conditioning With a view to ensuring all aspects of the athletes performance are addressed, conditioning will be carried out on a stationary bike to allow sufficient intensity without overloading the pubic/groin region. Sessions will be prescribed from Maximal Aerobic Power assessment on a wattbike and focused on alternate maximal and supramaximal sessions.
Hip and Groin Outcome Score (HAGOS) and MARX activity rating scale A HAGOS and MARX questionnaire will be completed by each groin patient on every visit -approximately every two weeks.
Patient Registry
Patient data will be inputted into iMedDoc medical data management software. Captured data will include:
Patient information - doubly de-identified patient code, electronic scan of consent form, anthropometric data, sport, playing position and playing level, time with pain, pain side or bilateral pain.
Sports medicine consultants findings - Diagnosis, magnetic resonance imaging findings, findings of clinical examination Physiotherapist's findings - clinical examination findings for initial test and post-rehabilitation HAGOS - hip and groin outcome score for initial test and throughout rehabilitation MARX activity rating scale - for initial test and throughout rehabilitation Magnetic resonance image files Quality assurance plan Weekly cross-checking will be undertaken by two members of staff to ensure data entered onto the registry is correct as per paper records and per acceptable ranges.
A six-monthly audit of the registry will be undertaken by external auditors (Dr Kieran Moran, Dublin City University and Dr Siobhan Strike, Roehampton University).
Registry standard operating procedures
Basic patient contact details are inputted by administration staff Patient consent form is uploaded to imeddoc software Doctors and physiotherapists input physical examination findings on imeddoc software HAGOS and Marx activity questionnaire are inputted by the patient using a tablet device. This data is uploaded to imeddoc automatically once questionnaire is completed.
Data is downloaded from imeddoc and placed into Microsoft excel. Patient name is de-identified.
Two researchers manage the registry updates and cross-check the data on a weekly basis. Where applicable paper records are checked to ensure the information submitted to the registry is complete and is within acceptable ranges.
A six-monthly audit of the registry will be undertaken by external auditors (Dr Kieran Moran, Dublin City University, Ireland and Dr Siobhan Strike, University of Roehampton, London).
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect Suggested sample size = 600 Biomechanical clustering techniques (which will be used to describe the different biomechanical diagnoses that exist in AGP patients) require relatively large numbers of participants. Previous studies have utilised an n = 588 for this purpose (Sutherland and Davids), therefore it is hypothesised that 600 will be sufficient for such an analysis in the current study.
A sample size of n = 600 will allow a comprehensive examination of the clinical presentation of groin pain. Previous studies have only utilised up to 218 participants (Bradshaw et al 2008).
Finally, a sample size of 600 will be sufficient to account for drop out from the rehabilitation intervention. Drop out may be relatively high due to the regular physical therapy contact required (approximately every 2 weeks) despite the wide geographical spread of participants (throughout Ireland).
Registry Data Dictionary
Term Definition Rt Right Lt Left Dx Ant Plate Diagnosis of anterior plate pathology as a source of the groin pain Dx Hip Diagnosis of hip pathology as a source of the groin pain Dx Inguinal Diagnosis of inguinal ligament pathology as a source of the groin pain Dx Hip Flex Diagnosis of hip flexor pathology as a source of the groin pain Dx Labral Tear Diagnosis of hip labral tear pathology as a source of the groin pain Dx Apon Tear Diagnosis of pubic aponeurosis pathology as a source of the groin pain MRI BMO UNI Presence of bony oedema on magnetic resonance image - one side only MRI BMO BL Presence of bony oedema on magnetic resonance image - both sides MRI Rec Abd Ins Magnetic resonance image signal in the rectus abdominals insertion MRI Add Ins Magnetic resonance image signal in the adductor insertion MRI CAM Magnetic resonance image finding of a CAM hip impingement MRI FAI Magnetic resonance image finding of a femeroacetabular impingement MRI Apon Tear Magnetic resonance image finding of a aponeurosis tear Reduced Hip Flex Reduced hip flexion range of motion Reduced Hip IR Reduced hip internal range of motion Reduced Hip ER Reduced hip external range of motion FADIR Flexion, adduction and internal rotation symptomatic FABER Flexion, abduction and internal rotation symptomatic Squeeze 90 Squeeze test at 90 degrees is symptomatic Squeeze 45 Squeeze test at 45 degrees is symptomatic Squeeze 0 Straight leg squeeze test is symptomatic Thomas Thomas test symptomatic Mod Thom Modified Thomas test is symptomatic Res Leg Lift Resisted leg lift is symptomatic Adduct Tub Adductor tubercle is symptomatic on palpation Res Rot Resisted hip rotation is symptomatic Superf Inguin Ring Superficial inguinal ring symptomatic on palpation Rec Abd Insert Rectus abdominals insertion is symptomatic on palpation Deep Ring Deep inguinal ring is symptomatic on palpation Pubic Symp Pubic symphysis is symptomatic on palpation Slump Slump test positive SIJ Shear Sacro iliac joint shear is symptomatic Prone In/Et Rot Pronated internal/external hip rotation range of motion Femoral Slump Femoral slump test is positive Obs Lx Spine Observation of lumbar spine SL Squat Movement control in a single squat SL Bridge Lt Movement control in a single leg bridge Funct ASLR RT Functional active straight leg raise right Funct ASLR Lt Functional active straight leg raise right Res Hip Fle Resisted hip flexion strength test Hip Flex Hip flexion range of motion Hip IR Hip internal rotation range of motion Hip ER Hip external range of motion Prone IR Pronated hip internal rotation Short Hip FLex Short hip flexor range of motion Long Hip Flex Long hip flexor range of motion ASLR Active straight leg raise Crossover +ve Crossover test symptomatic Crossover -ve Crossover test non-symptomatic HAGOS Pain Pain score from the HAGOS questionnaire HAGOS Symptom Symptoms score from the HAGOS questionnaire HAGOS ADL Activities of daily living score from the HAGOS questionnaire HAGOS SportRec Sport and Recreation score from the HAGOS questionnaire HAGOS PA Physical activity score from the HAGOS questionnaire HAGOS QOL Quality of life score from the HAGOS questionnaire
Plan for missing data
Physical therapist completes a checklist once per week to flag missing data. This data is then completed from paper records.
Statistical analysis plan
Primary outcome measure (HAGOS) - Chi square test to examine changes in repeat HAGOS Secondary outcome measures (Kinetics and kinematics) - Repeated measures ANOVA to examine post-training changes in biomechanical variables Other outcome measures (Physical therapy measures) - Repeated measures ANOVA to examine post-training changes in physiotherapist measures
- Conditions
- Groin Pain
- Being tested
- Biomechanics led physical therapy rehabilitation
- Keywords
- Athletic injuries, chronic, rehabilitation, diagnosis, biomechanics
- Medical subject headings
- Athletic Injuries, Bronchiolitis Obliterans Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanics led physical therapy rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Biomechanics led physical therapy rehabilitation | Experimental | Physical therapy exercise rehabilitation Receives: Other: Biomechanics led physical therapy rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The post-training change in biomechanical measures following the intervention
Measured: Following rehabilitation, an expected average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2022
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Groin PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sports Surgery Clinic, Santry, Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Insight Centre for Data Analytics, Science Foundation Ireland
- Responsible party
- Sponsor
- Investigators
- Andy D Franklyn-Miller, MBBS, Study director, Sports Surgery ClinicÉanna C Falvey, MB, BCh, PhD, Study director, Sports Surgery ClinicEnda A King, BSc, MSc, Principal investigator, Sports Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437942
- Sponsor's protocol ID
- SSC-Groin-001
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2015
- Last updated
- 22 Apr 2024
- Results posted
- No
Publications
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.
PubMed 18381826Holmich 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.
PubMed 23956334Holmich 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.
PubMed 17261557Holmich 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.
PubMed 9989713Jardi 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.
PubMed 25147768Lovell 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.
PubMed 8599748Murphy 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.
PubMed 22879401Renstrom 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.
PubMed 7378668Robinson 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.
PubMed 15224172Serner 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.
PubMed 25633830Thorborg 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.
PubMed 23850734Thorborg 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.
PubMed 22092308Walden 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.
PubMed 17375283Franklyn-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.
PubMed 28209597Falvey 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.
PubMed 26626272
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02437942
- Acronym / sponsor ID
- SSC-Groin-001
- Conditions
- Groin Pain
- Keywords
- Athletic injuries, chronic, rehabilitation, diagnosis, biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Sports Surgery Clinic, Santry, DublinUniversity, hospital or other
- Collaborators
- Insight Centre for Data Analytics, Science Foundation Ireland
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Describe clinical presentation (physical examination and magnetic resonance imaging findings) for a group of athletes presenting with AGP
- To describe the different biomechanical diagnoses that exist in AGP patients
- 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.
Detailed description
Detailed Protocol
The following assessments will be undertaken by a consultant sports physician during the initial clinical examination:
- Hip joint range of motion (flexion, internal and external rotation)
- Flexion ADduction Internal Rotation (FADIR) and Flexion ABduction External Rotation (FABER) tests
- Squeeze tests (resisted adduction) at 90, 45 and 0 degrees were performed (SQ90°, SQ45° and SQ0° respectively)
- Resisted sit up
- Prone internal and external rotation
- Gaenslen's test
- Hip extension
- Femoral slump
- Thomas test
- Palpation of the adductor insertion to tubercle, pubic symphysis and superficial ring with resisted oblique sit up and deep ring scrotal invagination
- The crossover test Radiological examination will include magnetic resonance imaging of …..
Biomechanical testing involves the following progressive neuromuscular challenge tests which are undertaken after the clinical examination:
- Countermovement jump - Vertical jump as high as possible
- Single leg drop landing - Hop from a 30cm height onto one leg and hold the landing for 2sec
- Hurdle hop - Lateral hop over a 15cm hurdle followed by a hop back to the starting position and a hold for 2sec
- Change of direction cut - Sprint for 5 metres, make a 75 degree acute change of direction and sprint for a further five meters to the finish
- Indecision cut - Sprint for three meters then react to a light stimulus and make a 90 degree cut to the left or right for a further 1.5metres
Questionnaires
- Hip and groin outcome score (HAGOS)
- Marx activity rating scale
Physical therapy assessment:
- Single leg squat
- Straight leg raise
- Hip strength testing
- Hip range of motion
- Squeeze test
- Crossover test
- Linear running analysis
Rehabilitation Details
Movement Control Focusing on the deficits in large compound movement patterns evident during assessment as well as hip and trunk control deficits. High emphasis placed on the technical quality with which the sessions were carried out. Particular focus on pelvic control while improving sagittal and frontal plane hip and lumbopelvic control. Any symptoms during exercises indicates poor technique and the exercise will be reviewed and intensity reduced until appropriate technique achieved. The rep and set ranges reflected the emphasis on control while improving range at the thoracic spine, hip and ankle.
Strength-Power Double leg and single leg strength training carried out as necessary. Good form instructed throughout to ensure appropriate hip strategy especially under high load. Power work included single leg plyometric exercises to reduced ground contact and improve stiffness throughout the kinetic chain.
Linear Running Linear running drills focused on optimizing lumbo pelvic control in all three planes identified during assessment. Commence with wall drills and marching and skipping and progressing onto sled and harness drills which facilitate developing optimal posture with increased rate of force development and ground reaction forces to improve performance.
Multi Directional Multidirectional drills will be used to provide a neuromuscular challenge to the trunk on pelvis and hip control as well as optimizing foot position and the ability to control the centre of mass relative to the stance leg to reduce hip and pelvic overload and optimise cutting performance. Higher intensity cutting drills will be included as a progression once a painfree squeeze at 90 degrees has been achieved and symmetrical hip internal rotation bilaterally.
Conditioning With a view to ensuring all aspects of the athletes performance are addressed, conditioning will be carried out on a stationary bike to allow sufficient intensity without overloading the pubic/groin region. Sessions will be prescribed from Maximal Aerobic Power assessment on a wattbike and focused on alternate maximal and supramaximal sessions.
Hip and Groin Outcome Score (HAGOS) and MARX activity rating scale A HAGOS and MARX questionnaire will be completed by each groin patient on every visit -approximately every two weeks.
Patient Registry
Patient data will be inputted into iMedDoc medical data management software. Captured data will include:
Patient information - doubly de-identified patient code, electronic scan of consent form, anthropometric data, sport, playing position and playing level, time with pain, pain side or bilateral pain.
Sports medicine consultants findings - Diagnosis, magnetic resonance imaging findings, findings of clinical examination Physiotherapist's findings - clinical examination findings for initial test and post-rehabilitation HAGOS - hip and groin outcome score for initial test and throughout rehabilitation MARX activity rating scale - for initial test and throughout rehabilitation Magnetic resonance image files Quality assurance plan Weekly cross-checking will be undertaken by two members of staff to ensure data entered onto the registry is correct as per paper records and per acceptable ranges.
A six-monthly audit of the registry will be undertaken by external auditors (Dr Kieran Moran, Dublin City University and Dr Siobhan Strike, Roehampton University).
Registry standard operating procedures
Basic patient contact details are inputted by administration staff Patient consent form is uploaded to imeddoc software Doctors and physiotherapists input physical examination findings on imeddoc software HAGOS and Marx activity questionnaire are inputted by the patient using a tablet device. This data is uploaded to imeddoc automatically once questionnaire is completed.
Data is downloaded from imeddoc and placed into Microsoft excel. Patient name is de-identified.
Two researchers manage the registry updates and cross-check the data on a weekly basis. Where applicable paper records are checked to ensure the information submitted to the registry is complete and is within acceptable ranges.
A six-monthly audit of the registry will be undertaken by external auditors (Dr Kieran Moran, Dublin City University, Ireland and Dr Siobhan Strike, University of Roehampton, London).
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect Suggested sample size = 600 Biomechanical clustering techniques (which will be used to describe the different biomechanical diagnoses that exist in AGP patients) require relatively large numbers of participants. Previous studies have utilised an n = 588 for this purpose (Sutherland and Davids), therefore it is hypothesised that 600 will be sufficient for such an analysis in the current study.
A sample size of n = 600 will allow a comprehensive examination of the clinical presentation of groin pain. Previous studies have only utilised up to 218 participants (Bradshaw et al 2008).
Finally, a sample size of 600 will be sufficient to account for drop out from the rehabilitation intervention. Drop out may be relatively high due to the regular physical therapy contact required (approximately every 2 weeks) despite the wide geographical spread of participants (throughout Ireland).
Registry Data Dictionary
Term Definition Rt Right Lt Left Dx Ant Plate Diagnosis of anterior plate pathology as a source of the groin pain Dx Hip Diagnosis of hip pathology as a source of the groin pain Dx Inguinal Diagnosis of inguinal ligament pathology as a source of the groin pain Dx Hip Flex Diagnosis of hip flexor pathology as a source of the groin pain Dx Labral Tear Diagnosis of hip labral tear pathology as a source of the groin pain Dx Apon Tear Diagnosis of pubic aponeurosis pathology as a source of the groin pain MRI BMO UNI Presence of bony oedema on magnetic resonance image - one side only MRI BMO BL Presence of bony oedema on magnetic resonance image - both sides MRI Rec Abd Ins Magnetic resonance image signal in the rectus abdominals insertion MRI Add Ins Magnetic resonance image signal in the adductor insertion MRI CAM Magnetic resonance image finding of a CAM hip impingement MRI FAI Magnetic resonance image finding of a femeroacetabular impingement MRI Apon Tear Magnetic resonance image finding of a aponeurosis tear Reduced Hip Flex Reduced hip flexion range of motion Reduced Hip IR Reduced hip internal range of motion Reduced Hip ER Reduced hip external range of motion FADIR Flexion, adduction and internal rotation symptomatic FABER Flexion, abduction and internal rotation symptomatic Squeeze 90 Squeeze test at 90 degrees is symptomatic Squeeze 45 Squeeze test at 45 degrees is symptomatic Squeeze 0 Straight leg squeeze test is symptomatic Thomas Thomas test symptomatic Mod Thom Modified Thomas test is symptomatic Res Leg Lift Resisted leg lift is symptomatic Adduct Tub Adductor tubercle is symptomatic on palpation Res Rot Resisted hip rotation is symptomatic Superf Inguin Ring Superficial inguinal ring symptomatic on palpation Rec Abd Insert Rectus abdominals insertion is symptomatic on palpation Deep Ring Deep inguinal ring is symptomatic on palpation Pubic Symp Pubic symphysis is symptomatic on palpation Slump Slump test positive SIJ Shear Sacro iliac joint shear is symptomatic Prone In/Et Rot Pronated internal/external hip rotation range of motion Femoral Slump Femoral slump test is positive Obs Lx Spine Observation of lumbar spine SL Squat Movement control in a single squat SL Bridge Lt Movement control in a single leg bridge Funct ASLR RT Functional active straight leg raise right Funct ASLR Lt Functional active straight leg raise right Res Hip Fle Resisted hip flexion strength test Hip Flex Hip flexion range of motion Hip IR Hip internal rotation range of motion Hip ER Hip external range of motion Prone IR Pronated hip internal rotation Short Hip FLex Short hip flexor range of motion Long Hip Flex Long hip flexor range of motion ASLR Active straight leg raise Crossover +ve Crossover test symptomatic Crossover -ve Crossover test non-symptomatic HAGOS Pain Pain score from the HAGOS questionnaire HAGOS Symptom Symptoms score from the HAGOS questionnaire HAGOS ADL Activities of daily living score from the HAGOS questionnaire HAGOS SportRec Sport and Recreation score from the HAGOS questionnaire HAGOS PA Physical activity score from the HAGOS questionnaire HAGOS QOL Quality of life score from the HAGOS questionnaire
Plan for missing data
Physical therapist completes a checklist once per week to flag missing data. This data is then completed from paper records.
Statistical analysis plan
Primary outcome measure (HAGOS) - Chi square test to examine changes in repeat HAGOS Secondary outcome measures (Kinetics and kinematics) - Repeated measures ANOVA to examine post-training changes in biomechanical variables Other outcome measures (Physical therapy measures) - Repeated measures ANOVA to examine post-training changes in physiotherapist measures
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomechanics led physical therapy rehabilitation | Experimental | Other: Biomechanics led physical therapy rehabilitationPhysical therapy exercise rehabilitation |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of athletic groin pain
- Professional athlete in full time training with groin pain diagnosis
Key exclusion criteria (3 listed)
- Post infective osteitis
- Bone tumour
- Acute injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomechanics led physical therapy rehabilitationRehabilitation 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. | Other | Biomechanics led physical therapy rehabilitation |
Primary outcome
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.
1 secondary outcome
Kinetic and kinematic composite score
Time frame: Following rehabilitation, an expected average of 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 18381826Bradshaw 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.
- Background: PubMed 23956334Holmich 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.
- Background: PubMed 17261557Holmich 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.
- Background: PubMed 9989713Holmich 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.
- Background: PubMed 25147768Jardi 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.
- Background: PubMed 8599748Lovell 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.
- Background: PubMed 22879401Murphy 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.
- Background: PubMed 7378668Renstrom 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.
- Background: PubMed 15224172Robinson 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.
- Background: PubMed 25633830Serner 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.
- Background: PubMed 23850734Thorborg 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.
- Background: PubMed 22092308Thorborg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy D Franklyn-Miller, MBBS study director
Sports Surgery Clinic
Éanna C Falvey, MB, BCh, PhD study director
Sports Surgery Clinic
Enda A King, BSc, MSc principal investigator
Sports Surgery Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomechanics led physical therapy rehabilitation in people with Groin Pain, run by Sports Surgery Clinic, Santry, Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02437942, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.