Longlasting adduction-related groin injuries in athletes; regular care or a novel treatment approach

ISRCTN	ISRCTN65462262
DOI	https://doi.org/10.1186/ISRCTN65462262
Protocol serial number	7502.0005
Sponsor	University Medical Center Utrecht (UMCU) (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw)

Submission date: 19/07/2006
Registration date: 19/07/2006
Last edited: 19/07/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr F. J. G. Backx
Scientific

Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Phone	+31 (0)30 2501583
Email	fbackx@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LIES
Study objectives	Athletes with longstanding groin pain recover faster and more completely if they are treated with specific pelvic stabilizing muscle training compared with regular care.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Groin pain
Intervention	Two different kinds of physiotherapeutic treatments are given for the population. Both treatment strategies are already in use in daily practice. Patients are randomised to receive either pelvic-stabilizing muscle training or usual care
Intervention type	Other
Primary outcome measure(s)	1. Severity of the pain over the last three days (11-point visual analogue scale [VAS]) 2. Participation in sports (11-point VAS-scale) 3. General disability (adapted Quebec low back pain disability scale) 4. Global change (six-point Likert scale) 5. How long before return to full athletic activity 6. Recurrences of the same complaints Parameters 1, 2, 3 are measured before and directly after the period of treatment and 26 and 52 weeks after the start of treatment. Parameters 4, 5 and 6 are only measured at 26 and 52 weeks after treatment.
Key secondary outcome measure(s)	1. Hip adduction strength (hand-held dynamometer); 2. Contraction pattern of the abdominal musculature (ultrasound echografie); 3. Active straight leg raise test (ASLR).
Completion date	15/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Male
Target sample size at registration	80
Key inclusion criteria	Male athletes, 18-45 years old, hip adduction-related complaints, for a period of at least six weeks, strong desire to compete in sports.
Key exclusion criteria	1. Pain as a result of high-impact trauma, suspicion of fracture, rupture of labrum of the hip, hip arthrosis or arthritis, femoral or inguinal hernia, radicular symptoms, infection of the urinary tract, bursitis, vessel disease, abnormal anatomy 2. Treated for the same (episode of) complaints previously, treated for low back pain with an exercise program in the previous six months, systemic diseases 3. Psychopathology 4. Physical handicaps that make it impossible for the subject to take part of the study
Date of first enrolment	01/03/2005
Date of final enrolment	15/08/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Heidelberglaan 100

Utrecht
3584 CX
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan