Contact information
Type
Scientific
Primary contact
Dr F. J. G. Backx
ORCID ID
Contact details
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 2501583
fbackx@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7502.0005
Study information
Scientific title
Acronym
LIES
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
1. Hip adduction strength (hand-held dynamometer);
2. Contraction pattern of the abdominal musculature (ultrasound echografie);
3. Active straight leg raise test (ASLR).
Overall trial start date
01/03/2005
Overall trial end date
15/08/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
80
Participant 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
Recruitment start date
01/03/2005
Recruitment end date
15/08/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary