Condition category
Signs and Symptoms
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
19/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes