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ISRCTN
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ISRCTN83938749
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ClinicalTrials.gov identifier
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Public title
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Exercise therapy for patello-femoral pain syndrome (PFPS): a randomised clinical trial in general practice and sports medicine
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Scientific title
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Acronym
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PEX-study
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Serial number at source
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945-04-356
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Study hypothesis
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1. What is the effectiveness of advice and information by the physician in combination with supervised exercise therapy in patients with PFPS in general practice and sports clinics compared to advice and information by the physician only?
2. What is the cost-effectiveness of advice and information by the physician in combination with supervised exercise therapy in patients with PFPS in general practice and sports clinics compared to advice and information by the physician only?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Patello-femoral pain syndrome
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Participants - inclusion criteria
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Patients with patello-femoral pain syndrome aged 15-40 years
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Participants - exclusion criteria
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1. Prior exercise therapy
2. Other knee problems (trauma, surgery, etc.)
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Anticipated start date
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01/04/2005
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Anticipated end date
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03/06/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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136
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Interventions
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6 + 6 weeks exercise therapy (standardised) with initial supervison of physical therapist plus advice and information by the physician versus advice and information by the physician only
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Primary outcome measure(s)
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1. Level of pain
2. Knee function
3. Subjective improvement
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Secondary outcome measure(s)
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Cost-utility (economical evaluation)
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Sources of funding
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Netherlands Organisation for Health Research and Development (ZonMw) project number 945-04-356
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Trial website
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Publications
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1. 2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16545120
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19843565
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Contact name
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Dr
Sita
Bierma-Zeinstra
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Address
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Erasmus MC - University Medical Center Rotterdam
Dr Molewaterplein 50
Kamer FF 320
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City/town
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Rotterdam
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Zip/Postcode
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3015 GE
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Country
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Netherlands
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Sponsor
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Netherlands Organisation for Health Research and Development (ZonMw)
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Address
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Postbus 93245
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City/town
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Den Haag
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Sponsor website:
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http://www.zonmw.nl
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Date applied
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16/07/2005
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Last edited
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26/10/2009
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Date ISRCTN assigned
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21/10/2005
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