Exercise therapy for patello-femoral pain syndrome (PFPS): a randomised clinical trial in general practice and sports medicine

ISRCTN	ISRCTN83938749
DOI	https://doi.org/10.1186/ISRCTN83938749
Protocol serial number	945-04-356
Sponsor	Netherlands Organisation for Health Research and Development (ZonMw)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) project number 945-04-356

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Sita Bierma-Zeinstra
Scientific

Erasmus MC - University Medical Center Rotterdam
Dr Molewaterplein 50
Kamer FF 320
Rotterdam
3015 GE
Netherlands

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PEX-study
Study objectives	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?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Patello-femoral pain syndrome
Intervention	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
Intervention type	Other
Primary outcome measure(s)	1. Level of pain 2. Knee function 3. Subjective improvement
Key secondary outcome measure(s)	Cost-utility (economical evaluation)
Completion date	03/06/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	136
Key inclusion criteria	Patients with patello-femoral pain syndrome aged 15-40 years
Key exclusion criteria	1. Prior exercise therapy 2. Other knee problems (trauma, surgery, etc.)
Date of first enrolment	01/04/2005
Date of final enrolment	03/06/2007

Erasmus MC - University Medical Center Rotterdam

Rotterdam
3015 GE
Netherlands

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/10/2009		Yes	No
Protocol article	protocol	17/03/2006		Yes	No