Condition category
Musculoskeletal Diseases
Date applied
16/07/2005
Date assigned
21/10/2005
Last edited
26/10/2009
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 Sita Bierma-Zeinstra

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

945-04-356

Study information

Scientific title

Acronym

PEX-study

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Level of pain
2. Knee function
3. Subjective improvement

Secondary outcome measures

Cost-utility (economical evaluation)

Overall trial start date

01/04/2005

Overall trial end date

03/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with patello-femoral pain syndrome aged 15-40 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

136

Participant exclusion criteria

1. Prior exercise therapy
2. Other knee problems (trauma, surgery, etc.)

Recruitment start date

01/04/2005

Recruitment end date

03/06/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC - University Medical Center Rotterdam
Rotterdam
3015 GE
Netherlands

Sponsor information

Organisation

Netherlands Organisation for Health Research and Development (ZonMw)

Sponsor details

Postbus 93245
Den Haag
2509 AE
Netherlands

Sponsor type

Research organisation

Website

http://www.zonmw.nl

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) project number 945-04-356

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16545120
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19843565

Publication citations

  1. Protocol

    van Linschoten R, van Middelkoop M, Berger MY, Heintjes EM, Koopmanschap MA, Verhaar JA, Koes BW, Bierma-Zeinstra SM, The PEX study - Exercise therapy for patellofemoral pain syndrome: design of a randomized clinical trial in general practice and sports medicine [ISRCTN83938749]., BMC Musculoskelet Disord, 2006, 7, 31, doi: 10.1186/1471-2474-7-31.

  2. Results

    van Linschoten R, van Middelkoop M, Berger MY, Heintjes EM, Verhaar JA, Willemsen SP, Koes BW, Bierma-Zeinstra SM, Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial., BMJ, 2009, 339, b4074.

Additional files

Editorial Notes