UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Targeted Intervention in Patellofemoral Pain Syndrome
Title of the study (Brief title)	Targeted treatment in patient with patellofemoral pain
Region	Europe

Condition
Condition	patellofemoral pain
Classification by specialty	Medicine in general Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the success of the targeted therapies designed according to the characteristics of the sub-group in patients that current applied multi-model treatment failed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Alterations in Pain and functional capabilities after targeted intervention patient with patellofemoral pain syndrome
Key secondary outcomes	Alterations in lower extremity stifness, strength, biomechanical parameters after treatment

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom Other
Interventions/Control_1	Clinic based knee exercises and/or electrotherapy modalities 3 times per week, duration: 6 weeks
Interventions/Control_2	Specific exercises and/or foot orthoses and /or knee orthoses application, 3 times per week, duration: 6 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Anterior knee pain during at least two following activities; prolonged sitting, climbing stairs, squatting,running, hopping, kneeling 2) Pain during at least two of the followings: manuel compression, palpation of the posterolateral and posteromedial borders of the patella, resistive knee extension
Key exclusion criteria	previous knee surgery clinical evidence of ligamentous instability, a history of patellar subluxation or dislocation, joint effusion, locking and/or giving way, bursitis, tendinopathy, Osgood Schlatters disease, Sinding-Larsen Johansson Syndrome, muscle tears or symptomatic knee plicae, serious co-morbidity which would preclude or affect compliance with the assessment, pregnancy.
Target sample size	20

Research contact person
Name of lead principal investigator	Hayri Baran Yosmaoglu
Organization	Baskent University
Division name	Faculty of Health Science/Department of Physiotherapy
Address	Ankara/Turkey
TEL	+903122466673
Email	baran79@gmail.com

Public contact
Name of contact person	Hayri Baran Yosmaoglu
Organization	Baskent University
Division name	Faculty of Health Science/Department of Physiotherapy
Address	Ankara/ Turkey
TEL	+903122466673
Homepage URL
Email	baran79@gmail.com

Sponsor
Institute	BASKENT UNIVERSITY
Institute
Department

Funding Source
Organization	THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TURKEY
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	TURKEY

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Baskent University Hospital (ANKARA/TURKEY)

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 11 Day
Anticipated trial start date	2017 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 18 Day
Last modified on	2019 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032886