UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028738 |
|---|---|
| Receipt number | R000032886 |
| Scientific Title | Targeted Intervention in Patellofemoral Pain Syndrome |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2019/02/20 18:34:00 |
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Basic information
Public title
Targeted Intervention in Patellofemoral Pain Syndrome
Acronym
Targeted treatment in patient with patellofemoral pain
Scientific Title
Targeted Intervention in Patellofemoral Pain Syndrome
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hayri Baran Yosmaoglu |
Organization
Baskent University
Division name
Faculty of Health Science/Department of Physiotherapy
Zip code
Address
Ankara/Turkey
TEL
+903122466673
baran79@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayri Baran Yosmaoglu |
Organization
Baskent University
Division name
Faculty of Health Science/Department of Physiotherapy
Zip code
Address
Ankara/ Turkey
TEL
+903122466673
Homepage URL
baran79@gmail.com
Sponsor or person
Institute
BASKENT UNIVERSITY
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 11 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032886
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
