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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000043875
Receipt No. R000050089
Scientific Title Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/09

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Basic information
Public title Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Acronym Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Scientific Title Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Scientific Title:Acronym Is adding education to stabilization training better than stabilization training alone in patellofemoral pain patients? a randomized clinical trial
Region
Asia(except Japan)

Condition
Condition at baseline, post-intervention and 3 month follow-up
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to confirm the PE interventions effect and its combination with therapeutic exercise, the authors believed it was imperative to conduct a randomized clinical trial where education plus stabilization training (knee- hip- and trunk-focused exercise) was compared with ST alone in PFP patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain
Key secondary outcomes function, pain catastrophizing, kinesiophobia, and muscle strength

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 education plus stabilization training (ST) (knee- hip- and trunk-focused exercise)
Interventions/Control_2 ST alone
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
14 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria Persian-native male and female, aged between 18 and 40 years, primary complaint of the anterior knee and the symptoms of PFP, anterior knee pain of 3 or greater on the 10-cm visual analogue scale (VAS) for a minimum of 8 weeks before participation, anterior knee pain when performing at least two of the following activities: prolonged sitting, squatting, kneeling, running, climbing and descending stairs
Key exclusion criteria surgery and /or intra-articular pathology in any lower limb joint, patellar instability, knee joint effusion, Osgood-Schlatter or SindingLarsen-Johansson syndrome, referred pain coming from the lumbar spine, hips, ankles, or feet, and having physiotherapy treatment for PFP up to 3 months before participating
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Pouya
Middle name
Last name Rabiei
Organization Kharazmi university
Division name Sport medicine
Zip code 6664743
Address tehran
TEL 00989195394692
Email pouya.rabiei.pr@gmail.com

Public contact
Name of contact person
1st name amir
Middle name
Last name letafatkar
Organization Kharazmi University
Division name sport medicine
Zip code 6664743
Address tehran
TEL 00989357465993
Homepage URL
Email letafatkaramir@yahoo.com

Sponsor
Institute Kharazmi university
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization kharazmi university
Address teran-mofateh
Tel 00982122258084
Email ha.123466@yahoo.com

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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 01 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 60
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 Terminated
Date of protocol fixation
2020 Year 05 Month 05 Day
Date of IRB
2020 Year 05 Month 20 Day
Anticipated trial start date
2020 Year 06 Month 30 Day
Last follow-up date
2021 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 09 Day
Last modified on
2021 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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