UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058100 |
|---|---|
| Receipt number | R000066398 |
| Scientific Title | Investigating the effect of adding intervention and pain neuroscience education to hip and knee resistance training on pain, motor function, dynamic valgus kinesiophobia and catastrophizing in people with patellofemoral |
| Date of disclosure of the study information | 2025/06/05 |
| Last modified on | 2025/06/05 23:25:24 |
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Basic information
Public title
The effect of resistance training combined with feedback on knee pain and mobility in individual with patellofemoral pain
Acronym
PFP-Train
Scientific Title
Investigating the effect of adding intervention and pain neuroscience education to hip and knee resistance training on pain, motor function, dynamic valgus kinesiophobia and catastrophizing in people with patellofemoral
Scientific Title:Acronym
PFP-NeuroTrain
Region
| Asia(except Japan) |
Condition
Condition
Patellofemoral pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of study is to investigate effects of adding intervention and pain neuroscience education to resistance exersciesesfor the hip and knee muscles on pain, motor function, dynamic knee valgus, , kinesiophobia and pain catastrophizing in individual with patellofemoral pian
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain intensity will be assessed using the Visual Analoge Scale(VAS), a 10 cm horizontal line anchored by "no pain" and "worst imaginable pain".Measurements will be taken at baseline(prior to the intervention) and 8 weeks after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Control group: Resistance training only
Interventions/Control_2
Experimental group 1: Resistance training combined with pain neuroscience education and internal feedback on knee aligment
Interventions/Control_3
Experimental group 2:Resistance training combined with pain neuroscience education only(without feedback)
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
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 18-30 years with pain of 3-7 in the front of the knee for at least 3 months, with the approval of a physician
Positive Clark test
Increased pain with at least two activities
Normal body mass index
Key exclusion criteria
History of lower limb surgery or injury to the hip or knee
Heart disease or neurological disorder
Osteoarthritis and rheumatoid arthritis
Pregnancy
Other knee pathologies
Trunk and lower limb deformity
Leg length difference of more than one centimeter when lying down
Presence of active people and athletes
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Malihe |
| Middle name | Hadad |
| Last name | Nezhad |
Organization
Kharazmi University
Division name
Department of Sports injuries and corrective exercises
Zip code
15719-14911
Address
Tehran, Mirdamad Street, Hesari Street, Keshvari Sports Complex, Center for Movement Sciences, Kharazmi University
TEL
0989126469464
m.hadadnezhad@yahoo.com
Public contact
Name of contact person
| 1st name | Rokhsare |
| Middle name | Arab |
| Last name | SHybani |
Organization
Kharazmi University
Division name
Department of Sports injuries and corrective exercises
Zip code
1451793875
Address
No. 15, Mohajerani Alley, Dehghan Street, Piroozi Street
TEL
0989175318537
Homepage URL
Rokhsarearbshybani@yahoo.com
Sponsor or person
Institute
Kharazmi University
Institute
Department
Personal name
Rokhsare Arabshybani
Funding Source
Organization
Kharazmi University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Iran
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kharazmi University
Address
Tehran,Qods City (West), Simay Iran Street - Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th Floor
Tel
0982181455618
ethics@ssrc.ac.ir
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
| 2025 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
There is a plan to release the protocol, but the URL has not been determined yet
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
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
| 2024 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066398
