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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044440
Receipt No. R000050769
Scientific Title Effect of pain neuroscience education and mind-body exercises in patients with knee osteoarthritis
Date of disclosure of the study information 2021/06/05
Last modified on 2021/06/05

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Basic information
Public title Effect of pain neuroscience education and mind-body exercises in patients with knee osteoarthritis
Acronym Effect of pain neuroscience education and mind-body exercises in patients with knee osteoarthritis
Scientific Title Effect of pain neuroscience education and mind-body exercises in patients with knee osteoarthritis
Scientific Title:Acronym Effect of pain neuroscience education and mind-body exercises in patients with knee osteoarthritis
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 Effect of pain neuroscience education and mind-body exercises in patients with knee osteoarthritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain intensity
Key secondary outcomes function, pain catastrophizing, kinesiophobia, and self- efficacy

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 Educational,Counseling,Training
Type of intervention
Medicine
Interventions/Control_1 Pain neuroscience education and Pilates exercise
Interventions/Control_2 Pilates exercise
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
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria were Persian-native speaker male and female;were above 45 years old;primary complaint of knee pain diagnosed as knee OA
Key exclusion criteria self-reported knee replacement or any other lower limb surgery 6 months prior to participation;history of inflammatory;metabolic or neurological disease;knee ligament or meniscus injury in previous year;any mental health conditions;therapeutic modalities 6 months before participation.
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Pouya
Middle name
Last name Rabiei
Organization Islamic azad 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 "Kharazmi University"
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 Sport science research center
Address tehran
Tel 00982122258084
Email ssri.ethics.c@gmail.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 06 Month 05 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 54
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
2020 Year 06 Month 28 Day
Date of IRB
2021 Year 05 Month 29 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2021 Year 06 Month 17 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 06 Month 05 Day
Last modified on
2021 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050769

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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