UMIN-CTR Clinical Trial

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