UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044440 |
|---|---|
| Receipt number | 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 03:43:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
letafatkaramir@yahoo.com
Sponsor or person
Institute
"Kharazmi University"
Institute
Department
Personal name
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
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
Value
https://center6.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 |
