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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044506
Receipt No. R000050846
Scientific Title Factors associated with changes in pressure pain threshold after exercise in people with chronic musculoskeletal pain
Date of disclosure of the study information 2021/06/11
Last modified on 2021/06/11

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Basic information
Public title Factors associated with changes in pressure pain threshold after exercise in people with chronic musculoskeletal pain
Acronym Factors associated with changes in pressure pain threshold after exercise in people with chronic musculoskeletal pain
Scientific Title Factors associated with changes in pressure pain threshold after exercise in people with chronic musculoskeletal pain
Scientific Title:Acronym Factors associated with changes in pressure pain threshold after exercise in people with chronic musculoskeletal pain
Region
Japan

Condition
Condition chronic musculoskeletal pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Chronic musculoskeletal pain might be caused by a problem of central nervous system; not by joint degeneration itself. The dysfunction of central nervous system is called as central sensitization. A problem in clinical practice is that it is difficult to evaluate whether patients have central sensitization or not. Central sensitization is led to a dysfunction of the rostral ventromedial medulla, which controls autonomic nervous system and blood pressure. Therefore, this study aims to confirm the hypothesis that central sensitization is associated with autonomic dysfunction.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pressure pain threshold (rest and the time activated sympathetic nervous system like after exercise)
Key secondary outcomes haert rate variablity(rest and the time activated sympathetic nervous system like after exercise)
blood pressure(rest and the time activated sympathetic nervous system like after exercise)
physical activity (before this study started)
depressio and anxiety (before this study started)
pain catastrophizing (before this study started)
central sensitization (before this study started)


Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria knee and hip osteoarthritis
Key exclusion criteria dysfunction of endocrine, immune, cardiovascular, or autonomic system
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hironobu
Middle name
Last name Uzawa
Organization International University of Health and Welfare
Division name School of Health Science at Narita, Department of Physical Therapy
Zip code 286-8686
Address 4-3, Kozunomori, Narita-shi,Chiba-ken
TEL +81-476-20-7701
Email h.uzawa@iuhw.ac.jp

Public contact
Name of contact person
1st name Hironobu
Middle name
Last name Uzawa
Organization International University of Health and Welfare
Division name School of Health Science at Narita, Department of Physical Therapy
Zip code 286-8686
Address 4-3, Kozunomori, Narita-shi,Chiba-ken
TEL +81-476-20-7701
Homepage URL
Email h.uzawa@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization International University of Health and Welfare
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 International University of Health and Welfare
Address 4-3, Kozunomori, Narita-shi,Chiba-ken
Tel +81-476-20-7701
Email h.uzawa@iuhw.ac.jp

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 11 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
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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 31 Day
Date of IRB
2020 Year 03 Month 31 Day
Anticipated trial start date
2020 Year 03 Month 31 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no statement

Management information
Registered date
2021 Year 06 Month 11 Day
Last modified on
2021 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050846

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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