UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044506 |
|---|---|
| Receipt number | 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 | 2023/04/30 17:16:28 |
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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
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
h.uzawa@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050846
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
