UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044507 |
|---|---|
| Receipt number | R000050848 |
| Scientific Title | Factors associated with test-retest reliability of central sensitization in elderly people with pain |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2023/03/24 10:40:32 |
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Basic information
Public title
Factors associated with test-retest reliability of central sensitization in elderly people with pain
Acronym
Factors associated with test-retest reliability of central sensitization in elderly people with pain
Scientific Title
Factors associated with test-retest reliability of central sensitization in elderly people with pain
Scientific Title:Acronym
Factors associated with test-retest reliability of central sensitization in elderly people with pain
Region
| Japan |
Condition
Condition
elderly people with pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is difficult to evaluate central sensitization becuase the method assessing central sensitization has low reliability. The reasons of low reliability of this assessment is not revealed. Therefore, this study aims to make it clear the factors to decrease the reliability of the assessment of central sensitization.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
conditioned pain moudulation (two times, the interval is two weeks between the first and second evaluation)
Key secondary outcomes
physical activity
information of medication
body composition
pain intensity
blood test
depression and anxiety
(all secondary outcomes will be evaluated in the first time)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
blood test
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
elderly people with pain
Key exclusion criteria
pain caused by cancer
head, face and stomach pain
history of operation
sleep disorder
chain smoker
alcohol dependence
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
Self funding
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 | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000050848
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/articles.php?article_id=82486
Number of participants that the trial has enrolled
32
Results
Thirty-two participants were divided into two groups chronic pain and non-chronic pain groups.The mean difference between session 1 and 2 in CPM index showed a systematic error in the chronic pain group at 17.3 (confidence interval CI 15.0 to 19.7) but none in the non-chronic pain group at 3.7 (CI -0.02 to 7.4). Multivariate regression analysis revealed total power and low/high frequencies as significant factors for CPM index.
Results date posted
| 2023 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Community dwelling older people aged 65 or over
Participant flow
Participants were recruited via advertisements at a job placement and community support center, and informed consents were given if the participants agreed with the study.
Adverse events
None.
Outcome measures
Heart rage, blood pressure, heart rate variability, pressure pain threshold, participants' characteristics.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2023 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050848
