UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041117 |
|---|---|
| Receipt number | R000046957 |
| Scientific Title | Relation between patient-based scoring system and physical activity and sleep monitoring: Possibility for objective measures. |
| Date of disclosure of the study information | 2020/07/15 |
| Last modified on | 2023/10/17 11:20:08 |
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Basic information
Public title
Effectiveness of physical activity and sleep monitoring in chronic pain patients as treatment measures.
Acronym
Physical activity and sleep monitoring in chronic pain patients.
Scientific Title
Relation between patient-based scoring system and physical activity and sleep monitoring: Possibility for objective measures.
Scientific Title:Acronym
Relation between patient-based scoring system and objective measures of physical activity and sleep.
Region
| Japan |
Condition
Condition
Patients with post-herpetic neuralgia for over 3 months
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the correlation between objective monitoring of activity/sleep and self report in patients with postherpetic neuralgia.
Basic objectives2
Others
Basic objectives -Others
Analysis of patient factors which determine activity level and sleep efficacy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between activity level measured by wearable trackers and self-reported pain disability assessment scale.
Key secondary outcomes
Relation between sleep efficacy measured by wearable trackers and self-reported insomnia severity index.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with post-herpetic neuralgia for over 3 month.
Key exclusion criteria
Neuralgia on non-dominant hand
Patients with low activity due to other complications
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shiroh |
| Middle name | |
| Last name | Isono |
Organization
Chiba University
Division name
Graduate School of Medicine
Zip code
260-8670
Address
1-8-1 Inohana Chuo Chiba Japan
TEL
0432227171
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Natsuko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University Hospital
Division name
Graduate School of Medicine, Anesthesiology
Zip code
260-8670
Address
1-8-1 Inohana Chuo Chiba Japan
TEL
0432227171
Homepage URL
nnoztag@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
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
Chiba University Graduate School of Medicine
Address
1-8-1 Inohana Chuo Chiba
Tel
0432227171
igaku-rinri@office.chiba-u.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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 15 | 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
| 2019 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046957
