UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035149 |
|---|---|
| Receipt number | R000040059 |
| Scientific Title | The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0 |
| Date of disclosure of the study information | 2018/12/06 |
| Last modified on | 2024/04/02 14:39:02 |
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Basic information
Public title
The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0
Acronym
The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0
Scientific Title
The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0
Scientific Title:Acronym
The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0
Region
| Japan |
Condition
Condition
pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relation between pain intensity and disability with WHODAS2.0.
Basic objectives2
Others
Basic objectives -Others
To assess the change of disability with therapies in pain clinic.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
pain intensity (NRS) and disability (WHODAS2.0). they were interviewed on baseline, 1,3,6,12 months after registrasion.
Key secondary outcomes
1. Euro QOL 5D5L Japanese version
2. Functional Independence Measure
3. Hospital Anxiety and Depression Scale
4. Pain Catastrophizing Scale
5. the habit of regular exercise
6. Perceived Stress Scale Japanese version
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with pain who is over 50 years old
Key exclusion criteria
The patient who can not answer the Questionnaires, for example, who can not understand Japanese, who has severe dementia or intellectual disability.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Fujiwara |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
840 shijo-cho, Kashihara, Nara
TEL
+81-744-29-8902
higemo1117@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Fujiwara |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
840 shijo-cho, Kashihara, Nara
TEL
+81-744-29-8902
Homepage URL
http://www.naramed-u.ac.jp/~anes/
higemo1117@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University, Department of Anesthesiology
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
Nara Medical University Ethics Committee
Address
840 shijo-cho, Kashihara, Nara
Tel
+81744298902
ino_rinri@naramed-u.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
奈良県立医科大学附属病院(奈良県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is an observational study for all patients with pain.
Management information
Registered date
| 2018 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040059
