UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050190 |
|---|---|
| Receipt number | R000057159 |
| Scientific Title | Development of a linguistically validated Japanese version of The Parkinson's Disease Pain Classification System (PD-PCS) |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2024/02/01 11:43:40 |
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Basic information
Public title
Development of a Japanese version of a pain questionnaire (The Parkinson's Disease Pain Classification System: PD-PCS) for Parkinson's disease patients
Acronym
Development of a Japanese version of a pain questionnaire (PD-PCS) for Parkinson's disease patients
Scientific Title
Development of a linguistically validated Japanese version of The Parkinson's Disease Pain Classification System (PD-PCS)
Scientific Title:Acronym
Development of a linguistically validated Japanese version of the PD-PCS
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Medicine in general | Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a linguistically validated Japanese version of The Parkinson's Disease Pain Classification System (PD-PCS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on ease of answering to the Japanese provisional version of the PD-PCS
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of Parkinson's disease by a neurologist
2) Patient must be ON at the time of examination/observation
3) Written consent must be obtained from the individual to participate in the research
Key exclusion criteria
1) Mini Mental State Examination score of 23 or less
2) Patients treated with Deep Brain Stimulation or Levodopa-Carbidopa Intestinal Gel
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Ishida |
Organization
Shimane University Hospital
Division name
Rehabilitation department
Zip code
6938501
Address
89-1, Enya cho, Izumo-city, Shiamne-ken
TEL
0853202457
ishida@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Ishida |
Organization
Shimane University Hospital
Division name
Rehabilitation department
Zip code
6938501
Address
89-1, Enya cho, Izumo-city, Shimane-ken
TEL
0853202457
Homepage URL
ishida@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Prefectural University of Hiroshima
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1, Enya cho, Izumo-city, Shimane-ken
Tel
0853202515
kenkyu@med.shimane-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 31 | 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
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
This is a study to develop a Japanese version of the questionnaire for patients with Parkinson's disease. The primary outcome is measured by a questionnaire on the ease of answering the questionnaire form. Pain-related indicators are also assessed.
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057159
