UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052831 |
|---|---|
| Receipt number | R000057138 |
| Scientific Title | The features of pain threshold in Parkinson's syndrome |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2023/11/17 22:47:25 |
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Basic information
Public title
The features of pain threshold in Parkinson's syndrome
Acronym
The features of pain threshold in Parkinson's syndrome
Scientific Title
The features of pain threshold in Parkinson's syndrome
Scientific Title:Acronym
The features of pain threshold in Parkinson's syndrome
Region
| Japan |
Condition
Condition
Parkinson's disease, multiple system atrophy, progressive supranuclear palsy
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with Parkinson's disease (PD), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and other Parkinsonian syndromes often complain of pain, which is closely associated with a decreased quality of life. Although it has been reported that PSP patients complain of pain less frequently than PD and MSA patients, few reports have examined this in detail. However, the Pain Vision pain quantification system (Pain Vision), which was developed by Nipro Corporation in 2013 to quantitatively evaluate pain, has been put to practical use, making it possible to objectively evaluate pain. In this study, we measured pain thresholds using Pain Vision in patients with three typical Parkinson's syndromes (PD, MSA, and PSP), and examined the characteristics of the pain thresholds.
Basic objectives2
Others
Basic objectives -Others
Compare pain thresholds
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare pain thresholds for PD patients, MSA patients, PSP patients, and healthy subjects.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PD group: patients with Parkinson's disease aged 20 years or older (meet the MDS diagnostic criteria 2015 for "clinically certain Parkinson's disease".
MSA group: patients with multiple system atrophy aged 20 years and older (meet the Gilman classification second consensus criteria "Probable".
PSP group: Patients with progressive supranuclear palsy aged 20 years or older (meet the NINDS-SPSP diagnostic criteria for "Probable").
Normal subjects: Normal subjects without underlying disease.
Key exclusion criteria
MMSE score of 27 or lower
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Saitama Medical University Hospital
Division name
department of neurology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan
TEL
049-276-1111
kawasaki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Saitama Medical University Hospital
Division name
department of neurology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan
TEL
049-276-1111
Homepage URL
kawasaki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Hitoshi Kawasaki
Funding Source
Organization
Saitama Medical University Hospital
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
Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan
Tel
049-276-1111
kawasaki@saitama-med.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
| 2025 | Year | 11 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pain thresholds will be compared for PD patients, MSA patients, PSP patients, and healthy subjects enrolled during the study period. Results of cognitive function (MoCA-J), motor function (UPDRS part III), pain assessment (NRS, King's PD pain scale), depression assessment (Beck Depression Scale), dopamine transporter scintigraphy and MIBG cardiac scintigraphy will also be compared. The results of dopamine transporter scintigraphy and MIBG myocardial scintigraphy will be compared. The effects of age, duration of illness, presence of chronic pain, and type of medication on pain thresholds will also be analyzed.
Management information
Registered date
| 2023 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057138
