UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034940 |
|---|---|
| Receipt number | R000039767 |
| Scientific Title | Survey on central sensitization syndrome associated intractable diseases |
| Date of disclosure of the study information | 2018/12/30 |
| Last modified on | 2020/11/20 09:01:59 |
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Basic information
Public title
Survey on central sensitization syndrome associated intractable diseases
Acronym
Survey on central sensitization
Scientific Title
Survey on central sensitization syndrome associated intractable diseases
Scientific Title:Acronym
Survey on central sensitization
Region
| Japan |
Condition
Condition
Central sensitization syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a survey on the Central Sensitization Inventory
in Japanese patients with central sensitization syndrome.
Basic objectives2
Others
Basic objectives -Others
To assesses relationship between QOL, pain and depression.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central Sensitization Inventory
Key secondary outcomes
Patient Health Questionnaire (PHQ)-9
Brief Pain Inventory
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diseases associated with the central sensitization syndrome.
Migraine/Tension-type headache
Chronic fatigue syndrome
Chronic low back pain
Depression/Anxiety disorders
Restless Legs Syndrome
Irritable bowel syndrome
Chemical Sensitivity
Key exclusion criteria
Patient without consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Saeki |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Department of pallative therapy
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo
TEL
03-3520-0111
yoshinori.saeki@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Saeki |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Department of pallative therapy
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo
TEL
03-3520-0111
Homepage URL
yoshinori.saeki@jfcr.or.jp
Sponsor or person
Institute
Dokkyo university of medicine
Department of neurology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital Of JFCR
Address
3-8-31, Ariake, Koto, Tokyo
Tel
03-3520-0111
yoshinori.saeki@jfcr.or.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
| 2018 | Year | 12 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 11 | Month | 19 | Day |
Last modified on
| 2020 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039767
