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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034940
Receipt No. R000039767
Scientific Title Survey on central sensitization syndrome associated intractable diseases
Date of disclosure of the study information 2018/12/30
Last modified on 2018/11/19

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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
Middle name
Last name Yoshinori Saeki
Organization The Cancer Institute Hospital Of JFCR
Division name Department of pallative therapy
Zip code
Address 3-8-31, Ariake, Koto, Tokyo
TEL 03-3520-0111
Email yoshinori.saeki@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Saeki
Organization The Cancer Institute Hospital Of JFCR
Division name Department of pallative therapy
Zip code
Address 3-8-31, Ariake, Koto, Tokyo
TEL 03-3520-0111
Homepage URL
Email yoshinori.saeki@jfcr.or.jp

Sponsor
Institute Dokkyo university of medicine
Department of neurology
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 30 Day
Last follow-up date
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
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039767

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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