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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007437
Receipt No. R000008766
Scientific Title Development of Complex Regional Pain Syndrome (CRPS) Severity Score As A Clinical Tool To Monitor Disease Progression
Date of disclosure of the study information 2012/04/01
Last modified on 2012/03/04

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Basic information
Public title Development of Complex Regional Pain Syndrome (CRPS) Severity Score As A Clinical Tool To Monitor Disease Progression
Acronym Development of Complex Regional Pain Syndrome (CRPS) Severity Score
Scientific Title Development of Complex Regional Pain Syndrome (CRPS) Severity Score As A Clinical Tool To Monitor Disease Progression
Scientific Title:Acronym Development of Complex Regional Pain Syndrome (CRPS) Severity Score
Region
Japan

Condition
Condition Complex Regional Pain Syndrome
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary aim is to determine if the CRPS severity score can be used as a clinical bedside tool to monitor CRPS change in symptoms over time, specifically progression or regression.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome measures will include the following: 1) a database sheet recording CRPS-related signs and symptoms displayed during the history and physical examination, 2) The McGill Pain Questionnaire-Short Form (MPQ-SF)6, 3) the SF-367 (with validated versions available in many languages, including Dutch, German, and Hebrew), 4) Pain and Anxiety Symptoms Scale8 (PASS-20), 5) Pain Disability Index9 (PDI), 6) Center for Epidemiologic Studies Short Depression Scale10 (CESD-10), 7) Occupational Status Questionnaire (OSQ), and 8) Patient Global Impression of Change (PGIC).
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 patients that meet the 2011 provisional IASP diagnostic criteria for CRPS
Key exclusion criteria patients that don't meet the 2011 provisional IASP diagnostic criteria for CRPS
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Shibata
Organization Osaka University Graduate school of Medicine
Division name Department of Pain Medicine
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka Pref, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate school of Medicine
Division name Department of Pain Medicine
Zip code
Address
TEL 06-6879-3133
Homepage URL
Email

Sponsor
Institute Department of Pain Medicine, Osaka University Graduate school of Medicine
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization
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
2012 Year 04 Month 01 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
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no data

Management information
Registered date
2012 Year 03 Month 04 Day
Last modified on
2012 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008766

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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