UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007437 |
|---|---|
| Receipt number | 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 23:12:43 |
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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
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
Sponsor or person
Institute
Department of Pain Medicine, Osaka University Graduate school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008766
