UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056080 |
|---|---|
| Receipt number | R000064079 |
| Scientific Title | Exploring risk factors for chronicity of pain and disability in patients with complex regional pain syndrome. |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 20:13:50 |
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Basic information
Public title
Exploring risk factors for chronicity of pain and disability in patients with complex regional pain syndrome.
Acronym
Exploring risk factors for chronicity in patients with complex regional pain syndrome.
Scientific Title
Exploring risk factors for chronicity of pain and disability in patients with complex regional pain syndrome.
Scientific Title:Acronym
Exploring risk factors for chronicity of pain and disability in patients with complex regional pain syndrome.
Region
| Japan |
Condition
Condition
complex regional pain syndrome
Classification by specialty
| Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine factors influencing the effectiveness of multimodal rehabilitation programmes for CRPS from a comprehensive assessment of the symptoms and signs of CRPS and to identify risk factors for chronicity of pain and disability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity and degree of disability 6, 12 months after the start of the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Multimodal rehabilitation comprising patient education, exercise therapy, mirror therapy and exposure therapy.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CRPS patients aged 18 years and over who meet the Budapest Criteria and have been prescribed rehabilitation by a doctor.
Key exclusion criteria
1. those with significant cognitive problems
2. those whose mental illness is considered to have a significant impact on their CRPS symptoms
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Mibu |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo, Japan
TEL
078-413-3583
a_mibu@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Mibu |
Organization
Konan Women's University
Division name
Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo, Japan
TEL
078-413-3583
Homepage URL
a_mibu@konan-wu.ac.jp
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
other
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
Konan Women's University Research Ethics Committee
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyog
Tel
078-413-3972
gakuken@konan-wu.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
田辺整形外科，大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 06 | 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 | 11 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064079
