UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029801 |
|---|---|
| Receipt number | R000034041 |
| Scientific Title | The effectiveness of Graded Mirror Therapy based on the assessment of mirrored limb perception to the patients with complex regional pain syndrome |
| Date of disclosure of the study information | 2017/11/03 |
| Last modified on | 2019/05/07 21:25:36 |
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Basic information
Public title
The effectiveness of Graded Mirror Therapy based on the assessment of mirrored limb perception to the patients with complex regional pain syndrome
Acronym
The effectiveness of Graded Mirror Therapy based on the assessment of mirrored limb perception to the patients with complex regional pain syndrome
Scientific Title
The effectiveness of Graded Mirror Therapy based on the assessment of mirrored limb perception to the patients with complex regional pain syndrome
Scientific Title:Acronym
The effectiveness of Graded Mirror Therapy based on the assessment of mirrored limb perception to the patients with complex regional pain syndrome
Region
| Japan |
Condition
Condition
Complex regional pain syndrome
Classification by specialty
| Orthopedics | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal whether graded mirror therapy based on the assessment of mirrored limb perception is effective compared to conventional mirror therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Graded mirror therapy 12 weeks
Interventions/Control_2
Conventional mirror therapy 12 weeks
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed complex regional pain syndrome according to Budapest criteria
Key exclusion criteria
Patients with psychiatric disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Mibu |
Organization
Konan Women's University
Division name
Department of Nursing and physical therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
0784133691
a_mibu@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Mibu |
Organization
Konan Women's University
Division name
Department of Nursing and physical therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, Hyogo
TEL
0784133691
Homepage URL
a_mibu@konan-wu.ac.jp
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
No
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
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
| 2017 | Year | 11 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 11 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034041
