UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019781 |
|---|---|
| Receipt number | R000022729 |
| Scientific Title | Assessment of the effectiveness of a custom-made functional splint by three dimensionally cuting Neoprane for osteoarthritis of the trapeziometacarpal joint |
| Date of disclosure of the study information | 2015/11/13 |
| Last modified on | 2017/05/15 20:20:47 |
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Basic information
Public title
Assessment of the effectiveness of a custom-made functional splint by three dimensionally cuting Neoprane for osteoarthritis of the trapeziometacarpal joint
Acronym
Assessment of the effectiveness of a custom-made functional splint by Neoprane for osteoarthritis of the trapeziometacarpal joint
Scientific Title
Assessment of the effectiveness of a custom-made functional splint by three dimensionally cuting Neoprane for osteoarthritis of the trapeziometacarpal joint
Scientific Title:Acronym
Assessment of the effectiveness of a custom-made functional splint by Neoprane for osteoarthritis of the trapeziometacarpal joint
Region
| Japan |
Condition
Condition
trapeziometacarpal joint osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the effectiveness of a custom-made functional splint by Neoprane
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Pain
Assessment time point
1.Before putting the splint
2.One week
3.One month
4.Three months
5.Five months
Scoring method
1.Visual Analog Scale (VAS)
2.Patient-Rated Wrist Evaluation The Japanese Version
Key secondary outcomes
Grip strength, Pulp Pinch strength, Function
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
| Other |
Interventions/Control_1
Splinting
Duration: 5 months
Number: one splint
Put the splint all day long.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed as the trapeziometacarpal joint osteoarthritis and affirdable for splinting.
Obtained consent.
Key exclusion criteria
Mental illness
dementia
current trauma of the same finger
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morita Sadao |
Organization
Tokyo Medical and Dental University Hospital of Medicine
Division name
Rehabilitation
Zip code
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5648
morita.reh@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yanagihara Hiroshi |
Organization
Tokyo Medical and Dental University Hospital of Medicine
Division name
Rehabilitation
Zip code
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5648
Homepage URL
yanagihara.phyt@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University Hospital of Medicine
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
| 2015 | Year | 11 | Month | 13 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 13 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022729
