UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the effectiveness of a custom-made functional splint by three dimensionally cuting Neoprane for osteoarthritis of the trapeziometacarpal joint
Title of the study (Brief title)	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	Morita Sadao
Organization	Tokyo Medical and Dental University Hospital of Medicine
Division name	Rehabilitation
Address	1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL	03-5803-5648
Email	morita.reh@tmd.ac.jp

Public contact
Name of contact person	Yanagihara Hiroshi
Organization	Tokyo Medical and Dental University Hospital of Medicine
Division name	Rehabilitation
Address	1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL	03-5803-5648
Homepage URL
Email	yanagihara.phyt@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022729