UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of Electromyogram in thenar muscles for Thumb Carpometacarpal Osteoarthritis.
Acronym	Analysis of Electromyogram in thenar muscles for Thumb Carpometacarpal Osteoarthritis.
Scientific Title	Analysis of Electromyogram in thenar muscles for Thumb Carpometacarpal Osteoarthritis.
Scientific Title:Acronym	Analysis of Electromyogram in thenar muscles for Thumb Carpometacarpal Osteoarthritis.
Region	Japan

Condition
Condition	Carpometacarpal Osteoarthritis
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of Electromyogram in thenar muscles
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electromyogram
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	25 years-old <=
Age-upper limit	61 years-old >
Gender	Male
Key inclusion criteria	Volunteer adults with written consent after explaining the experimental method
Key exclusion criteria	Persons with disabilities in the upper limbs
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Akio Middle name Last name Okano
Organization	Graduate School, Niigata University of Health and Welfare
Division name	Major in Health and Welfare
Zip code	9503198
Address	1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL	0252574455
Email	okano@isc.chubu.ac.jp

Public contact
Name of contact person	1st name Akio Middle name Last name Okano
Organization	Graduate School, Niigata University of Health and Welfare
Division name	Major in Health and Welfare
Zip code	9503198
Address	1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL	0252574455
Homepage URL
Email	okano@isc.chubu.ac.jp

Sponsor
Institute	Niigata University of Health and Welfare
Institute
Department

Funding Source
Organization	Niigata University of Health and Welfare
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	Niigata University of Health and Welfare
Address	1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel	0252574455
Email	okano@isc.chubu.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

Other administrative information
Date of disclosure of the study information	2021 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	Preinitiation
Date of protocol fixation	2021 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2021 Year 11 Month 13 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation test

Management information
Registered date	2021 Year 11 Month 12 Day
Last modified on	2021 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052571