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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039143
Receipt No. R000044638
Scientific Title Randomized parallel-group study of dynamic splint for PIP joint flexion contracture associated with trigger finger
Date of disclosure of the study information 2020/04/01
Last modified on 2020/01/14

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Basic information
Public title Examination of the effect of orthosis treatment for joint contracture associated with tendinitis
Acronym Study of tendinitis
Scientific Title Randomized parallel-group study of dynamic splint for PIP joint flexion contracture associated with trigger finger
Scientific Title:Acronym Study of trigger finger
Region
Japan

Condition
Condition trigger finger
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of dynamic splint on flexion contracture of PIP joint associated with trigger finger
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes flexion contracture angle of PIP joint
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 Patients in the control group have only normal rehabilitation such as range-of-motion training.
Interventions/Control_2 Patients in the intervention group have not only normal rehabilitation but also orthosis therapy using a dynamic splint.
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 Adults over the age of 20 who can agree to have surgery
Key exclusion criteria Adults over the age of 20 who can not agree to have surgery
Children
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Fumiaki
Middle name
Last name Takase
Organization Kobe Rosai Hospital
Division name Orthopaedics
Zip code 651-0053
Address 4-1-23, Kagoikedori, Chuoku, Kobe, Hyogo
TEL 078-231-5901
Email ff.takase@gmail.com

Public contact
Name of contact person
1st name Fumiaki
Middle name
Last name Takase
Organization Kobe Rosai Hospital
Division name Orthopaedics
Zip code 651-0053
Address 4-1-23, Kagoikedori, Chuoku, Kobe, Hyogo
TEL 078-231-5901
Homepage URL
Email ff.takase@gmail.com

Sponsor
Institute Kobe Rosai Hospital
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health and Safety
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 Kobe Rosai Hospital
Address 4-1-23, Kagoikedori, Chuoku, Kobe, Hyogo
Tel 078-231-5901
Email ff.takase@gmail.com

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
2020 Year 04 Month 01 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
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 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
2020 Year 01 Month 14 Day
Last modified on
2020 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044638

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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