UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of rehabilitation after surgical treatment of trigger finger
Acronym	The effectiveness of rehabilitation after surgical treatment of trigger finger
Scientific Title	The effectiveness of rehabilitation after surgical treatment of trigger finger
Scientific Title:Acronym	The effectiveness of rehabilitation after surgical treatment of trigger finger
Region	Japan

Condition
Condition	Trigger Finger
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effectiveness of rehabilitation after surgical treatment of trigger finger
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Finger range of motion before and after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Rehabilitation for three months after surgery
Interventions/Control_2	No Rehabilitation after surgery
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients operated for trigger finger 2. patients who can express their will to attend the research.
Key exclusion criteria	1. Patients with several trigger fingers in the affected side. 2. Patients with rheumatoid arthritis 3. Patients with osteoarthritis or malunion after finger fracture 4. Patients judged inadequacy by members of the research project.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Taichi Middle name Last name Saito
Organization	Okayama University Hospital
Division name	Department of Orthopaedic Surgery
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kitaku
TEL	0862357273
Email	umehachi55@gmail.com

Public contact
Name of contact person	1st name Taichi Middle name Last name Saito
Organization	Okayama University Hospital
Division name	Department of Orthopaedic Surgery
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kitaku
TEL	086-235-7273
Homepage URL
Email	umehachi55@gmail.com

Sponsor
Institute	Okayama university
Institute
Department

Funding Source
Organization	Own fund
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JP

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Orthopaedic Surgery Okayama University Hospital
Address	2-5-1, Shikata-cho, Kitaku, Okayama City
Tel	086-235-7273
Email	umehachi55@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	2019 Year 03 Month 12 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	2019 Year 03 Month 12 Day
Date of IRB	2019 Year 03 Month 19 Day
Anticipated trial start date	2019 Year 03 Month 19 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	2019 Year 03 Month 08 Day
Last modified on	2022 Year 09 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038218