UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Controlled clinical trial for evaluation of effects of the stretch for trigger finger
Title of the study (Brief title)	Controlled clinical trial for evaluation of effects of the stretch for trigger finger
Region	Japan

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

Objectives
Narrative objectives1	evaluation of effects of the stretch
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	recurrence of local tenderness
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	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	a corticosteroid injection
Interventions/Control_2	stretch(more than 4 weeks)
Interventions/Control_3	injection plus stretch
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	Not applicable
Gender	Male and Female
Key inclusion criteria	trigger finger
Key exclusion criteria	occupational therapy session was less than 3 times
Target sample size	60

Research contact person
Name of lead principal investigator	Nahoko Iwakura
Organization	Tokyo Women's Medical University
Division name	Orthopaedic Surgery
Address	8-1 Kawada-cho Sinjyuku city, Tokyo
TEL	03-3353-8111
Email	niwakura@qf7.so-net.ne.jp

Public contact
Name of contact person	Nahoko Iwakura
Organization	Tokyo Women's Medical University
Division name	Orthopaedic Surgery
Address	8-1 Kawada-cho Sinjyuku city, Tokyo
TEL	03-3353-8111
Homepage URL
Email	niwakura@qf7.so-net.ne.jp

Sponsor
Institute	Sakura Orthopedic Hospital
Institute
Department

Funding Source
Organization	none
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	佐倉整形外科病院(千葉県)

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 08 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
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 12 Month 08 Day
Last modified on	2016 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023240