UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036137 |
|---|---|
| Receipt number | R000038218 |
| Scientific Title | The effectiveness of rehabilitation after surgical treatment of trigger finger |
| Date of disclosure of the study information | 2019/03/12 |
| Last modified on | 2022/09/09 09:12:59 |
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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
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
umehachi55@gmail.com
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038218
