UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016328 |
|---|---|
| Receipt number | R000018948 |
| Scientific Title | Examination of clinical improvement and postoperative complications preventive effect by Neurotropin as a preemptive analgegia for open carpal tunnel release |
| Date of disclosure of the study information | 2015/01/26 |
| Last modified on | 2015/01/25 03:18:37 |
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Basic information
Public title
Examination of clinical improvement and postoperative complications preventive effect by Neurotropin as a preemptive analgegia for open carpal tunnel release
Acronym
The efficacy of Noirotropin as a preemptive analgegia for open carpal tunnel release
Scientific Title
Examination of clinical improvement and postoperative complications preventive effect by Neurotropin as a preemptive analgegia for open carpal tunnel release
Scientific Title:Acronym
The efficacy of Noirotropin as a preemptive analgegia for open carpal tunnel release
Region
| Japan |
Condition
Condition
carpal tunnel syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy of clinical improvement and postoperative complications preventive effect of postoperative by taking Neurotropin before open carpal tunnel release.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
VAS scale of pain and numbness, the Quick DASH and carpal tunnel syndrome severity score Japan Tegeka Society version severity score are used as a functional evaluation. We evaluate each patient on the first visit, preoperative, postoperative 1 month, 3 months, 6 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Noirotropin and Vitamin B12
Interventions/Control_2
Vitamin B12
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
Patient with carpal tunnel syndrome
Key exclusion criteria
Patient with carpal tunnel syndrome which induced by trauma
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenmoku Tomonori |
Organization
Kitasato university school of medicine
Division name
Orthopaedic surgery
Zip code
Address
Kitasato 1-15-1, Minami-ku Sagamihara city Kanagawa
TEL
042-778-8111
pseudolefty811@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenmoku Tomonori |
Organization
Kitasato university school of medicine
Division name
Orthopaedic surgery
Zip code
Address
Kitasato 1-15-1, Minami-ku Sagamihara city Kanagawa
TEL
042-778-8111
Homepage URL
pseudolefty811@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopedic surgery, Kitasato university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Zoki
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北里大学東病院 東京女子医科大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Improvement of numbness was observed in patients from preoperative 50% by oral of Neurotropin. Score on the significant difference between the Neurotropin oral group and the non-oral group at any point in time that was measured was not observed. But Quick DASH, but significant improvement was obtained from 1 month after surgery compared with the time of the first visit in the oral group in severity score both (Quick DASH: p <0.05, severity score: p <0.0001), non-oral group in a significant improvement is obtained at postoperative 3 months later (Quick DASH: p <0.05, severity score: p <0.01). Also without have improvement of subjective symptoms is obtained preoperatively had obtained functional improvement of early postoperative period.
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
| 2012 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 29 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 29 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 25 | Day |
Last modified on
| 2015 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018948
