UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041286 |
|---|---|
| Receipt number | R000047043 |
| Scientific Title | Efficacy and the safety of genicular nerveve pulsed radiofrequency treatment for Japanese patients |
| Date of disclosure of the study information | 2020/08/15 |
| Last modified on | 2025/02/05 11:33:46 |
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Basic information
Public title
Efficacy and the safety of genicular nerveve pulsed radiofrequency treatment for Japanese patients
Acronym
Efficacy and the safety of genicular nerveve pulsed radiofrequency treatment for Japanese patients
Scientific Title
Efficacy and the safety of genicular nerveve pulsed radiofrequency treatment for Japanese patients
Scientific Title:Acronym
Efficacy and the safety of genicular nerveve pulsed radiofrequency treatment for Japanese patients
Region
| Japan |
Condition
Condition
chronic knee pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of genicular nerve pulsed radiofrequency treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inprovement of the pain score after the pulsed rediofrequency treatment; Numerical Rating Scale(NRS) one week after, 6 months after and 12 months after the treatment
Key secondary outcomes
adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
clonic knee patients without the indication of surgery
Key exclusion criteria
patients who are contraindicated to block procedure
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Department of Anesthesiology and Pain Clinic
Zip code
130-8575
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL
03-3633-6151
hirano-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Bokutoh Hospital
Division name
Department of Anesthesiology and Pain Clinic
Zip code
130-8575
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
TEL
03-3633-6151
Homepage URL
hirano-a@umin.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Bokutoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Bokutoh Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tokyo Metropolitan Bokutoh Hospital
Address
4-23-15 Kotobashi, Sumida-ku, Tokyo
Tel
03-3633-6151
hirano-a@umin.ac.jp
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 | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The candidate of this study is the patients who comes to our pain clinic and who are not eligible for the knee surgery. They will be tried the block only with the local anesthetics and if it works, this procedure will be applied. The period will be determined depending on the number of the accumulated patients.
Management information
Registered date
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047043
