UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011209 |
|---|---|
| Receipt number | R000013139 |
| Scientific Title | Evaluation of radio frequency for chronic pain. Retrospective observation study |
| Date of disclosure of the study information | 2013/07/17 |
| Last modified on | 2014/08/25 19:41:18 |
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Basic information
Public title
Evaluation of radio frequency for chronic pain.
Retrospective observation study
Acronym
Evaluation of radio frequency for chronic pain.
Scientific Title
Evaluation of radio frequency for chronic pain.
Retrospective observation study
Scientific Title:Acronym
Evaluation of radio frequency for chronic pain.
Region
| Japan |
Condition
Condition
Patients wit chronic intractable pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment for the efficacy and safety of high-frequency thermal coagulation for the patients with chronic pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual Analogue Scale(VAS : 0-100mm) Baseline(before procedure) ,1day, 3, 6, and 12 months after procedure.
Key secondary outcomes
Changes in oral medication and influence to sleep disturbance.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
high-frequency thermal coagulation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with chronic pain
Key exclusion criteria
nerve root irritation, haemocoagulation disorders
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noritaka Yoshimura |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
1-1Yanagito, Gifu-shi
TEL
0582306000
mcbyq256@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noritaka Yoshimura |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
1-1Yanagito, Gifu-shi , Japan
TEL
0582306000
Homepage URL
mcbyq256@yahoo.co.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 17 | Day |
Last modified on
| 2014 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013139
