UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005030 |
|---|---|
| Receipt number | R000005983 |
| Scientific Title | Effects of Pulsed Radiofrequency Treatment of the Thoracic Paravertebral Nerve for Postherpetic Neuralgia: A Randomized, Double-Blind, Active Controlled Trial |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2021/08/23 18:36:50 |
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Basic information
Public title
Effects of Pulsed Radiofrequency Treatment of the Thoracic Paravertebral Nerve for Postherpetic Neuralgia: A Randomized, Double-Blind, Active Controlled Trial
Acronym
Effects of PRF-TPN for PHN
Scientific Title
Effects of Pulsed Radiofrequency Treatment of the Thoracic Paravertebral Nerve for Postherpetic Neuralgia: A Randomized, Double-Blind, Active Controlled Trial
Scientific Title:Acronym
Effects of PRF-TPN for PHN
Region
| Japan |
Condition
Condition
Postherpetic neuralgia
Classification by specialty
| Dermatology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the outcomes of Pulsed radiofrequency of thoracic paravertebral nerve for postherpetic neuralgia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical rating scale
Global perceived effect
Number needed to treat
Duration of pain relief
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional thoracic paravertebral nerve block
Interventions/Control_2
Pulsed radiofrequency of the thoracic paravertebral nerve
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
1) Postherpetic neuralgia of at least 3 months' duration that could not be controlled with medications
2) Average pain intensity measured on the numerical rating scale with a score >= 3 (from a 0-10 scale)
3) Temporary positive response (100% reduction of pain) to a diagnostic thoracic paravertebral nerve block
4) Symptoms not attributed to another disorder
5) Willingness to comply with the allocated treatment and follow-up measurements
Key exclusion criteria
1) Coagulation abnormalities
2) History of adverse reactions to local anesthetics or contrast medium
3) Patients with psychiatric disease or known serious immune disorders
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichiro Uchida |
Organization
Kurashiki Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1-1 Miwa Kurashiki Okayama
TEL
086-422-0210
ku7877@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichiro Uchida |
Organization
Kurashiki Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1-1 Miwa Kurashiki Okayama
TEL
086-422-0210
Homepage URL
ku7877@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
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
倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | 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
| 2011 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2011 | Year | 02 | Month | 05 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005983
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
