UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006054 |
|---|---|
| Receipt number | R000007165 |
| Scientific Title | Effects of Pulsed Radiofrequency Treatment of the Supraorbital Nerve for Postherpetic Neuralgia: A Prospective, Randomized, Open, Blinded-Endpoint Trial |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2011/09/06 17:31:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Pulsed Radiofrequency Treatment of the Supraorbital Nerve for Postherpetic Neuralgia: A Prospective, Randomized, Open, Blinded-Endpoint Trial
Acronym
Effects of PRF-SON for PHN
Scientific Title
Effects of Pulsed Radiofrequency Treatment of the Supraorbital Nerve for Postherpetic Neuralgia: A Prospective, Randomized, Open, Blinded-Endpoint Trial
Scientific Title:Acronym
Effects of PRF-SON 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 supraorbital nerve for postherpetic neuralgia involving the first division of the trigeminal nerve.
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
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional supraorbital nerve block
Interventions/Control_2
Pulsed radiofrequency of the supraorbital 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 (>50% pain reduction) to a diagnostic supraorbital 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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kurashiki Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
TEL
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 | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 07 | Month | 27 | Day |
Last modified on
| 2011 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007165
