UMIN-CTR Clinical Trial

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
Email	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
Email	ku7877@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005983