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

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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

Email



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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name