UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020986
Receipt number R000024226
Scientific Title Effect of radiofrequency rhizotomy for cervical facet pain on systemic cytokine levels
Date of disclosure of the study information 2016/03/02
Last modified on 2019/06/12 13:30:23

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Basic information

Public title

Effect of radiofrequency rhizotomy for cervical facet pain on systemic cytokine levels

Acronym

Radiofrequency rhizotomy and systemic cytokines

Scientific Title

Effect of radiofrequency rhizotomy for cervical facet pain on systemic cytokine levels

Scientific Title:Acronym

Radiofrequency rhizotomy and systemic cytokines

Region

Japan


Condition

Condition

cervical facet pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The patients who have cervical facet pain are treated by he radiofrequency cervical facet rhizotomy. This study is aim to prove whether the systemic cytokines are involved in chronic pain and change by the treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between pain score and systemic systemic cytokine levels

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients who are scheduled cervical facet radio frequency rhizotomy for cervical facet pain

Key exclusion criteria

none

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kumiko
Middle name
Last name Tanabe

Organization

Gifu University Graduate School of Medicine

Division name

Anesthesiology and Pain Medicine

Zip code

501-1194

Address

Gifu City Yanagido 1-1

TEL

058-230-6404

Email

kumiko-t@m2.gyao.ne.jp


Public contact

Name of contact person

1st name Kumiko
Middle name
Last name Tanabe

Organization

Gifu University Graduate School of Medicine

Division name

Anesthesiology and Pain Medicine

Zip code

501-1194

Address

Gifu City Yanagido 1-1

TEL

058-230-6404

Homepage URL


Email

kumiko-t@m2.gyao.ne.jp


Sponsor or person

Institute

Gifu University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Gifu University Graduate School of Medicine

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

Gifu University Graduate School of Medicine

Address

Yanagido 1-1, Gifu City

Tel

058-230-6404

Email

kumiko-t@m2.gyao.ne.jp


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

2016 Year 03 Month 02 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

18

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

Terminated

Date of protocol fixation

2016 Year 03 Month 02 Day

Date of IRB

2016 Year 03 Month 02 Day

Anticipated trial start date

2016 Year 03 Month 07 Day

Last follow-up date

2019 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The change of pain score and cytokine levels for all patients who are scheduled cervical facet rhizotomy with inclusion criteria in our hospital.


Management information

Registered date

2016 Year 02 Month 12 Day

Last modified on

2019 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024226


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name