UMIN-CTR Clinical Trial

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
Institute	Gifu University Graduate School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024226