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
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
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
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
