UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038408 |
|---|---|
| Receipt number | R000042379 |
| Scientific Title | The relationship between the therapeutic effect of Radiofrequency Treatment and thermal sensation threshold in spinal facet disease |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2019/10/28 15:11:34 |
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Basic information
Public title
The relationship between the therapeutic effect of Radiofrequency Treatment and thermal sensation threshold in spinal facet disease
Acronym
The relationship between the therapeutic effect of Radiofrequency Treatment and thermal sensation threshold in spinal facet disease
Scientific Title
The relationship between the therapeutic effect of Radiofrequency Treatment and thermal sensation threshold in spinal facet disease
Scientific Title:Acronym
TERTS
Region
| Japan |
Condition
Condition
Spinal facet disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure the warm pain sensation threshold at the coagulation site when performing Radiofrequency treatment of spinal facet disease, and investigate the relationship with subsequent symptom improvement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2weeks, 1 month, 3 months later Numerous rating scale , Pain Disability Assessment Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
under 60 degree theramal stimulation of medial branch of posterior ramus
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of the patients who consulted for chief complaints of cervical pain and back pain, those who have pain due to facet joint and have their symptoms for more than 3 months
Key exclusion criteria
Those who can not answer iPad questions, who have allergy to local analgesic, pacemaker, past local infection story, tumor, immunodeficiency, and Autoimmune disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ushida |
Organization
Aichi medical University
Division name
Multidisciplinary Pain Center
Zip code
480-1195
Address
Yazakokarimata 1-1, Nagakute, Aichi
TEL
0561-62-5004
ushidat@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Terajima |
Organization
Aichi Medical University
Division name
Multidisciplinary Pain Center
Zip code
480-1195
Address
Yazakokarimata 1-1, Nagakute, Aichi
TEL
0561-52-5004
Homepage URL
y.terajima@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
Yazakokarimata 1-1, Nagakute, Aichi
Tel
0561-62-5004
y.terajima@aichi-med-u.ac.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
| 2019 | Year | 11 | 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
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2019 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042379
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
