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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038408
Receipt No. 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

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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
Email 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
Email y.terajima@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042379

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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