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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034981
Receipt No. R000039890
Scientific Title Medicinal solution distribution of Modified TLIP
Date of disclosure of the study information 2018/11/23
Last modified on 2018/11/23

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Basic information
Public title Medicinal solution distribution of Modified TLIP
Acronym Medicinal solution distribution of Modified TLIP
Scientific Title Medicinal solution distribution of Modified TLIP
Scientific Title:Acronym Medicinal solution distribution of Modified TLIP
Region
Japan

Condition
Condition lumber facet pain
Classification by specialty
Orthopedics Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Medicinal solution distribution of modified TLIP block for patients with lumbar facet syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Just after blocking, chemical distribution in X-ray, CT imaging
Key secondary outcomes Back pain NRS before and just after block

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients considered the lumbar facet joint disease.
2) NTT East Japan Kanto Hospital Patient hospitalized or hospitalized for Pain Clinic.
3) Patients who aged 20 or older at the time of acquisition.
4) Patients who got consent from the person concerned about participation in this study.
Key exclusion criteria 1) Contraceptive use Contraindicated patients
2) Patient judged inappropriate at the discretion of the research doctor.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reon Kobayashi
Organization NTT medical center tokyo
Division name Department of Pain Clinic
Zip code
Address 5-9-22 Higashi Gotanda Shinagawaku Tokyo
TEL 03-3448-6111
Email painclinicinareon@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Reon Kobayashi
Organization NTT medical center tokyo
Division name Department of Pain Clinic
Zip code
Address 5-9-22 Higashi Gotanda Shinagawaku Tokyo
TEL 03-3448-6111
Homepage URL
Email painclinicinareon@gmail.com

Sponsor
Institute NTT medical center tokyo
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 NTT東日本関東病院

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 23 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information After obtaining approval from the ethics committee, after obtaining the research permission from the hospital director until September 31, 2019

Management information
Registered date
2018 Year 11 Month 23 Day
Last modified on
2018 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039890

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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