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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010558
Receipt No. R000012250
Scientific Title Interaction of analgetic effects, radiating pain and radiological contrast material distribution before and after lumbosacral selective nerve root block
Date of disclosure of the study information 2013/04/22
Last modified on 2013/04/22

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Basic information
Public title Interaction of analgetic effects, radiating pain and radiological contrast material distribution before and after lumbosacral selective nerve root block
Acronym Interaction of analgetic effects, radiating pain and radiological contrast material distribution before and after lumbosacral selective nerve root block
Scientific Title Interaction of analgetic effects, radiating pain and radiological contrast material distribution before and after lumbosacral selective nerve root block
Scientific Title:Acronym Interaction of analgetic effects, radiating pain and radiological contrast material distribution before and after lumbosacral selective nerve root block
Region
Japan

Condition
Condition intervertebral disc displacement
Classification by specialty
Orthopedics Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The patients who received lumbosacral selective nerve root block(SNRB) were classified into 3 types based on contrast distribution ,type1 by which a nerve fiber is depicted, type2 by which a nerve sheath is imaged, and type3 to which contrast material spreads to the circumference of a nerve.Relation with the pain reduction after 1.5 hour, radiological finding and the radiating pain at the time of SNRB is verified.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes pain reduction 1.5 hour after SNRB
Key secondary outcomes radiating pain at SNRB

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
81 years-old >=
Gender Male and Female
Key inclusion criteria Patients with intervertebral disc displacement, whose skin consciousness fell and whose pain reduced just after SNRB, and in whom the amount of contrast media used at SNRB was 0.5 ml.
Key exclusion criteria Cauda equina syndrome, local analgesic or steroid anaphylaxis, systemic inflammatory disease, blood coagulation disorder, the bad diabetes of control, psychiatric disorder, malignant disease, cardiac disease, skin trouble of a puncture part, difficult communication, and a backbone postsurgical patient.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoko Chiba
Organization Sendai pain clinic center
Division name Department of Anaesthesiology
Zip code
Address 3-14-1 Shinden Higasi Miyagino-ku Sendai 983-0039 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoko Chiba
Organization Sendai Pain Clinic Center
Division name Department of Anaesthesiology
Zip code
Address 3-14-1 Shinden Higasi Miyagino-ku Sendai 983-0039 Japan
TEL 022-236-1310
Homepage URL
Email sato33150@ktj.biglobe.ne.jp

Sponsor
Institute Sendai Pain Clinic Center
Institute
Department

Funding Source
Organization Sendai Pain Clinic Center
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 仙台ペインクリニック(宮城県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 22 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
The degree of pain reduction after SNRB did not accept a significant difference by 3 group.
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 Completed
Date of protocol fixation
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2012 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The radiating pain at SNRB was more strong in Type1 and 2 than Type 3 .

Management information
Registered date
2013 Year 04 Month 22 Day
Last modified on
2013 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012250

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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