UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015119 |
|---|---|
| Receipt number | R000017589 |
| Scientific Title | Examination of association between twitch, imaging view and the effect in lumbar nerve root block with pulsed radiofrequency |
| Date of disclosure of the study information | 2014/09/15 |
| Last modified on | 2015/03/11 11:26:33 |
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Basic information
Public title
Examination of association between twitch, imaging view and the effect in lumbar nerve root block with pulsed radiofrequency
Acronym
Examination of association between twitch, imaging view and the effect in lumbar nerve root block with pulsed radiofrequency
Scientific Title
Examination of association between twitch, imaging view and the effect in lumbar nerve root block with pulsed radiofrequency
Scientific Title:Acronym
Examination of association between twitch, imaging view and the effect in lumbar nerve root block with pulsed radiofrequency
Region
| Japan |
Condition
Condition
low back and lower extremity pain
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of association between twitch, imaging view and the effect in lumbar nerve root block with pulsed radiofrequency for low back and lower extremity pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Twitch incidence by contrast imaging views in lumbar nerve root block with pulsed radiofrequency
Key secondary outcomes
pain decreasing degree by the presence or absence of twitch
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
lumbar nerve root block with pulsed radiofrequency
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
patients with low back pain with or without lower extremity pain
Age: 20 years or older
Patients capable of proper assessment
Moderately troublesome pain
Key exclusion criteria
cauda equina syndrome
allergy to local anaesthetics and/or steroids
Serious chronic diseases such as inflammatory disease, blood coagulation disorder, severe diabetes, psychiatric disease, malignant disease, cardiac failure, skin troubles of puncture site
communication difficulty
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoko Chiba |
Organization
Sendai Pain Clinic Center
Division name
Anesthesiology
Zip code
Address
3-4-11, Shindenhigashi, Miyagino-ku Sendai, Miyagi, Japan
TEL
022-236-1310
info@itamitoru.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Chiba |
Organization
Sendai Pain Clinic Center
Division name
Anesthesiology
Zip code
Address
3-4-11, Shindenhigashi, Miyagino-ku Sendai, Miyagi, Japan
TEL
022-236-1310
Homepage URL
sato33150@ktj.biglobe.ne.jp
Sponsor or person
Institute
Sendai Pain Clinic Center
Institute
Department
Personal name
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 11 | Day |
Last modified on
| 2015 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017589
| Research Plan | |
|---|---|
| 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 |
