UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019108 |
|---|---|
| Receipt number | R000022079 |
| Scientific Title | CT-epidurography after the fluoroscopic guided epidural injections: comparison between Th1-transforaminal approach and Th1/2-parasagittal interlaminar approach. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/03/30 10:44:53 |
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Basic information
Public title
CT-epidurography after the fluoroscopic guided epidural injections: comparison between Th1-transforaminal approach and Th1/2-parasagittal interlaminar approach.
Acronym
CT-epidurography after the fluoroscopic guided epidural injections: comparison between Th1-transforaminal approach and Th1/2-parasagittal interlaminar approach.
Scientific Title
CT-epidurography after the fluoroscopic guided epidural injections: comparison between Th1-transforaminal approach and Th1/2-parasagittal interlaminar approach.
Scientific Title:Acronym
CT-epidurography after the fluoroscopic guided epidural injections: comparison between Th1-transforaminal approach and Th1/2-parasagittal interlaminar approach.
Region
| Japan |
Condition
Condition
Unilateral upper extreamity pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the contrast dispersion patterns between Th1-transforaminal and Th1/2-parasagittal interlaminar epidural injections.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of CT-epidurography between the two methods concerning as follows, ventral spread,lateral limiting,Th1-root filling,and cephalad/caudad spread.
Key secondary outcomes
Appearance of Horner sign, changes of blood pressure and heart rate, required time of fluoroscopy, complications of procedure including intravascular injection, and improvement of pain score.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Fluoroscopic guided Th1-transforaminal epidural injection: 1.mixture of contrast(0,5ml)and saline(0.5ml)is injected to detemine Th1 radiculography. 2.mixture of contrast(1ml)and 2%-mepivacaine(1ml)is injected. 3.spinal CT(C4-Th4)is performed.
Interventions/Control_2
Fluoroscopic guided Th1/2-parasagittal interlaminar epidural injection:1.mixture of contrast(0,5ml)and saline(0.5ml)is injected to detemine epidurography and loss of resistance, 2.mixture of contrast(1ml)and 2%-mepivacaine(1ml)is injected, 3.spinal CT(C4-Th4)is performed.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.unilateral upper extreamity pain,
2.no abnormalities in the Th1/2 region confirmed by spinal MR images,
3.including disease are cervical disc hernia, cervical spondylosis,thoracic outlet syndrome,zoster associated pain and the other neuropathic pain syndromes of upper extreamities.
Key exclusion criteria
1.apparent cervical spinal stenosis(AP distance of cervical canal<12mm on plain X-ray image),
2.previous history of posterior operation of cervical or upper thoracic spine,
3.anticoagulant therapy, allergy for local anesthetics or contrasts,and the other obstacles for spinal blockade.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | keiji |
| Middle name | |
| Last name | Hashizume |
Organization
Kouseikai Takai Hospital
Division name
Department of Anesthesiology, Pain center
Zip code
632-0006
Address
470-8,Kuranosyu,Tenri city, Nara, Japan
TEL
0743-65-0372
kzume@takai-hp.com
Public contact
Name of contact person
| 1st name | Ryouji |
| Middle name | |
| Last name | Ooba |
Organization
Kouseikai Takai Hospital
Division name
Department of hospital management
Zip code
632-0006
Address
470-8,Kuranosyu,Tenri city, Nara, Japan
TEL
0743-65-0372
Homepage URL
soumu@takai-hp.com
Sponsor or person
Institute
Kouseikai Takai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kouseikai Takai Hospital
Address
470-8,Kuranosyu,Tenri city, Nara, Japa
Tel
0743-65-0372
kzume@takai-hp.com
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
| 2015 | Year | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022079
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