UMIN-CTR Clinical Trial

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
Email	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
Email	soumu@takai-hp.com

Sponsor
Institute	Kouseikai Takai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022079