UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012577 |
|---|---|
| Receipt number | R000014712 |
| Scientific Title | Comparison of effects of nerve blocks for acute cervical spondylosis:Randomized parallel group trial |
| Date of disclosure of the study information | 2013/12/14 |
| Last modified on | 2013/12/14 16:23:14 |
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Basic information
Public title
Comparison of effects of nerve blocks for acute cervical spondylosis:Randomized parallel group trial
Acronym
Comparison of effects of nerve blocks for acute cervical spondylosis:Randomized parallel group trial
Scientific Title
Comparison of effects of nerve blocks for acute cervical spondylosis:Randomized parallel group trial
Scientific Title:Acronym
Comparison of effects of nerve blocks for acute cervical spondylosis:Randomized parallel group trial
Region
| Japan |
Condition
Condition
Cervical spondylosis
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare effect of cervical epidural block with that of brachial plexus block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Visual Analogue Scale:VAS
2.Pain Sleep-20
3.Neck Disability Index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
brachial plexus block
Interventions/Control_2
cervical epidural block
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.duration of pain under 3months
2.age over20
3.pain of unilateral upper limb
4.spurling test positive or Jackson test positive
5.visual analogue scale within24hours over 40mm
6.sleep disturbance due to pain
7.already taken NSAIDs ,pregabalin and tramadol
8. can speak Japanese
Key exclusion criteria
1.cervical spondylotic myelopathy
2.vertigo due to cervical spondylosis
3.whiplash injury
4.DM
5.unstable heart disease
6.unstable pulmonary disease
7.cerebral infarction or brain hemorrhage
8.taken anti coagulant agent
9.taken steroid within one month
10.MMT under 3
11.undertaken Brachial plexus block or cervical epidural block within one month
12.doctor's judgment
13. have mental illness
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Enomoto |
Organization
Juntendo University Hospita
Division name
Department of anesthesiology and pain medicine
Zip code
Address
3-1-3 Hongo Bunkyo ward Tokyo Japan
TEL
0338133111
eno99215m@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Enomoto |
Organization
Juntendo university hospital
Division name
Department of anesthesiology and pain medicine
Zip code
Address
3-1-3 Hongo Bunkyo ward Tokyo Japan
TEL
0338133111
Homepage URL
eno99215m@gmai.com
Sponsor or person
Institute
Department anesthesiology and pain medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 14 | Day |
Last modified on
| 2013 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014712
