UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011334 |
|---|---|
| Receipt number | R000013281 |
| Scientific Title | The morphological examination of the cervical nerve root in cervical spondylosis patients by an ultrasound. |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2019/05/28 10:34:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The morphological examination of the cervical nerve root in cervical spondylosis patients by an ultrasound.
Acronym
cervical nerve root examined by an ultrasonic examination.
Scientific Title
The morphological examination of the cervical nerve root in cervical spondylosis patients by an ultrasound.
Scientific Title:Acronym
cervical nerve root examined by an ultrasonic examination.
Region
| Japan |
Condition
Condition
Patients with cervical spondylosis
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether it is different in the morphology of the cervical nerve root with cervical myelopathy, cervical radiculopahty, or cervical amyotrophy by using a ultrasound.
Basic objectives2
Others
Basic objectives -Others
We investigate that it is different in the morphology of the cervical nerve root between cervical spondylosis and normal human by using a ultrasound.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A diameter, a transverse diameter, and cross-sectional area of C5, C6 and C7 nerve root with cervical spondylosis are compared with that of normal human.
Key secondary outcomes
Initial data with a diameter, a transverse diameter, and cross-sectional area at C5, C6 and C7 nerve root are compared with one and two year after any treatment respectively.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as cervical spondylosis by neurological, some radiological and/or physiological findings.
Key exclusion criteria
severe liver dysfunction, severe renal dysfunction, severe diabetic, collagen disease, or neuromuscular disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mikinobu |
| Middle name | |
| Last name | Mikinobu |
Organization
Aichi Medical University
Division name
Spine Center, Neurological Surgery
Zip code
480-1195
Address
1-1, Karimata Yazako Nagakute City Aichi
TEL
0561-62-3311
neuromicky@hotmail.com
Public contact
Name of contact person
| 1st name | Mikinobu |
| Middle name | |
| Last name | Takeuchi |
Organization
Aichi Medical University
Division name
Spine Center, Neurological Surgery
Zip code
480-1195
Address
1-1, Karimata Yazako Nagakute City Aichi
TEL
0561-62-3311
Homepage URL
neuromicky@hotmail.com
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Aichi Medical University
Address
1-1, Karimata, yazako, Nagakute City, Japan
Tel
0561-62-3311
syomu@aichi-med-u.ac.jp
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
白山外科クリニック（愛知県）、あさい病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | 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
30
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
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013281
