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Recruitment status Completed
Unique ID issued by UMIN UMIN000011334
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Mikinobu
Organization Aichi Medical University
Division name Spine Center, Neurological Surgery
Zip code
Address 1-1, Karimata Yazako Nagakute City Aichi
TEL 0561-62-3311
Email neuromicky@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takeuchi
Organization Aichi Medical University
Division name Spine Center, Neurological Surgery
Zip code
Address 1-1, Karimata Yazako Nagakute City Aichi
TEL 0561-62-3311
Homepage URL
Email neuromicky@hotmail.com

Sponsor
Institute Aichi Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Address
Tel
Email

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013281


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