UMIN-CTR Clinical Trial

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
Last 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
Email	neuromicky@hotmail.com

Public contact
1st 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
Email	neuromicky@hotmail.com

Sponsor
Institute	Aichi Medical University
Institute
Department

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