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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020979
Receipt No. R000024013
Scientific Title Cervical Radiculopathy: Diagnostic Assessment via Ultrasonography.
Date of disclosure of the study information 2016/02/12
Last modified on 2019/05/28

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Basic information
Public title Cervical Radiculopathy: Diagnostic Assessment via Ultrasonography.
Acronym Cervical Radiculopathy: Diagnostic Assessment via Ultrasonography.
Scientific Title Cervical Radiculopathy: Diagnostic Assessment via Ultrasonography.
Scientific Title:Acronym Cervical Radiculopathy: Diagnostic Assessment via Ultrasonography.
Region
Japan

Condition
Condition Patients with suspicious cervical radiculopathy.
Classification by specialty
Orthopedics Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the diagnostic cut-off value (sensitivity and specificity) of cross-sectional area of cervical nerve root with the cervical radiculopahty.
Basic objectives2 Others
Basic objectives -Others To examine the reliability sensitivity and specificity) of diagnostic ultrasonography for cervical radiculopathy.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The cross-sectional area(CSA) of cervical radiculopathy subject (CR group) and non cervical radiculopathy subjects (non-CR group) at he same cevical nerve level were compared.
Key secondary outcomes To examine the relationship between Neck Disability Index (NDI) and Visual Analogue Scale (VAS) and the enlargement of the CSAs.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Cervical nerve root ultrasonography is performed one time for the patients with suspicious cervical radiculopathy before various treatments by ultrasonic technicians, who were unaware of the results of cervical MRI .
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 were included who suffer from unilateral radicular pain to an arm, sensory disturbance, and/or motor weakness at an upper limb with suspicious cervical radiculopathy. We divide 2 groups by using cervical MRI (c-MRI) as a reference standard. First, in cevical radiculopathy group c-MRI indicated the cerivcial nerve is compressed by disc herniation or osteophyte. Second, in non cervical radicuropathy the finding was negative on c-MRI.
Key exclusion criteria Patients with neck pain only, trauma case, severe diabetes, severe renal disfunction, collagen disease, or neuromuscular disease.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Mikinobu
Middle name
Last name TAKEUCHI
Organization Aichi Medical University
Division name Spine Center
Zip code 480-1195
Address 1-1, Karimata, Yazako, Nagakute City, Aichi
TEL 0561-62-3311
Email 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
Zip code 480-1195
Address 1-1, Karimata, Yazako, Nagakute City, Aichi
TEL 0561-62-3311
Homepage URL
Email neuromicky@hotmail.com

Sponsor
Institute MIKINOBU (First name) TAKEUCHI (last name)
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
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 neuromicky@hotmail.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
2016 Year 02 Month 12 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
2015 Year 11 Month 02 Day
Date of IRB
2016 Year 02 Month 12 Day
Anticipated trial start date
2016 Year 02 Month 12 Day
Last follow-up date
2018 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 11 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=R000024013

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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