UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020979 |
|---|---|
| Receipt number | 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 10:38:21 |
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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
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
neuromicky@hotmail.com
Sponsor or person
Institute
MIKINOBU (First name) TAKEUCHI (last name)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024013
