UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028614 |
|---|---|
| Receipt number | R000032750 |
| Scientific Title | Relation between leg pain at rest and spinal nerve edema in lumbar foraminal stenosis |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2017/08/09 20:20:31 |
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Basic information
Public title
Relation between leg pain at rest and spinal nerve edema in lumbar foraminal stenosis
Acronym
Relation between leg pain at rest and spinal nerve edema
Scientific Title
Relation between leg pain at rest and spinal nerve edema in lumbar foraminal stenosis
Scientific Title:Acronym
Relation between leg pain at rest and spinal nerve edema
Region
| Japan |
Condition
Condition
lumbar foraminal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate accurate diagnosing support tool of symptomatic foraminal stenosis, in this study, we prospectively investigated clinical findings and MRM findings in symptomatic foraminal stenosis patients, focusing on the association between leg pain at rest and spinal nerve edema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between the VAS for leg pain at rest and the spinal nerve edema ratio in symptomatic foraminal stenosis
Key secondary outcomes
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
| Other |
Interventions/Control_1
radiological images, spinal nerve block
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed foraminal stenosis on MRI with chief complaint of unilateral leg pain which temporally disappeared in response to a selective nerve root block were surveyed.
Key exclusion criteria
Together with intra-spinal canal stenosis on MRI.
Evident disc hernia mass on MRI.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamada Katsutaka |
Organization
Yokohama City University
Division name
Orthopaedics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2655
katsutaka@af.em-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamada Katsutaka |
Organization
Yokohama City University
Division name
Orthopaedics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2655
Homepage URL
katsutaka@af.em-net.ne.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2017 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032750
