UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001555 |
|---|---|
| Receipt number | R000001878 |
| Scientific Title | An exploratory research for a case with peripheral artery disease as a complication of lumbar spinal canal stenosis. |
| Date of disclosure of the study information | 2008/12/05 |
| Last modified on | 2012/01/06 20:50:53 |
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Basic information
Public title
An exploratory research for a case with peripheral artery disease
as a complication of lumbar spinal canal stenosis.
Acronym
LSSP project
Scientific Title
An exploratory research for a case with peripheral artery disease
as a complication of lumbar spinal canal stenosis.
Scientific Title:Acronym
LSSP project
Region
| Japan |
Condition
Condition
lumbar spinal canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An exploratory research for a case with peripheral artery disease as a complication of lumbar spinal canal stenosis.
Basic objectives2
Others
Basic objectives -Others
This study investigates the clinical characteristics of findings in patients with peripheral artery disease as a complication of lumbar spinal canal stenosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JOABPEQ score,SF-36 score,ankle-brachial systolic pressure index
Key secondary outcomes
age,sex,past history,complicating disease,biochemical examination
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A score in the diagnostic support tool for lumbar spinal stenosis is higher than 7 points.
Findings of narrow canal which is associated with symptoms using computed tomography or magnetic resonance imaging.
Key exclusion criteria
1)A patient with consciousness disorder.
2)The presence of cardiac failure, dysfunction of kidneys, respiratory failure, and other critical systemic complications.
3)Participation for this study is hard due to psychiatric disorders or symptoms.
4)A patient with pregnant or suspected of being pregnant, and breast-feeding mother.
5)A patient with myelopathy.
6)The presence of the previous surgery of lumbar spine.
7)A patient who visits for a second opinion.
Target sample size
810
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Konno |
Organization
Fukushima medical university school of medicine
Division name
Department of orthopaedic surgery
Zip code
Address
1-Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan
TEL
024-545-1276
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Konno |
Organization
Fukushima medical university school of medicine
Division name
Department of orthopaedic surgery
Zip code
Address
1-Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan
TEL
024-545-1276
Homepage URL
fortho@fmu.ac.jp
Sponsor or person
Institute
Fukushima medical university school of medicine
Institute
Department
Personal name
Funding Source
Organization
The japanese society for spine surgery and related reseach
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
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
| 2008 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
cohort study
Management information
Registered date
| 2008 | Year | 12 | Month | 05 | Day |
Last modified on
| 2012 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001878
