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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001555
Receipt No. 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

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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
Email

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
Email fortho@fmu.ac.jp

Sponsor
Institute Fukushima medical university school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001878

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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