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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001565
Receipt No. R000001840
Scientific Title BS-POP validation study
Date of disclosure of the study information 2008/12/11
Last modified on 2010/06/18

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Basic information
Public title BS-POP validation study
Acronym BS-POP validation study
Scientific Title BS-POP validation study
Scientific Title:Acronym BS-POP validation study
Region
Japan

Condition
Condition Chronic low back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 prove the effectiveness of BS-POP
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BS-POP
MMPI
POMS
SF-36
RDQ
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)A patient older than 20 years old at the agreement acquisition.
(2)VAS is longer than 40mm at the baseline observation.
(3)A duration of low back pain is more than three months.
(4)Major area of low back pain is lower than 12th thoracic vertebra.
(5)An adequate patients , who is decided by a doctor , for participation of this study.
(6)A patient conform a treatment plan and a planned hospital visit,and has vilition and ability for clinical inspections.
(7)A patient who consents and document to enroll this study before starting investigation.
Key exclusion criteria (1)The presence of rheumatoid arthritis, spondyloarthropathy (e.g.,ankylosing spondylitis, psoriasis-related joint pain) with negative serum reaction, metastasis of tumors, Behcets disease, fibromyalgia, tumor or infection of the spinal cord or intervertebral disc , and a past history of other diseases of the sharp pain
(2)The presence of low back pain due to trauma within 6 months after registration(e.g.,vertebral fracture,pseudarthrosis,spondylarthropathy due to trauma).
(3)The presence of low back pain due to internal organs diseases.
(4)The presence of malignant tumor , or the past history of the malignant tumor.
(A patient who underwent surgical resection of malignant tumor or no recurrence cancer more than 5 years after registration.)
(5)A past history abuse of alchol , analgesic , and drugs.
(6)Inadequate patient,who is decided by a doctor,for participation or execution.
(7)Having relevance to traffic or occupational accidents.
(8)The past history of spinal surgery within six months.
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shin-ichi konno
Organization fukushima medical university
Division name orthopedics
Zip code
Address 1, Hikarigaoka, Fukushima-shi, Fukushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization fukushima medical university
Division name orthopedics
Zip code
Address
TEL
Homepage URL
Email fortho@fmu.ac.jp

Sponsor
Institute SGSP
Institute
Department

Funding Source
Organization fukushima medical university orthopedics
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 11 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 11 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 10 Month 01 Day
Date trial data considered complete
2009 Year 10 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information Observation ofrelation between BS-POP and MMPI

Management information
Registered date
2008 Year 12 Month 11 Day
Last modified on
2010 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001840

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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