UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001565 |
|---|---|
| Receipt number | R000001840 |
| Scientific Title | BS-POP validation study |
| Date of disclosure of the study information | 2008/12/11 |
| Last modified on | 2010/06/18 09:46:05 |
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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
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
fortho@fmu.ac.jp
Sponsor or person
Institute
SGSP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001840
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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