UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023228 |
|---|---|
| Receipt number | R000026770 |
| Scientific Title | Pain relieving effect of lumbosacral orthosis after decompression surgery for lumber canal stenosis - prospective randomized controlled study |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2018/08/21 17:38:58 |
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Basic information
Public title
Pain relieving effect of lumbosacral orthosis after decompression surgery for lumber canal stenosis - prospective randomized controlled study
Acronym
Pain relieving effect of lumbosacral orthosis after decompression surgery for lumber canal stenosis - prospective randomized controlled study
Scientific Title
Pain relieving effect of lumbosacral orthosis after decompression surgery for lumber canal stenosis - prospective randomized controlled study
Scientific Title:Acronym
Pain relieving effect of lumbosacral orthosis after decompression surgery for lumber canal stenosis - prospective randomized controlled study
Region
| Japan |
Condition
Condition
Lumber canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using lumbosacral orthosis after decompression surgery for lumber canal stenosis has no evidences, but it has been used customary and the application is different from physicians.
The purpose of this study is evaluating the pain relieving effect by comparing using lumbosacral orthosis with not using it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate the patients JOA Back Pain Evaluation Questionnaire (JOABPEQ) to evaluate low back pain, including several aspects from the patients experience before surgery, post-operative 1 month,3months, 6months,and 12months.
Key secondary outcomes
We investigate visual analogue scale(VAS), hospitalization, and reappointment time.
We investigate the amount of using analgesic drags before post-operative 1 week, and between 1 and 2weeks.
We evaluate radiographs taken before surgery, post-operative 1 month,3months, 6months,and 12months and MRI taken before surgery and post-operative 12 months.
In radiographs, we evaluate adjacent segmental diseases.
In MRI, we evaluate progression of adjacent segmental stenosis and area dimension of back muscles.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervensions:using lumbosacral orthosis for 3months after decompression surgery for lumber canal stenosis.
Interventions/Control_2
Control:not-using lumbosacral orthosis after decompression surgery for lumber canal stenosis.
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
Patients of lumber canal stenosis and performed decompression surgery
Key exclusion criteria
no particular
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Tanaka |
Organization
Okayama university general hospital
Division name
Department of orthopaedic surgery
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama City,Okayama
TEL
086-235-7273
seikei@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Ugawa |
Organization
Okayama university general hospital
Division name
Department of orthopaedic surgery
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama City,Okayama
TEL
086-235-7273
Homepage URL
ryougawa0412@herb.ocn.ne.jp
Sponsor or person
Institute
Department of Orthopaedic surgery, Okayama university general hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic surgery, Okayama university general hospital
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
| 2016 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | 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
| 2016 | Year | 07 | Month | 19 | Day |
Last modified on
| 2018 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026770
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
