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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023228
Receipt No. 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

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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
Email 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
Email ryougawa0412@herb.ocn.ne.jp

Sponsor
Institute Department of Orthopaedic surgery, Okayama university general hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026770

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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