UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pain relieving effect of lumbosacral orthosis after decompression surgery for lumber canal stenosis - prospective randomized controlled study
Title of the study (Brief title)	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	Masato Tanaka
Organization	Okayama university general hospital
Division name	Department of orthopaedic surgery
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	Ryo Ugawa
Organization	Okayama university general hospital
Division name	Department of orthopaedic surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 07 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026770