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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043710
Receipt No. R000048988
Scientific Title Changes of distorted body representation after spine fusion surgery
Date of disclosure of the study information 2021/03/23
Last modified on 2021/03/22

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Basic information
Public title Changes of body imaging after spine surgery
Acronym Changes of body imaging
Scientific Title Changes of distorted body representation after spine fusion surgery
Scientific Title:Acronym Changes of distorted body representation
Region
Japan

Condition
Condition Spine fusion surgery
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Researching about changes of distorted body representation when patients appear chronic low back pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fremental Back Awareness Questionnaire
Key secondary outcomes Neglect like symptoms scale
Visual Analog Scale
Pain Catastrophizing Scale

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Questionnaire survey
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients will schedule for spinal fusion surgery in the thoracolumbar spine
Patients who have back pain for more than 3 months
Key exclusion criteria Medical disorders related to peripheral neuropathy
Dimentia
A diagnosed neurological disorder
The appearance of post-operative delirium
Post-operative complications
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takumi
Middle name
Last name Nakamura
Organization Sanraku Hospital
Division name Orthopeadics Rehabilitation Room
Zip code 101-0062
Address Tokyo, Chiyoda-ku, Kandasurugadai, 2-5
TEL 03-3292-3981
Email nkmrtkm1625aauaaui@icloud.com

Public contact
Name of contact person
1st name Takumi
Middle name
Last name Nakamura
Organization Sanraku Hospital
Division name Orthopeadics Rehabilitation Room
Zip code 101-0062
Address Tokyo, Chiyoda-ku, Kandasurugadai, 2-5
TEL 03-3292-3981
Homepage URL
Email nkmrtkm1625aauaaui@icloud.com

Sponsor
Institute Sanraku Hospital
Institute
Department

Funding Source
Organization Nothing
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 Sanraku Hospital
Address Tokyo, Chiyoda-ku, Kandasurugadai, 2-5
Tel 03-3292-3981
Email nkmrtkm1625aauaaui@icloud.com

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
2021 Year 03 Month 23 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 Open public recruiting
Date of protocol fixation
2020 Year 12 Month 14 Day
Date of IRB
2020 Year 12 Month 24 Day
Anticipated trial start date
2021 Year 01 Month 05 Day
Last follow-up date
2021 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 22 Day
Last modified on
2021 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048988

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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