UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043710 |
|---|---|
| Receipt number | 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 | 2022/11/21 22:07:45 |
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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
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
nkmrtkm1625aauaaui@icloud.com
Sponsor or person
Institute
Sanraku Hospital
Institute
Department
Personal name
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
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
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048988
