UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019467 |
|---|---|
| Receipt number | R000021843 |
| Scientific Title | Impact of psychological and physical factors before surgery on outcomes at postoperative among the patients with lumbar disease |
| Date of disclosure of the study information | 2015/10/23 |
| Last modified on | 2019/04/25 12:27:37 |
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Basic information
Public title
Impact of psychological and physical factors before surgery on outcomes at postoperative among the patients with lumbar disease
Acronym
Impact of psychological and physical factors before surgery on outcomes at postoperative among the patients with lumbar disease
Scientific Title
Impact of psychological and physical factors before surgery on outcomes at postoperative among the patients with lumbar disease
Scientific Title:Acronym
Impact of psychological and physical factors before surgery on outcomes at postoperative among the patients with lumbar disease
Region
| Japan |
Condition
Condition
degenerative spinal disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the impact of psychological and physical factors before surgery on outcomes at postoperative among the patients with lumbar disease
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
falling
pain
satisfaction
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diagnosis of degenerative spinal disease with compression of the neural elements
an indication for decompression surgery
willingness to complete this study follow-ups
a good understanding of written and spoken Japanese.
Key exclusion criteria
The surgical adaptation to trauma
previous spinal fusion
severe medical problems
Judgment of researchers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hagino |
Organization
Tottori University
Division name
School of Health Science, Faculty of Medicine
Zip code
683-8504
Address
Nishicho 86, Yonago, Tottori
TEL
0859-38-6308
hagino@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Wada |
Organization
Tottori University Hospital
Division name
Rehabilitation Division
Zip code
683-8504
Address
Nishicho 36-1, Yonago, Tottori
TEL
0859-38-6862
Homepage URL
t.wada@med.tottori-u.ac.jp
Sponsor or person
Institute
School of Health Science, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
School of Health Science, Faculty of Medicine, Tottori University
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
Certified Review Board, Tottori University Hospital
Address
Nishicho 36-1, Yonago, Tottori
Tel
0859-38-7021
cert.office@ml.med.tottori-u.ac.jp
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
| 2015 | Year | 10 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Cohort study
Recruitment method:patient matched inclusion criteria after the October 2015
Outcome:Pain,Satisfaction of surgery,Psychological factors,motor function
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021843
| Research Plan | |
|---|---|
| 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 |
