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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019467
Receipt No. 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

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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
Email 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
Email t.wada@med.tottori-u.ac.jp

Sponsor
Institute School of Health Science, Faculty of Medicine, Tottori University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021843

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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