UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022845 |
|---|---|
| Receipt number | R000026324 |
| Scientific Title | Effect of education on pain, psychological factor, and function for lumbar spinal fusion |
| Date of disclosure of the study information | 2016/06/23 |
| Last modified on | 2019/05/07 21:27:24 |
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Basic information
Public title
Effect of education on pain, psychological factor, and function for lumbar spinal fusion
Acronym
Effect of education for lumbar spinal fusion
Scientific Title
Effect of education on pain, psychological factor, and function for lumbar spinal fusion
Scientific Title:Acronym
Effect of education for lumbar spinal fusion
Region
| Japan |
Condition
Condition
Lumber Spinal Stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the evidence for the effectiveness of
neuroscience education for pain, disability, physiological factor, and function after lumber spinal fusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oswestry Disability Index
Key secondary outcomes
Pain intensity, Pain Catastrophizing Scale (PCS) and Tampa Scale of Kinesiophobia (TSK)
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
| Other |
Interventions/Control_1
Neuroscience education
Interventions/Control_2
Behavioral Therapy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria in this study were: age between 20 and 80, lumbar spondylolisthesis and lumbar canal stenosis.
Key exclusion criteria
Patients were not included in the study if they had signs or neurological or psychiatric disorders, or had undergone spinal surgery.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Nishigami |
Organization
Konan Woman University
Division name
Department of Nursing and Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, 658-0001,
TEL
0784133648
t-nishi@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Nishigami |
Organization
Konan Woman University
Division name
Department of Nursing and Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe
TEL
0784133648
Homepage URL
t-nishi@konan-wu.ac.jp
Sponsor or person
Institute
Konan Woman University
Institute
Department
Personal name
Funding Source
Organization
No
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
Address
Tel
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 | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026324
