UMIN-CTR Clinical Trial

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
Last 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
Email	t-nishi@konan-wu.ac.jp

Public contact
1st 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
Email	t-nishi@konan-wu.ac.jp

Sponsor
Institute	Konan Woman University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026324