UMIN-CTR Clinical Trial

Basic information
Public title	Validity and reliability of Japanese version of Pain Neurophysiology Questionnaire in Patients with Non-Specific Chronic Low Back Pain
Acronym	Validity and reliability of Japanese Pain Neurophysiology Questionnaire
Scientific Title	Validity and reliability of Japanese version of Pain Neurophysiology Questionnaire in Patients with Non-Specific Chronic Low Back Pain
Scientific Title:Acronym	Validity and reliability of Japanese Pain Neurophysiology Questionnaire
Region	Japan

Condition
Condition	Non-specific chronic low back pain
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This research aims to investigate validity and reliability of Japanese Pain Neurophysiology Questionnaire (PNQ).
Basic objectives2	Others
Basic objectives -Others	Nil
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PNQ scores
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	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	We are going to recruit patients with non-specific low back pain who visit an orthopaedic clinic regularly, and physiotherapy students at the Tokyo University of Technology.
Key exclusion criteria	Those with red flags or whose first language is not Japanese will be excluded.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koya Mine
Organization	Tokyo University of Technology
Division name	Department of Physical Therapy, School of Health Siences
Zip code
Address	5-23-22, Nishikamata, Ota-ku, Tokyo
TEL	0364242210
Email	mineky@stf.teu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koya Mine
Organization	Tokyo University of Technology
Division name	Department of Physical Therapy, School of Health Sciences
Zip code
Address	5-23-22 Nishi-kamata, Ota ward
TEL	0364242210
Homepage URL
Email	mineky@stf.teu.ac.jp

Sponsor
Institute	Tokyo University of Technology
Institute
Department

Funding Source
Organization	Tokyo University of Technology
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 11 Month 04 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	Terminated
Date of protocol fixation	2017 Year 10 Month 23 Day
Date of IRB	2017 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nil

Management information
Registered date	2017 Year 11 Month 04 Day
Last modified on	2020 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034071