UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Motion analysis of patients with low back pain by use of accelerometer and gyroscope
Title of the study (Brief title)	Motion analysis of patients with low back pain by use of accelerometer and gyroscope
Region	Japan

Condition
Condition	healthy subject patients with low back pain
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	validity and reliability of accelerometer and gyroscope motion analysis of patients with low back pain
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	angular velocity
Key secondary outcomes	acceleration range of motion

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	10 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy subject have subjective symptom of low back pain more than three months
Key exclusion criteria	a person with orthopedic diseases
Target sample size	36

Research contact person
Name of lead principal investigator	Kazuya Umeyama
Organization	Graduate School of Health Science, Kio University
Division name	Division of Health Science
Address	4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara
TEL	0745541601
Email	b5108949@kio.ac.jp

Public contact
Name of contact person	Kazuya Umeyama
Organization	Graduate School of Health Science, Kio University
Division name	Division of Health Science
Address	4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara
TEL	0745541601
Homepage URL
Email	b5108949@kio.ac.jp

Sponsor
Institute	Kio university
Institute
Department

Funding Source
Organization	Kio university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 08 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 20 Day
Anticipated trial start date	2016 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Nothing especially

Management information
Registered date	2016 Year 08 Month 13 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027197