UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention of low back pain in nurses.
Title of the study (Brief title)	12ROSAI-Study
Region	Japan

Condition
Condition	Low back pain
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A high prevalence of low back pain has persisted over the years among nurses. This study investigates the effectiveness and feasibility of simple exercise intervention and education for nurses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement in subjective evaluations before and after the interventions (NRS:Numerical Rating Scale).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Simple exercise
Interventions/Control_2	Simple exercise + education
Interventions/Control_3	Control
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	Nurses in 12 ROSAI hospitals.
Key exclusion criteria	Pregnancy Lumbar Spinal Stenosis
Target sample size	5000

Research contact person
Name of lead principal investigator	Ko Matsudaira
Organization	22nd Century Medical & Research Center, Faculty of Medicine, University of Tokyo, Tokyo, Japan
Division name	Department of Medical Research and Management for Musculoskeletal Pain
Address	7-3-1, Bunkyo-ku, Hongo, Tokyo
TEL	03-5800-9545
Email	kohart801@yahoo.co.jp

Public contact
Name of contact person	Kenichiro Takano
Organization	Japan Labour Health and Welfare Organization KANSAI ROSAI Hospital
Division name	Center for Preventive Medicine
Address	3-1-69 Inabaso, Amagasaki
TEL	06-6416-1221
Homepage URL
Email	stop@kanrou.net

Sponsor
Institute	22nd Century Medical & Research Center, Faculty of Medicine, University of Tokyo, Tokyo, Japan
Institute
Department

Funding Source
Organization	MHLW(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 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

Management information
Registered date	2015 Year 06 Month 25 Day
Last modified on	2017 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020933