UMIN-CTR Clinical Trial

Basic information
Public title	The countermeasures against non-specific low back pain with our developed exercise program
Acronym	Countermeasures against non-specific LBP
Scientific Title	The countermeasures against non-specific low back pain with our developed exercise program
Scientific Title:Acronym	Countermeasures against non-specific LBP
Region	Japan

Condition
Condition	low back pain
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to analyse the clinical outcome after novel comprehensive exercise program with respect to low back pain (LBP).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The prevalence of LBP(Grade), Numerical Rating Scale(NRS) for LBP [Time Frame: baseline, 3 months]
Key secondary outcomes	Fear Avoidance Beliefs Questionnaire(FABQ), The Kneels STarT Back Screening Tool (SBST), Kessler Psychological Distress (K6) scale, EuroQual(EQ)-5D, Work ability [Time Frame: 3 months]

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The conventional management, and the novel comprehensive exercise program(combined exercises including the trunk rotation) against LBP.
Interventions/Control_2	The conventional management, and the conventional exercise program against LBP.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Workers
Key exclusion criteria	1.Workers having specific low back pain, and who were presently receiving medical treatment. 2.Workes having mental disease, and who were presently receiving medical treatment. 3.Other conditions that resulted in the workers being considered to be ineligible by the researcher.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Fuminari Middle name Last name Asada
Organization	Osaka Rosai Hospital
Division name	Research Center for the Promotion of Health and Employment Support
Zip code	591-8025
Address	3-1179,Nagasone-Cho, Sakai-City, Osaka 591-8025, Japan
TEL	072-255-7520(4255)
Email	f-asada@osakah.johas.go.jp

Public contact
Name of contact person	1st name Fuminari Middle name Last name Asada
Organization	Osaka Rosai Hospital
Division name	Research Center for the Promotion of Health and Employment Support
Zip code	591-8025
Address	3-1179,Nagasone-Cho, Sakai-City, Osaka 591-8025, Japan
TEL	072-255-7520
Homepage URL
Email	f-asada@osakah.johas.go.jp

Sponsor
Institute	Japan Organization of Occupational Health and Safety
Institute
Department

Funding Source
Organization	Japan Organization of Occupational Health and Safety
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	Osaka Rosai Hospital
Address	3-1179, Nagasone-Cho, Sakai-City, Osaka 591-8025, Japan
Tel	072-252-3561
Email	f-asada@osakah.johas.go.jp

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	大阪労災病院（大阪府），神戸ろうさい病院(兵庫県)，和歌山労災病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 21 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 09 Month 01 Day
Date of IRB	2016 Year 03 Month 30 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2018 Year 12 Month 28 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 09 Month 21 Day
Last modified on	2020 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026788