UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the novel comprehensive management program for low back pain in care workers: Part2
Title of the study (Brief title)	Efficacy of the novel comprehensive management program for back pain in care workers: Part2
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 functional and clinical outocome after the novel comprehensive management program of care workers with respect to the low back pain during the study period.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	modified Von Korff's graded chronic pain scale (modified GCPS) [Time Frame: baseline, 12months]
Key secondary outcomes	Oswestry Disability Index(ODI), SF-36(Mental Health), Fear Avoidance Beliefs Questionnaire (FABQ)(physical activity),The Brief Job Stress Questionnaire, Utrecht Work Engagement Scale(UWES),Satisfaction [Time Frame: baseline,12months]

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Behavioral: Management based on the novel comprehensive program for low back pain. Trained orthopedist is responsible for the program.
Interventions/Control_2	Behavioral: Self-management with the evidence-based booklet.
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	18 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Care workers
Key exclusion criteria	Patients who denied to participate in the study
Target sample size	140

Research contact person
Name of lead principal investigator	Ko Matsudaira
Organization	Kanto Rosai Hospital
Division name	Clinical research centers for occupational musculoskeletal disorders
Address	1-1 Sumiyoshi-cho, Kizuki Nakaharaku, Kawasaki-shi, Kanagawa-ken
TEL	03-5800-9545
Email	okah-tky@umin.ac.jp

Public contact
Name of contact person	Ko Matsudaira
Organization	Kanto Rosai Hospital
Division name	Clinical research centers for occupational musculoskeletal disorders
Address	1-1 Sumiyoshi-cho, Kizuki Nakaharaku, Kawasaki-shi, Kanagawa-ken
TEL	03-5800-9545
Homepage URL
Email	okah-tky@umin.ac.jp

Sponsor
Institute	Kanto Rosai Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
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	2011 Year 11 Month 08 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 10 Month 17 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 08 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=R000007906