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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004473
Receipt No. R000005350
Scientific Title Efficacy of the novel comprehensive management program for low back pain in care workers
Date of disclosure of the study information 2010/10/28
Last modified on 2014/05/15

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Basic information
Public title Efficacy of the novel comprehensive management program for low back pain in care workers
Acronym Efficacy of the novel comprehensive management program for back pain in care workers
Scientific Title Efficacy of the novel comprehensive management program for low back pain in care workers
Scientific Title:Acronym Efficacy of the novel comprehensive management program for back pain in care workers
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 Japan Low back pain Evaluation Questionnaire(JLEQ), modified Von Korff's graded chronic pain scale(modified GCPS)
[Time Frame: baseline, 3, 6, 12months]
Key secondary outcomes Numerical rating scale(NRS), EuroQol(EQ-5D), SF-36(Mental Health), Fear Avoidance Beliefs Questionnaire(FABQ)
(physical activity),The Brief Job Stress Questionnaire, Utrecht Work Engagement Scale(UWES)
[Time Frame: baseline, 3, 6, 12months]

Satisfaction [Time Frame: 3,6,12months]

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
Medicine Device,equipment 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 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ko Matsudaira
Organization Kanto Rosai Hospital
Division name Clinical research centers for occupational musculoskeletal disorders
Zip code
Address 1-1 Sumiyoshi-cho, Kizuki Nakahara-ku, Kawasaki-shi, Kanagawa-ken
TEL 044-411-3169
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Yamada
Organization University of Tokyo
Division name Department of Orthopaedic Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL 03-3812-2111
Homepage URL
Email forpatients2008@gmail.com

Sponsor
Institute Kanto Rosai Hospital, Clinical research centers for occupational musculoskeletal disorders
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare(Japan)
Organization
Division
Category of Funding 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
2010 Year 10 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 28 Day
Last modified on
2014 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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