UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004472
Receipt No. R000005351
Scientific Title Development of evaluation and management for returning to work in workers on sick leave because of chronic low back pain
Date of disclosure of the study information 2010/10/28
Last modified on 2014/05/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Development of evaluation and management for returning to work in workers on sick leave because of chronic low back pain
Acronym Development of evaluation and management for returning to work in chronic back pain
Scientific Title Development of evaluation and management for returning to work in workers on sick leave because of chronic low back pain
Scientific Title:Acronym Development of evaluation and management for returning to work in chronic back pain
Region
Japan

Condition
Condition workers on sick leave because of chronic low back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop evaluation and management for returning to work in workers on sick leave because of chronic low back pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japan Low back pain Evaluation Questionnaire(JLEQ)
[Time Frame: baseline, 3months]
Key secondary outcomes Numerical rating scale(NRS), SF-36, EuroQol(EQ-5D), Beck Depression Inventory(BDI), Fear Avoidance Beliefs Questionnaire(FABQ), Pain Catastrophizing Scale(PCS), The Brief Job Stress Questionnaires,Utrecht Work Engagement Scale(UWES), Dutch Work Addiction Scale(DUWAS), Salivary Stress Hormone, Brain imaging findings.
[Time Frame: baseline, 3months]

Satisfaction
[Time Frame: 3months]

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 education of low back pain, exercise, cognitive-behavioral therapy(CBT)
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
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria chronic low back pain patients(workers) on sick leave for more than 4 weeks within 6 months
Key exclusion criteria patients who denied to participate in the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ko Matsudaira
Organization Kanto Rosai Hospital
Division name Clinical research center 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 center 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=R000005351

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.