UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004472 |
|---|---|
| Receipt number | 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 13:56:23 |
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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
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
forpatients2008@gmail.com
Sponsor or person
Institute
Kanto Rosai Hospital, Clinical research center for occupational musculoskeletal disorders
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005351
