UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006688 |
|---|---|
| Receipt number | R000007906 |
| Scientific Title | Efficacy of the novel comprehensive management program for low back pain in care workers: Part2 |
| Date of disclosure of the study information | 2011/11/08 |
| Last modified on | 2017/08/02 16:33:42 |
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Basic information
Public title
Efficacy of the novel comprehensive management program for low back pain in care workers: Part2
Acronym
Efficacy of the novel comprehensive management program for back pain in care workers: Part2
Scientific Title
Efficacy of the novel comprehensive management program for low back pain in care workers: Part2
Scientific Title:Acronym
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
| 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 Nakaharaku, Kawasaki-shi, Kanagawa-ken
TEL
03-5800-9545
okah-tky@umin.ac.jp
Public contact
Name of contact person
| 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 Nakaharaku, Kawasaki-shi, Kanagawa-ken
TEL
03-5800-9545
Homepage URL
okah-tky@umin.ac.jp
Sponsor or person
Institute
Kanto Rosai Hospital
Institute
Department
Personal name
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)
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
| 2011 | Year | 11 | Month | 08 | 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
| 2011 | Year | 10 | Month | 17 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007906
