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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001836
Receipt No. R000002212
Scientific Title A Study of low back pain prevention and alleviation for female care givers : multicenter-randomized controlled trial
Date of disclosure of the study information 2009/04/01
Last modified on 2010/04/14

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Basic information
Public title A Study of low back pain prevention and alleviation for female care givers : multicenter-randomized controlled trial
Acronym A Study of low back pain prevention for female care givers
Scientific Title A Study of low back pain prevention and alleviation for female care givers : multicenter-randomized controlled trial
Scientific Title:Acronym A Study of low back pain prevention for female care givers
Region
Japan

Condition
Condition female care givers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of excercise program for low back pain prevention and alleviation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain, depression
Key secondary outcomes Finger-Floor-Distance, Fatigue self-check list

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 An orthopedist has a lecture once, and an expert introduces low back pain alleviation excercise once. Participants takes the excercise into practice before their daily work.
Interventions/Control_2 just distribute leaflet.
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
21 years-old <=
Age-upper limit
59 years-old >=
Gender Female
Key inclusion criteria female care givers
Key exclusion criteria having a disease
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroharu Kamioka
Organization Tokyo University of Agriculture
Division name Faculty of Regional Environmental Science
Zip code
Address Sakuragaoka 1-1-1, Setagaya-ku, Toukyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo University of Agriculture
Division name Faculty of Regional Environmental Science
Zip code
Address Sakuragaoka 1-1-1, Setagaya-ku, Toukyo
TEL 03-5477-2587
Homepage URL
Email

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

Funding Source
Organization Akaeda Medical Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 23 (52%) participants withdrew by 12 weeks. Regarding the reasons for withdrawal, 22 participants were resigned, and one took a leave of absence due to lumbago aggravation. Adherence to the stretching exercises was 2.3 (SD,1.3) times per week. No significant difference was seen for all outcome measurements. The high adherence group (3 times and more per week) did not have a change in the VAS, but the low adherence group (less than3 times per week) and control group showed a tendency towards aggravation (p=0.068).
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 Completed
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 01 Day
Last modified on
2010 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002212

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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