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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035321
Receipt No. R000040245
Scientific Title Verification of effectiveness of an acupuncture treatment program for improving labor productivity
Date of disclosure of the study information 2018/12/20
Last modified on 2019/06/21

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Basic information
Public title Verification of effectiveness of an acupuncture treatment program for improving labor productivity
Acronym Verification of the utility of acupuncture treatment subsidies for presenteeism of office workers
Scientific Title Verification of effectiveness of an acupuncture treatment program for improving labor productivity
Scientific Title:Acronym Verification of the utility of acupuncture treatment subsidies for presenteeism of office workers
Region
Japan

Condition
Condition Presenteeism
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the early 2000s, the presenteeism concept, which means that office workers consider to themselves, "I am not so ill as to take a day off from work, but I feel somehow unwell and cannot work as efficiently as I thought," began to be recognized as decreasing labor productivity and inflict large losses to companies. For one thing, the total economic loss due to various symptoms, such as shoulder stiffness and lumbar pain, in many workers was found to far exceed the loss due to their absences from work because of illnesses and medical costs. This study aimed to verify that acupuncture treatment subsidies are useful as a comprehensive measure for industrial health management/health and productivity management and to clarify that such subsidies would contribute to the maintenance and improvement of the public health and welfare.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes WHO Health and Work Performance Questionnaire (short form) Japanese edition
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver Other
Interventions/Control_1 In addition to taking usual arbitrary measures, those workers who have received acupuncture treatment at offices of publicly recruited acupuncturists during observation period can receive a maximum of 8000 yen subsidy (cashback) by submitting a receipt of the treatment after the observation period.
Interventions/Control_2 A control group that may optionally implement measures against ordinary presenteeism recommended by the offices.
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1)Those who consider to themselves, "I am not so ill as to take a day off from work, but I feel somehow unwell and cannot work as efficiently as I thought," due to some sort of poor health, such as shoulder stiffness and lumbar pain, during the past one month;
(2)Those who have been continuously employed and working for a certain period of time;
(3)Those whose main job is other than production (on-site or transportation, manufacturing, etc.);
(4)Those who can come to the study site (Toshima Ward, Tokyo) twice or so during the study period;
Key exclusion criteria (1)Those who are participating (or plan to participate) in other studies or trials at the same time; and
(2)Those who deemed inappropriate for this study by the investigator.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name Shogo
Middle name
Last name Miyazaki
Organization Teikyo Heisei University
Division name Faculty of Health Care
Zip code 1708445
Address 2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL 03-5843-3111
Email s.miyazaki@thu.ac.jp

Public contact
Name of contact person
1st name Shogo
Middle name
Last name Miyazaki
Organization Teikyo Heisei University
Division name Faculty of Health Care
Zip code 1708445
Address 2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL 03-5843-3111
Homepage URL
Email s.miyazaki@thu.ac.jp

Sponsor
Institute Teikyo Heisei University
Institute
Department

Funding Source
Organization The Japan Society for the Promotion of Science ("JSPS")
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 Teikyo Heisei University
Address 2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
Tel 03-5843-3111
Email rec@thu.ac.jp

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
2018 Year 12 Month 20 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
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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 20 Day
Date of IRB
2018 Year 09 Month 20 Day
Anticipated trial start date
2019 Year 01 Month 26 Day
Last follow-up date
2022 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
2018 Year 12 Month 20 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040245

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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