UMIN-CTR Clinical Trial

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	https://doi.org/10.3777/jjsam.69.254
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.2486/indhealth.2021-0186
Number of participants that the trial has enrolled	203
Results	Financial aid (up to 8,000 JPY cashback for four weeks) was provided to office workers who were aware of their status of presenteeism (owing to neck and shoulder stiffness and low back pain) to cover the expenses of acupuncture therapy. The workers received 1.0 (median) sessions of therapy during the four-week observation period, with a cashback of 7,000 (median) JPY. Financial aid for acupuncture therapy may help compensate for losses incurred by enterprises in the form of 14,117 JPY per worker a month.
Results date posted	2022 Year 06 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Office workers who were aware of the effect of presenteeism on their job performance were recruited through online advertisements. The inclusion criteria were as follows: (1) awareness of the decline in one's job performance due to health issues during the past month, (2) being employed and working continuously for three months before and after enrollment in the study (excluding non-regular employees), (3) being engaged in administrative/clerical/technical jobs, and (4) aged between 18 and 65 years old. The exclusion criterion was participation in any other clinical study or trial during the study period.
Participant flow	The participants of this study were recruited from January 26, 2019, to December 28, 2020. Of the 211 participants who met the eligibility criteria and provided informed consent, 103 (including six participants who could not receive the allocated intervention) and 108 were allocated to the intervention and control groups, respectively. Participants were observed for four weeks. After excluding eight dropouts, 203 participants were included in the final analysis.
Adverse events	The adverse events post-intervention included drowsiness (15%), malaise (12%), pain at the therapy-applied site (6%), fatigue (3%), exacerbation of existing symptoms (0.7%), bleeding (0.7%), and hematoma (0.7%). No participants complained of a sick feeling or nausea.
Outcome measures	The relative presenteeism score (a major outcome measure) was significantly higher in the intervention group (median 1.00 [IQR, 0.86-1.00]) than in the control group (median 1.00 [IQR, 0.76-1.00]; effect size [r] = 0.15, P = 0.03). The presenteeism cost per worker in the control group was JPY 60,655 (95% CI: 44,441-76,870), and that in the intervention group was JPY 40,055 (95% CI: 26,114-53,996); cashback per worker of JPY 6,483 (95% CI: 6,080-6,887) and monthly remuneration per worker of 14,117 JPY were expected from the intervention group (cashback).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
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	2020 Year 12 Month 28 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	2022 Year 06 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040245