UMIN-CTR Clinical Trial

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

Presenteeism

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

WHO Health and Work Performance Questionnaire (short form) Japanese edition

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Teikyo Heisei University

Institute

Department

Personal name

Organization

The Japan Society for the Promotion of Science ("JSPS")

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Teikyo Heisei University

Address

2-51-4 Higashiikebukuro, Toshima-ku, Tokyo

Tel

03-5843-3111

Email

rec@thu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

20

Day

URL releasing protocol

https://doi.org/10.3777/jjsam.69.254

Publication of results

Published

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

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 related information

Registered date

2018

Year

12

Month

20

Day

Last modified on

2022

Year

06

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040245