UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Acronym	Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Scientific Title	Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Scientific Title:Acronym	Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Region	Japan

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

Objectives
Narrative objectives1	Currently, health problems of workers are becoming a big social concern. From the past results of the labor health surveys and questionnaire surveys on fatigue, it can be suggested that many workers have feelings of anxiety about health due to fatigue of mind and body, accumulation of fatigue, stress due to work, and various subjective symptoms. Fatigue may lead to a decrease in work efficiency, concentration, and memory ability, while to an increase in mistakes, plausibly causing lifestyle diseases, depression, death from overwork and the like. Effectiveness of acupuncture and moxibustion treatment in improving physical symptoms such as asthenopia, stiff neck/shoulder, general malaise frequently complained by workers with fatigue has also been reported. From the features of acupuncture and moxibustion therapy there is a possibility that it is effective against various symptoms such as fatigue and stress of mind and body, If we can prove the usefulness of acupuncture and moxibustion treatment, it will be meaningful from the viewpoint of health management. In this study, therefore, we examine the usefulness of acupuncture and moxibustion treatment for physical fatigue and mental fatigue in workers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual Analogue Scale
Key secondary outcomes	GHQ-12 Salivary cortisol Saliva amylase Physical symptom score SF-36 Standard Edition WHO Health and Work Performance Questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Other
Interventions/Control_1	Acupuncture and Moxibustion
Interventions/Control_2	Press Needles
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	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Male and Female
Key inclusion criteria	Person with physical fatigue and mental fatigue
Key exclusion criteria	1. Person who underwent consecutive treatments in a psychiatric clinic/hospital, took psychotropic drugs or had such medical history. 2. Person who had a change in living environment including working conditions and medication status or the past one month or less 3. Person with the medical abnormality that may cause fatigue 4. Person in whom a disease or abnormality was discovered and person who had a change in lifestyle or living environment during the study period 5. Female worker in the childcare period 6. Person who presents with a symptom of severe dysmenorrhea or premenstrual syndrome every month 7. Person with menopausal disorder
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomomi Middle name Last name Sakai
Organization	Tokyo Ariake University of Medical and Health Science
Division name	Department of Acupuncture and Moxibustion
Zip code	135-0063
Address	2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL	+08-3-6703-7000
Email	sakai@tau.ac.jp

Public contact
Name of contact person	1st name Arisa Middle name Last name Muko
Organization	Tokyo Ariake University of Medical and Health Sciences Graduate school
Division name	Doctor's Program of Health Sciences
Zip code	135-0063
Address	2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL	+08-3-6703-7000
Homepage URL
Email	arisa71cq@gmail.com

Sponsor
Institute	Tokyo Ariake University of Medical and Health Sciences
Institute
Department

Funding Source
Organization	Tokyo Ariake University of Medical and Health Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Ariake University of Medical and Health Sciences IRB
Address	2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel	+08-3-6703-7000
Email	akiyama@tau.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 09 Month 25 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	Completed
Date of protocol fixation	2018 Year 07 Month 25 Day
Date of IRB	2018 Year 07 Month 26 Day
Anticipated trial start date	2018 Year 09 Month 25 Day
Last follow-up date	2020 Year 03 Month 15 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 09 Month 18 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038969