UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the feasibility of acupuncture and moxibustion treatment on short-term intensive exercise program in care prevention
Acronym	Investigation of the feasibility of acupuncture and moxibustion treatment on short-term intensive exercise program in care prevention
Scientific Title	Investigation of the feasibility of acupuncture and moxibustion treatment on short-term intensive exercise program in care prevention
Scientific Title:Acronym	Investigation of the feasibility of acupuncture and moxibustion treatment on short-term intensive exercise program in care prevention
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study was to explore the feasibility of combining acupuncture and moxibustion treatment in a short-term intensive exercise program for care prevention. The subjects were residents of the town of Yanaizu, Fukushima Prefecture, aged 65 years or older, who were not certified for long-term care. This study will examine the safety and feasibility of acupuncture and moxibustion treatment in combination with exercise therapy for long-term care prevention, and will also explore the possibility of introducing this treatment into future long-term care projects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the frequency of adverse events with respect to safety in the practice of acupuncture and moxibustion. Acupuncture treatments will be performed once a week for a total of 14 weeks, so the evaluation will be conducted in conjunction with each acupuncture treatment.
Key secondary outcomes	1. Assess the subject's pain using a visual analogue scale. 2. Quality of Life (QOL) assessment: QOL is assessed using the SF-8 (MOS 8-Item Short-Form Health Survey), with scores calculated from the SF-8. Secondary outcomes will be assessed at baseline (week 1) and at 16 weeks.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Acupuncture treatment to the pain site complained by the subject. Acupuncture treatments will be performed once a week for a total of 14 treatments.
Interventions/Control_2
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	65 years-old <=
Age-upper limit	120 years-old >
Gender	Male and Female
Key inclusion criteria	1 Persons 65 years of age or older. 2 Those who have not received nursing care certification. 3 Gender is not a factor. 4 Subjects with chronic pain and VAS of 20mm or more.
Key exclusion criteria	1 Research subjects with poorly controlled cancer. 2 Research subjects who have difficulty communicating due to mental disorders. 3 Research subjects with allergies to metals. 4 Research subjects who do not have pain. 5 Subjects with chronic pain but with a VAS of less than 20mm.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tadamichi Middle name Last name Mitsuma
Organization	Aizu Medical Center, Fukushima Medical University
Division name	Department of Kampo Medicine
Zip code	969-3492
Address	21-2 Maeda, Kawahigashi, Aizuwakamatsu city Fukushima
TEL	0242752100
Email	tmitsuma@fmu.ac.jp

Public contact
Name of contact person	1st name Masao Middle name Last name Suzuki
Organization	Aizu Medical Center, Fukushima Medical University
Division name	Department of Kampo Medical Research Institute
Zip code	969-3492
Address	21-2 Maeda, Kawahigashi, Aizuwakamatsu city Fukushima
TEL	0242752100
Homepage URL
Email	masuzuki@fmu.ac.jp

Sponsor
Institute	Aizu Medical Center, Fukushima Medical University
Institute
Department

Funding Source
Organization	Fukushima Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukushima Medical University School of Medicine
Address	1-Hikarigaoka, Fukushima
Tel	024-547-1041
Email	fmucrb@fmu.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	社会福祉法人両沼厚生会　柳津町高齢者生活福祉センター（福島県）

Other administrative information
Date of disclosure of the study information	2022 Year 10 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	Enrolling by invitation
Date of protocol fixation	2022 Year 07 Month 31 Day
Date of IRB	2022 Year 10 Month 03 Day
Anticipated trial start date	2022 Year 11 Month 05 Day
Last follow-up date	2024 Year 01 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	2022 Year 10 Month 25 Day
Last modified on	2022 Year 10 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056153