UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049317 |
|---|---|
| Receipt number | R000056153 |
| Scientific Title | Investigation of the feasibility of acupuncture and moxibustion treatment on short-term intensive exercise program in care prevention |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2022/10/25 19:25:01 |
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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
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
masuzuki@fmu.ac.jp
Sponsor or person
Institute
Aizu Medical Center, Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056153
