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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041398
Receipt No. R000047261
Scientific Title Acupuncture for chronic musculoskeletal pain in elderly patients.
Date of disclosure of the study information 2020/08/14
Last modified on 2021/08/13

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Basic information
Public title Acupuncture for chronic musculoskeletal pain in elderly patients.
Acronym ACMPE
Scientific Title Acupuncture for chronic musculoskeletal pain in elderly patients.
Scientific Title:Acronym ACMPE
Region
Japan

Condition
Condition chronic musculoskeletal pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate whether adding acupuncture to an exercise instruction is a useful countermeasure for the treatment of chronic musculoskeletal pain in the elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numerical Rating Scale
Key secondary outcomes

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
Behavior,custom Maneuver
Interventions/Control_1 exercise instruction
Interventions/Control_2 exercise instruction and acupuncture therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Person ages 65 years or over.
2.Those who have chronic musculoskeletal pain for more than 3 months.
(NRS4-10,Excludes trauma such as fractures and treatments requiring surgery.)
3.Those who can go to the research facility.
4.No problem with cognitive function.
5.Those who is not pauper.
6.Person who can agree even if assigned to control group.
7.Those who do not allow drug changes during this 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 16

Research contact person
Name of lead principal investigator
1st name Yoichi
Middle name
Last name Minakawa
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 y.minakawa@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 Teikyo Heisei University
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 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
2020 Year 08 Month 14 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 15
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
2020 Year 08 Month 01 Day
Date of IRB
2020 Year 07 Month 13 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 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
2020 Year 08 Month 12 Day
Last modified on
2021 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047261

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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