UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041398 |
|---|---|
| Receipt number | 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 10:03:27 |
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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
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
s.miyazaki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
