UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051866 |
|---|---|
| Receipt number | R000059180 |
| Scientific Title | A Randomized Controlled Trial of the Efficacy of Health-Keepers for Reduced Productivity Due to Nonspecific Chronic Musculoskeletal Pain |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2024/02/13 18:09:42 |
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Basic information
Public title
A Randomized Controlled Trial of the Efficacy of Health-Keepers for Reduced Productivity Due to Nonspecific Chronic Musculoskeletal Pain
Acronym
Randomized Controlled Trial of the Efficacy of Health-keepers for Presenteeism
Scientific Title
A Randomized Controlled Trial of the Efficacy of Health-Keepers for Reduced Productivity Due to Nonspecific Chronic Musculoskeletal Pain
Scientific Title:Acronym
Randomized Controlled Trial of the Efficacy of Health-keepers for Presenteeism
Region
| Japan |
Condition
Condition
Nonspecific Chronic Musculoskeletal Pain
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To contribute to the spread and expansion of "Health-Keepers"
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presenteeism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Usual intervention group (receive interventions as desired)
Interventions/Control_2
Active intervention group (receives intervention at least once a week)
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Workers who are aware of decreased productivity (presenteeism) due to nonspecific chronic musculoskeletal pain such as "stiff shoulders" or "back pain" in the past 4 weeks.
Key exclusion criteria
Workers deemed ineligible for this study by the responsible physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
Department of Acupuncture and Moxibustion, Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
TEL
+81-3-5843-3111
s.miyazaki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
TEL
+81-3-5843-3111
Homepage URL
s.miyazaki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
None
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
Teikyo Heisei University Ethical Committee
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo, Japan
Tel
+81-3-5843-3111
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
| 2023 | Year | 08 | Month | 08 | 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
32
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059180
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
