UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047613 |
|---|---|
| Receipt number | R000053587 |
| Scientific Title | The study which examines the association between the data from sensors reflecting the shoulder movement and the subjective symptoms of neck and shoulder discomfort and the influence of the guidance for the exercise on these data |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2022/10/31 11:36:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study of the association between the data on the shoulder movement and the subjective symptoms of neck and shoulder discomfort and the influence of the guidance for the exercise on these data
Acronym
Development of a device to monitor neck and shoulder discomfort
Scientific Title
The study which examines the association between the data from sensors reflecting the shoulder movement and the subjective symptoms of neck and shoulder discomfort and the influence of the guidance for the exercise on these data
Scientific Title:Acronym
Development of a device to monitor the movement of the shoulder girdle
Region
| Japan |
Condition
Condition
Neck and shoulder discomfort
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the subjective symptoms of neck and shoulder discomfort and motion of shoulder girdle in workers would change after receiving the guidance for the exercises of shoulder girdle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The wave pattern from the motion senser which would represent the motion of shoulder girdle during desk work
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants will receive the guidance from the orthopedic surgeon regarding the tips for managing the neck and shoulder discomfort and the stretching exercises targeting for neck and shoulder discomfort during the 40-mininute web seminar.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Workers who are 20 years old or older, consent for the participation, and are able to wear the motion senser during desk work
Key exclusion criteria
Individuals who are younger than 20 years old, those with disorders of neck or shoulder, and those with history of surgery in neck or shoulder
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Oka |
| Middle name | |
| Last name | Hiroyuki |
Organization
22nd Century Medical and Research Center, The University of Tokyo Hospital
Division name
Department of Medical Research and Management for Musculoskeletal Pain
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3845-5411
okah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Oka |
| Middle name | |
| Last name | Hiroyuki |
Organization
22nd Century Medical and Research Center, The University of Tokyo Hospital
Division name
Department of Medical Research and Management for Musculoskeletal Pain
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3845-5411
Homepage URL
okah-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
TEIJIN FRONTIER CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Faculty of Medicine, Graduate School of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2022 | Year | 04 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053587
