UMIN-CTR Clinical Trial

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
Email	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
Email	okah-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053587