UMIN-CTR Clinical Trial

Basic information
Public title	Association between stiff shoulder and physical characteristics
Acronym	Association between stiff shoulder and physical characteristics
Scientific Title	Association between stiff shoulder and physical characteristics
Scientific Title:Acronym	Association between stiff shoulder and physical characteristics
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify physical characteristics and muscle activities during desk work causing stiff sholder
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cubic volume of head and neck, eyesight, chest circumstance, muscle stiffness, muscle activity and aligment during desk work
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Writing and recording of muscle activity arround neck and scapula in participants with stiff shoulder
Interventions/Control_2	Writing and recording of muscle activity arround neck and scapula in participants without stiff shoulder
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Individuals have stiff shoulder or no stiff shoulder
Key exclusion criteria	Individuals suffer from neurological symptoms
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoichiro Middle name Last name Sato
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy
Zip code	0068585
Address	7-15-4-1 Maeda, Teine, Sapporo
TEL	011-688-7192
Email	sato-y@hus.ac.jp

Public contact
Name of contact person	1st name Yoichiro Middle name Last name Sato
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy
Zip code	0068585
Address	7-15-4-1 Maeda, Teine, Sapporo
TEL	011-688-7192
Homepage URL
Email	sato-y@hus.ac.jp

Sponsor
Institute	Hokkaido University of Science
Institute
Department

Funding Source
Organization	Hokkaido University of Science
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	Hokkaido University of Science
Address	15-4-1, Maeda 7-jo, Teine
Tel	0116887192
Email	kenkyu@hus.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	2018 Year 03 Month 15 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	20
Results	Individuals with shoulder stiffness indicate high activity of the upper trapezius muscles in rest rather than in working.
Results date posted	2020 Year 03 Month 25 Day
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	2018 Year 01 Month 30 Day
Date of IRB	2018 Year 03 Month 20 Day
Anticipated trial start date	2018 Year 04 Month 02 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 14 Day
Last modified on	2021 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036205