UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Age-related changes of scapular muscles. Comparison with patient with rotator cuff tears.
Title of the study (Brief title)	Age-related changes of scapular muscles.
Region	Japan

Condition
Condition	rotator cuff tear
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To research age-related changes of scapular muscles by assessment of quality and quantity. And comparison with patient with rotator cuff tears.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle thickness and muscle activity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	ultrasound
Interventions/Control_2	surface electromyography
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	volunteers with nothing of history of shoulder disorder patients with rotator cuff tear (conservative treatment) consent of patient
Key exclusion criteria	history of over head sports experience low back pain
Target sample size	120

Research contact person
Name of lead principal investigator	Shinichi Izumi
Organization	Tohoku University graduate school of biomedical engineering
Division name	Physical medicine and Rehabilitation
Address	2-1 Seiryo-machi, Aobaku, Sendai
TEL	022-717-7336
Email	xxgfs72106p21@yahoo.co.jp

Public contact
Name of contact person	Shuhei Morise
Organization	Tohoku University graduate school of medicine
Division name	Physical medicine and Rehabilitation
Address	2-1 Seiryo-machi, Aobaku, Sendai
TEL	022-717-7336
Homepage URL
Email	shuhei.morise@gmail.com

Sponsor
Institute	Tohoku University graduate school of medicine
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 03 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 31 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 12 Day
Last modified on	2017 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011968