UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a rotator cuff exercise by means of combined electrical stimulation and volitional contrction
Acronym	Effects of a rotator cuff exercise by means of combined electrical stimulation and volitional contrction
Scientific Title	Effects of a rotator cuff exercise by means of combined electrical stimulation and volitional contrction
Scientific Title:Acronym	Effects of a rotator cuff exercise by means of combined electrical stimulation and volitional contrction
Region	Japan

Condition
Condition	Rotator Cuff Dysfunction
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The muscular strength reinforcement training is indispensable for many people regardless of any people regardless of age or sex as well as the training of the contestant. Various studies have been accomplished about the method of the muscular strength reinforcement training so far. Above all nerve line electrical stimulation (neuromuscular electrical stimulation:) NMES) causes muscular contraction by adding electrical stimulation to a skeletal muscle, and the muscular strength reinforcement, a nerve line are physical therapy maneuvers for the purpose of facilitating it. We gave NMES to an antagonist and devised a method to have a characteristic to manufacture exercise of main movement muscle resistance for the muscular contraction in the body. I perform 40 studies in total for the people more than 400 using antagonist electrical stimulation, and we demonstrated that a reinforcement effect of the muscular strength of upper lower limbs is provided safely, but there is not the study using the antagonist electrical stimulation to glenohumeral joint until now. Because it is necessary to control the shrinkage of the outer muscle so that shearing force does not work between head of humerus and shoulder blade glenoid fossae when I perform the training of the rotator cuff line that is the inner muscle of the glenohumeral joint, and outer muscle is active when training load quantity increases, it is said that the relative reinforcement effect of the inner muscle decreases adversely. Therefore it is recommended that I perform the rotator cuff line training with low load. The training in the tube is recommended, but the documents which evaluated degree of the muscular strength reinforcement by the training usually appear. We are intended to inspect the muscular strength reinforcement effect of the glenohumeral joint rotator cuff by comparing the training using the antagonist electrical stimulation with the conventional training this time.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Age,sex,height,the weight Science views: Glenohumeral joint evaluation 11 items MRI: Infraspinatus muscle line cross section (sagittal section) at rest An echo: Resting period, infraspinatus muscle line thickness at the time of the shrinkage, degree CYBEX: of the muscle fatigue after the training Internal rotation, external rotation muscular strength (angular velocity 60 degrees /sec, 180 degrees /sec ,) EMG: in the glenohumeral joint descent rank MVC at the time of the external rotation, 50%MVC, 10%MVC I perform the three times measurement(when possible four times of plans of eight weeks)at the time of the end in total before the enforcement of the electrical stimulation for six weeks for three weeks.I grind a measurement place about MRI, an echo, the EMG three times if the same.
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	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The group which performs antagonist electrical stimulation By 2 pole affixes a surface electrode to pectoralis major muscle, infraspinatus muscle as a stimulation part. Electricity stimulates an antagonist in glenohumeral joint 1st position and performs an internal rotation, external rotation campaign of the glenohumeral joint (internal rotation 60 degrees - external rotation 30 degrees) against the stimulation. I do the stimulation with 80% of maximum durability voltage not to feel unpleasantness at the time of an internal rotation, external rotation campaign of the glenohumeral joint. The stimulation time 1 movement two seconds (internal rotation:) For one second, I externally rotate: I assume ten times one set in) for one second. I do the break between the set with one minute and perform eight sets in total three times a week (every other day) six weeks.
Interventions/Control_2	The group which holds a training law with the conventional tube I perform internal rotation, external rotation of 30 times with one set together using Elastic band(yellow). I do the break between the set with one minute and perform three sets in total three times a week (every other day) six weeks.
Interventions/Control_3	The control group that I do not train at all
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	The physically unimpaired person whom there is not who is abnormal to glenohumeral joint
Key exclusion criteria	Person with abnormality some kind of to glenohumeral joint
Target sample size	100

Research contact person
Name of lead principal investigator	1st name KOJI Middle name Last name HARA
Organization	HISATSUNE HOSPITAL
Division name	orthopedics
Zip code	810-0042
Address	1-7-12-902, Akasaka, Chuo-ku, Fukuoka-shi, Fukuoka
TEL	090-5727-1546
Email	hara_kouji@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name KOJI Middle name Last name HARA
Organization	HISATSUNE HOSPITAL
Division name	orthopedics
Zip code	811-2204
Address	152-1,TadomiUshimaru , Shime-machi, Kasuya-gun, Fukuoka
TEL	092-932-0133
Homepage URL
Email	hara_kouji@med.kurume-u.ac.jp

Sponsor
Institute	HISATSUNE HOSPITAL
Institute
Department

Funding Source
Organization	HISATSUNE HOSPITAL
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	HISATSUNE HOSPITAL
Address	152-1,TadomiUshimaru , Shime-machi, Kasuya-gun, Fukuoka
Tel	092-932-0133
Email	hara_kouji@med.kurume-u.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	2019 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2019 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date	2019 Year 01 Month 21 Day
Last follow-up date	2023 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 15 Day
Last modified on	2020 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040457