UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000035543|
|Scientific Title||Effects of a rotator cuff exercise by means of combined electrical stimulation and volitional contrction|
|Date of disclosure of the study information||2019/01/20|
|Last modified on||2019/01/15|
|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|
|Condition||Rotator Cuff Dysfunction|
|Classification by specialty||
|Classification by malignancy||Others|
|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 objectives -Others|
|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|
|Blinding||Open -no one is blinded|
|No. of arms||3|
|Purpose of intervention||Treatment|
|Type of intervention||
|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|
|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||
|Address||1-7-12-902, Akasaka, Chuo-ku, Fukuoka-shi, Fukuoka|
|Name of contact person||
|Address||152-1,TadomiUshimaru , Shime-machi, Kasuya-gun, Fukuoka|
|Category of Funding Organization||Self funding|
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|IND to MHLW|
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|Publication of results||Partially published|
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