UMIN-ICDS Clinical Trial

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

Rotator Cuff Dysfunction

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

HISATSUNE HOSPITAL

Institute

Department

Personal name

Organization

HISATSUNE HOSPITAL

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2019

Year

01

Month

15

Day

Last modified on

2020

Year

01

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040457