UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003729
Receipt number R000004515
Scientific Title Function of the shoulder muscles during shoulder external rotaion:an assessment using positron emission tomography
Date of disclosure of the study information 2010/07/01
Last modified on 2010/06/09 14:06:54

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Basic information

Public title

Function of the shoulder muscles during shoulder external rotaion:an assessment using positron emission tomography

Acronym

Function of the shoulder muscles during shoulder ER:an assessment using PET

Scientific Title

Function of the shoulder muscles during shoulder external rotaion:an assessment using positron emission tomography

Scientific Title:Acronym

Function of the shoulder muscles during shoulder ER:an assessment using PET

Region

Japan


Condition

Condition

Normal

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to investigate the activities of the shoulder muscles during shoulder external rotation using PET.

Basic objectives2

Others

Basic objectives -Others

investigation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The standardized uptake value (SUV) was calculated to quantify their activities. SUV was calculated with the following equation;SUV = (mean VOI count (cps/g)x body weight(g))/(injected dose(MBq) x calibration factor(cps/MBq))

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

50 years-old >=

Gender

Male and Female

Key inclusion criteria

there were no pathologic conditions around the shoulder, including rotator cuff tears

Key exclusion criteria

there were pathologic conditions around the shoulder, including rotator cuff tears
DM

Target sample size

13


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotaka Sano

Organization

Tohoku university

Division name

Orthopaedic sugery

Zip code


Address

Seiryo1-1, Aoba-ku,Sendai, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tohoku university

Division name

Orthopaedic sugery

Zip code


Address


TEL

0227177245

Homepage URL


Email



Sponsor or person

Institute

Tohoku university,School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of
Orthopaedic Surgery
Tohoku University
School of Medicine

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


Address


Tel


Email



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

2010 Year 07 Month 01 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


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

2010 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The FDG, radioactive glucose analog, was injected intravenously via the cubital vein after ER exercise of bilateral arms
(200 repetitions in 10 min) with elastic band in the abduction position or neutral position . The mean dose and standard deviation (SD) of injected FDG was 86.0MBq for the exercise condition. After FDG injection, the subjects were asked to repeat the same exercise of 200 repetitions. Each subject took a 20-s rest after every 40-s exercise (20 repetitions of shoulder ER exercise) to avoid excessive muscle fatigue.


Management information

Registered date

2010 Year 06 Month 09 Day

Last modified on

2010 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004515


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name