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
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
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
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
