UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017524 |
|---|---|
| Receipt number | R000020008 |
| Scientific Title | Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain |
| Date of disclosure of the study information | 2015/05/13 |
| Last modified on | 2016/05/06 15:00:03 |
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Basic information
Public title
Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain
Acronym
TAME for nighttime shoulder pain
Scientific Title
Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain
Scientific Title:Acronym
TAME for nighttime shoulder pain
Region
| Japan |
Condition
Condition
nighttime shoulder pain refractory to traditional managements
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility and effectiveness of transcatheter arterial micro-embolization for nighttime shoulder pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
VAS
Pittsburgh Sleep Quality Index
Key secondary outcomes
Pain Catastolophsing Scale
Serum CRP
shoulder functional score (ASES)
Ultrasonographic findings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transcatheter arterial micro-embolization
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Musculoskeletal shoulder pain
Nighttime shoulder pain VAS >49mm
Pitsuberg sleep score > 5
Receive conservative treatments for more than 3 motnhs
Key exclusion criteria
previous shouder surgery
advansed arteriosclerosis
pregnancy
reumatoid arthritis
major depression
malignant tumor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Okuno |
Organization
Edogawa Hospital
Division name
Musculoskeletal Intervention center
Zip code
Address
Higashikoiwa 2-24-18 Edogawa-ku, Tokyo, Japan
TEL
03-3673-1221
how_lowlow@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miku Sato |
Organization
Edogawa Hospital
Division name
Orthopedic Surgery
Zip code
Address
Higashikoiwa 2-24-18 Edogawa-ku, Tokyo, Japan
TEL
03-3673-1221
Homepage URL
secretary6@edogawa.or.jp
Sponsor or person
Institute
Edogawa musculoskeletal intervention study group
Institute
Department
Personal name
Funding Source
Organization
Edogawa orthopedic surgery research funding
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
| 2015 | Year | 05 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020008
