UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039381 |
|---|---|
| Receipt number | R000044882 |
| Scientific Title | Effects of Transcatheter Arterial Micro embolization for Persistent Trapezius Myalgia Refractory to Conservative Treatment: A Retrospective Study |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2020/02/19 11:33:19 |
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Basic information
Public title
Effects of Transcatheter Arterial Micro embolization for Persistent Trapezius Myalgia Refractory to Conservative Treatment: A Retrospective Study
Acronym
Retrospective study of TAME For TM
Scientific Title
Effects of Transcatheter Arterial Micro embolization for Persistent Trapezius Myalgia Refractory to Conservative Treatment: A Retrospective Study
Scientific Title:Acronym
Retrospective study of TAME For TM
Region
| Japan |
Condition
Condition
Trapezius Myalgia
Classification by specialty
| Orthopedics | Radiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of TAME for patients with refractory TM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Clinical success rate at 3 months after treatment
Key secondary outcomes
Complications
change of Brief Pain Inventory
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
we perform a retrospective study assessing the clinical course of patients who underwent TAME during 2017 to 2019
Key exclusion criteria
none
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Okuno |
Organization
Edogawa Hospital
Division name
MSK Intervention center
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL
+81-3-3673-1221
okuno@okuno-y-clinic.com
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Umeki |
Organization
MSK Intervention Research Center
Division name
Research Department
Zip code
107-0062
Address
3rd-floor, 2-11-11, Minamiaoyama, Minato-ku, Tokyo, Japan
TEL
+81-3-6801-6539
Homepage URL
umeki@okuno-y-clinic.com
Sponsor or person
Institute
MSK Intervention Center, Edogawa Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
Tel
+81-3-3673-1221
secretary@edogawa.or.jp
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
| 2020 | Year | 02 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively evaluated the prospectively collected data of 42 patients with TM who were treated with TAME between Oct 2017 to 2019 January.
Management information
Registered date
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044882
