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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039381
Receipt No. 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

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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
Email 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
Email umeki@okuno-y-clinic.com

Sponsor
Institute MSK Intervention Center, Edogawa Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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