UMIN-CTR Clinical Trial

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