UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain : Multicenter Study
Acronym	shoulde TAME : JMIS-1601 (TAME-II)
Scientific Title	Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain : Multicenter Study
Scientific Title:Acronym	shoulde TAME : JMIS-1601 (TAME-II)
Region	Japan

Condition
Condition	nighttime shoulder pain refractory to non-surgical management
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of Transcatheter arterial micro embolization for nighttime shoulder pain refractory to non-surgical management
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Numerical Rating Scale (NRS) in 6 months after procedure range of motion (ROM) in 6 months after procedure Quality of Life(QOL) in 6 months after procedure
Key secondary outcomes

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: TAME
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	1. Previous conservative therapies applied for at least 3 months and persistent moderate-to-severe pain (VAS > 50mm). 2.Patients with following diagnosis: adhesive capsulitis, Inoperable rotator cuff injury 3. Patients who maintain major organ (bone marrow, heart, liver, lung, kidney) function. 4. Provided written informed consent to undergo the procedure.
Key exclusion criteria	1.Reheumatoid arthritis 2.Neoplasm 3.Severe arteriosclerosis 4.Pregnant female 5.Dementia 6.Complaining joint instability 7.Iodine Allergy 8.Patients with severe cardiac disease, cerebrovascular disease, neurological disease, uncontrollable diabetic mellitus and hypertension, severe infection, intestinal bleeding, interstitial pneumonia, ascites fluid, pleural effusion. 9, Pain due to cervical or lumbar spine pathology 10,Patients who was decided not to be appropriate for this trial by physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuji Okuno
Organization	Edogawa Hospital
Division name	Orthopedic Surgery
Zip code
Address	2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Email	how_lowlow@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Komemushi
Organization	Kansai Medical University
Division name	Radiology
Zip code
Address	10-15, Fumizono, Moriguchi, OSAKA, 570-8507, JAPAN
TEL	06-6992-1001
Homepage URL
Email	tame.trial@gmail.com

Sponsor
Institute	Edogawa Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	社会福祉法人仁生社　江戸川病院（東京都） 関西医科大学附属滝井病院　放射線科（大阪府） 都島放射線科クリニック　放射線科（大阪府） 奈良県立医科大学　放射線科（奈良県）　 南大阪医療センター　放射線科（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 28 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	2016 Year 02 Month 28 Day
Date of IRB	2016 Year 02 Month 15 Day
Anticipated trial start date	2016 Year 02 Month 28 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 28 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024500