UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention center
Address	Higashikoiwa 2-24-18 Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Email	how_lowlow@yahoo.co.jp

Public contact
Name of contact person	Miku Sato
Organization	Edogawa Hospital
Division name	Orthopedic Surgery
Address	Higashikoiwa 2-24-18 Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Homepage URL
Email	secretary6@edogawa.or.jp

Sponsor
Institute	Edogawa musculoskeletal intervention study group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020008