UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1/2 trial of TAME(:Transcatheter arterial micro embolization) for chronic musculoskeletal pain refractory to non-surgical management
Title of the study (Brief title)	TAME Phase 1/2 study
Region	Japan

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

Objectives
Narrative objectives1	To investigate the feasibility and effect of transcatheter arterial micro embolization: TAME for musculoskeletal chronic pain refractory to non-surgical management
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Feasibility
Key secondary outcomes	Effectiveness Frequency of adverse events

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	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, musculoskeletal shoulder pain, tendinopathy and enthesopathy, sinovitis and bursitis, mild osteoarthritis (KL<3), infrapatellar fat pad inflammation, and residual or reccurent pain after knee replacement surgery. 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	33

Research contact person
Name of lead principal investigator	Yuji Okuno
Organization	Edogawa Hospital
Division name	Orthopedic Surgery
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	Yuji Okuno
Organization	secretariat of Edogawa Musculoskeletal Intervention Study Group
Division name	Orthopedic Surgery
Address	2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Homepage URL
Email	how_lowlow@yahoo.co.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	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Institute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, Japan
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	江戸川病院

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 20 Day
Last follow-up date	2016 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 18 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=R000016719