UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of transcatheter arterial micro embolization (TAME) using Imipenem / Cilastatin (IPM/CS) for chronic musculoskeletal pain refractory to non-surgical management.
Acronym	Safety and efficacy of TAME for chronic musculoskeletal pain refractory to non-surgical management.
Scientific Title	Safety and efficacy of transcatheter arterial micro embolization (TAME) using Imipenem / Cilastatin (IPM/CS) for chronic musculoskeletal pain refractory to non-surgical management.
Scientific Title:Acronym	Safety and efficacy of TAME for chronic musculoskeletal pain refractory to non-surgical management.
Region	Japan

Condition
Condition	Musculoskeletal chronic pain refractory to non-surgical management(Glenohumeral joint, elbow joint, hip joint and knee joint)
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety and efficacy of TAME using Imipenem / Cilastatin for chronic musculoskeletal pain refractory to non-surgical management.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Numerical Rating Scale(NRS)of pain.
Key secondary outcomes	Feasibility of TAME. Region of joint. QOL using EQ5D. Imaging of MRI.

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 using IPM/CS
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	Previous conservative therapies applied for at least 3 months and persistent moderate-to-severe pain(NRS > 50mm). 2) Elbow, shoulder, hip, knee joint pain. For example, 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) Below 80 years old in age at the time of the agreement acquisition 20 years old or older. 5) Patients who going to hospital follow-up after this treatment enforcement is possible. 6) Provided written informed consent to undergo the procedure. 7) Patients who abnormal vessels are recognized in an angiography.
Key exclusion criteria	1)Adaptation of treating surgically. 2)Neoplasm 3)Severe arteriosclerosis 4)Pregnant female, female with the possibility of the pregnancy or nursing female 5)6)Iodine Allergy 7)IPM/CS Allergy 8)Using sodium valproate 9)Patients with the past of hypersensitivity for carbapenem system, penicillin system or cephem antibiotics. 10)Severe depression 11)Uncontrollable severe diabetes mellitus 12)Patients who have difficulty in going to hospital follow-up after this treatment enforcement. 13)Patients who abnormal vessels are not recognized in an angiography.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasufumi Ohuchi
Organization	Tottori university, Faculty of medicine
Division name	Department of radiology
Zip code
Address	Nishicho36-1, Yonago, Tottori, Japan
TEL	0859-38-6637
Email	yasutori0513@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yasufumi Ohuchi
Organization	Tottori university, Faculty of medicine
Division name	Department of radiology
Zip code
Address	Nishicho36-1, Yonago, Tottori, Japan
TEL	0859-38-6637
Homepage URL
Email	yasutori0513@yahoo.co.jp

Sponsor
Institute	Tottori university, Faculty of medicine
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	鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 02 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	Terminated
Date of protocol fixation	2017 Year 03 Month 08 Day
Date of IRB	2017 Year 03 Month 30 Day
Anticipated trial start date	2017 Year 04 Month 02 Day
Last follow-up date	2020 Year 03 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	2017 Year 02 Month 11 Day
Last modified on	2019 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029986