UMIN-CTR Clinical Trial

Basic information
Public title	Transcatheter arterial micro-embolization (TAME) using imipenem/cilastatin sodium for chronic musculoskeletal pain chronic musculoskeletal pain resistant to conservative treatment
Acronym	Clinical efficacy of TAME for chronic musculoskeletal pain
Scientific Title	Transcatheter arterial micro-embolization (TAME) using imipenem/cilastatin sodium for chronic musculoskeletal pain chronic musculoskeletal pain resistant to conservative treatment
Scientific Title:Acronym	Clinical efficacy of TAME for chronic musculoskeletal pain
Region	Japan

Condition
Condition	lateral humeral epicondylitis, medial humeral epicondylitis, shoulder periarthritis, intractable pain after artificial joint surgery, knee osteoarthritis, hip osteoarthritis
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate of efficacy of TAME for chronic musculoskeletal pain resistant to conservative treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical efficacy 1) Numerical Rating Scale (NRS) in 6 months after the procedure 2) Quality of life (QOL) in 6 months after the procedure
Key secondary outcomes	Incidence of adverse events

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 hip pain (NRS>=5). 2) Patients with maintain major organ (bone marrow, heart, liver, lung, kidney) function. Hb: more than 10.0g/dL WBC: more than 3,000/mm3, less than 12,000/mm3 Plt: more than 70,000/mm3 Cr: less than 1.5mg/dL 3) 20 years of age or older and less than 80 years of age, gender is unquestioned 4) Patients with possibility of going to hospital and follow up for 6 months. 5) Provided written informed consent to undergo the procedure.
Key exclusion criteria	1)Surgical candidate 2)Patients with major depression 3)Patients with uncontrollable diabetic mellitus 4)Patients without possibility of going to hospital and follow up for 6 months. 5)Patient who was decided not to be appropriate for this trial by physician 6)Patients with a history of hypersensitivity or shock to antibiotics of imipenem . cilastatin, carbapenem, penicillin or cephem 7)Patients who are receiving sodium valproate 8)Patients with a history of severe thrombotic symptoms such as myocardial infarction and cerebral infarction 9)Patients diagnosed as anti-phospholipid antibody syndrome 10)Patients performing antiplatelet drugs or anticoagulation therapy 11)Patients diagnosed as collagen diseases such as rheumatoid arthritis and polymyalgia rheumatic 12)Pregnant patient
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Akira Ikoma
Organization	Wakayama medical university
Division name	Department of Radiology
Zip code
Address	811-1 Kimiidera, Wakayama-shi, Wakayama
TEL	073-447-2300
Email	w-akira@wakayama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Akira Ikoma
Organization	Wakayama medical university
Division name	Department of Radiology
Zip code
Address	811-1 Kimiidera, Wakayama-shi, Wakayama
TEL	073-447-2300
Homepage URL
Email	w-akira@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical university
Institute
Department

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 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	Completed
Date of protocol fixation	2018 Year 03 Month 16 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 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	2018 Year 03 Month 19 Day
Last modified on	2019 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036296