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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031797
Receipt No. R000036296
Scientific Title Transcatheter arterial micro-embolization (TAME) using imipenem/cilastatin sodium for chronic musculoskeletal pain chronic musculoskeletal pain resistant to conservative treatment
Date of disclosure of the study information 2018/04/01
Last modified on 2019/03/19

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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