Unique ID issued by UMIN | UMIN000031797 |
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Receipt number | 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 10:07:21 |
Transcatheter arterial micro-embolization (TAME) using imipenem/cilastatin sodium for chronic musculoskeletal pain chronic musculoskeletal pain resistant to conservative treatment
Clinical efficacy of TAME for chronic musculoskeletal pain
Transcatheter arterial micro-embolization (TAME) using imipenem/cilastatin sodium for chronic musculoskeletal pain chronic musculoskeletal pain resistant to conservative treatment
Clinical efficacy of TAME for chronic musculoskeletal pain
Japan |
lateral humeral epicondylitis, medial humeral epicondylitis, shoulder periarthritis,
intractable pain after artificial joint surgery, knee osteoarthritis,
hip osteoarthritis
Orthopedics | Radiology |
Others
NO
To evaluate of efficacy of TAME for chronic musculoskeletal pain resistant to conservative treatment
Efficacy
Clinical efficacy
1) Numerical Rating Scale (NRS) in 6 months after the procedure
2) Quality of life (QOL) in 6 months after the procedure
Incidence of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Transcatheter arterial micro embolization: TAME
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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
50
1st name | |
Middle name | |
Last name | Akira Ikoma |
Wakayama medical university
Department of Radiology
811-1 Kimiidera, Wakayama-shi, Wakayama
073-447-2300
w-akira@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Akira Ikoma |
Wakayama medical university
Department of Radiology
811-1 Kimiidera, Wakayama-shi, Wakayama
073-447-2300
w-akira@wakayama-med.ac.jp
Wakayama medical university
none
Self funding
NO
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 03 | Month | 16 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 04 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 19 | Day |
2019 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036296
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