UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031797
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

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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 or person

Institute

Wakayama medical university

Institute

Department

Personal name



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

Value
https://center6.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