UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026094
Receipt No. R000029986
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.
Date of disclosure of the study information 2017/04/02
Last modified on 2019/06/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.