UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026094 |
|---|---|
| Receipt number | 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 14:09:09 |
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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
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
yasutori0513@yahoo.co.jp
Sponsor or person
Institute
Tottori university, Faculty of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029986
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