UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021238 |
|---|---|
| Receipt number | R000024500 |
| Scientific Title | Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain : Multicenter Study |
| Date of disclosure of the study information | 2016/02/28 |
| Last modified on | 2020/02/25 13:25:29 |
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Basic information
Public title
Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain : Multicenter Study
Acronym
shoulde TAME : JMIS-1601 (TAME-II)
Scientific Title
Effectiveness of Transcatheter arterial micro-emblization for nighttime shoulder pain : Multicenter Study
Scientific Title:Acronym
shoulde TAME : JMIS-1601 (TAME-II)
Region
| Japan |
Condition
Condition
nighttime shoulder pain refractory to non-surgical management
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of Transcatheter arterial micro embolization for nighttime shoulder pain refractory to non-surgical management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Numerical Rating Scale (NRS) in 6 months after procedure
range of motion (ROM) in 6 months after procedure
Quality of Life(QOL) in 6 months after procedure
Key secondary outcomes
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 pain (VAS > 50mm).
2.Patients with following diagnosis: adhesive capsulitis, Inoperable rotator cuff injury
3. Patients who maintain major organ (bone marrow, heart, liver, lung, kidney) function.
4. Provided written informed consent to undergo the procedure.
Key exclusion criteria
1.Reheumatoid arthritis
2.Neoplasm
3.Severe arteriosclerosis
4.Pregnant female
5.Dementia
6.Complaining joint instability
7.Iodine Allergy
8.Patients with severe cardiac disease, cerebrovascular disease, neurological disease, uncontrollable diabetic mellitus and hypertension, severe infection, intestinal bleeding, interstitial pneumonia, ascites fluid, pleural effusion.
9, Pain due to cervical or lumbar spine pathology
10,Patients who was decided not to be appropriate for this trial by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Okuno |
Organization
Edogawa Hospital
Division name
Orthopedic Surgery
Zip code
Address
2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan
TEL
03-3673-1221
how_lowlow@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Komemushi |
Organization
Kansai Medical University
Division name
Radiology
Zip code
Address
10-15, Fumizono, Moriguchi, OSAKA, 570-8507, JAPAN
TEL
06-6992-1001
Homepage URL
tame.trial@gmail.com
Sponsor or person
Institute
Edogawa Hospital
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
社会福祉法人仁生社 江戸川病院（東京都）
関西医科大学附属滝井病院 放射線科（大阪府）
都島放射線科クリニック 放射線科（大阪府）
奈良県立医科大学 放射線科（奈良県）
南大阪医療センター 放射線科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2016 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024500
