UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014591 |
|---|---|
| Receipt number | R000016719 |
| Scientific Title | Phase 1/2 trial of TAME(:Transcatheter arterial micro embolization) for chronic musculoskeletal pain refractory to non-surgical management |
| Date of disclosure of the study information | 2014/07/20 |
| Last modified on | 2016/05/06 14:59:11 |
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Basic information
Public title
Phase 1/2 trial of TAME(:Transcatheter arterial micro embolization) for chronic musculoskeletal pain refractory to non-surgical management
Acronym
TAME Phase 1/2 study
Scientific Title
Phase 1/2 trial of TAME(:Transcatheter arterial micro embolization) for chronic musculoskeletal pain refractory to non-surgical management
Scientific Title:Acronym
TAME Phase 1/2 study
Region
| Japan |
Condition
Condition
Musculoskeletal chronic pain refractory to non-surgical management
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility and effect of transcatheter arterial micro embolization: TAME for musculoskeletal chronic pain refractory to non-surgical management
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Effectiveness
Frequency 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
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, 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. 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
33
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 | Yuji Okuno |
Organization
secretariat of Edogawa Musculoskeletal Intervention Study Group
Division name
Orthopedic Surgery
Zip code
Address
2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan
TEL
03-3673-1221
Homepage URL
how_lowlow@yahoo.co.jp
Sponsor or person
Institute
Edogawa Musculoskeletal Intervention Study Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, Japan
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
江戸川病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 20 | 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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 18 | Day |
Last modified on
| 2016 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016719
