UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025018 |
|---|---|
| Receipt number | R000028768 |
| Scientific Title | Safety and efficacy of transcatheter arterial micro-embolization for postherpetic neuralgia resistant to conservative treatment |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/11/28 15:25:05 |
* 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 for postherpetic neuralgia resistant to conservative treatment
Acronym
TAME for PHN
Scientific Title
Safety and efficacy of transcatheter arterial micro-embolization for postherpetic neuralgia resistant to conservative treatment
Scientific Title:Acronym
TAME for PHN
Region
| Japan |
Condition
Condition
Postherpetic neuralgia refractory to conservative treatment
Classification by specialty
| Dermatology | Radiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of transcatheter arterial micro-embolization for postherpetic neuralgia refractory to conservative treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of Adverse events
Key secondary outcomes
Change of Brief Pain Inventory score
Change of pain NRS score
Change of pain surface area per total body surface area
Change of QOL score
Change of Pain Catastrophizing scale
Change of frequency and amount of other treatment
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.Patients who were diagnosed as postherpetic neuralgia
2.Patients who maintain major organ (bone marrow, heart, liver, lung, kidney) function.
3.Patients who have been treated by conservative treatment for more than 3 months and persistent moderate to severe pain (NRS>5)
4.Within 3 years from disease onset
5. age>20, age<80
6. Provided written informed consent to undergo the procedure.
Key exclusion criteria
1.Location of disease seems to be not feasible to insert catheter by the results of imaging assessment using contrast enhanced computed tomography
2.patients with more than 4 year history of pain
3.Severe arteriosclerosis
4.mental illness
5.Iodine Allergy
6.Reheumatoid disease
7.Fibromyalgia
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, neoplasm
10,Pregnant female
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
Musculoskeletal Intervention Center
Zip code
Address
Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL
03-3673-1221
okuno@edogawa.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Okuno |
Organization
Edogawa Hospital
Division name
Musculoskeletal Intervention Center
Zip code
Address
Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL
03-3673-1221
Homepage URL
okuno@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Multidisciplinary Pain Center, Aichi Medical University
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | 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
Date of protocol fixation
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 28 | Day |
Last modified on
| 2016 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028768
