UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of transcatheter arterial micro-embolization for postherpetic neuralgia resistant to conservative treatment
Title of the study (Brief title)	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	Yuji Okuno
Organization	Edogawa hospital
Division name	Musculoskeletal Intervention Center
Address	Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Email	okuno@edogawa.or.jp

Public contact
Name of contact person	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention Center
Address	Higashikoiwa 2-24-18, Edogawa-ku, Tokyo, Japan
TEL	03-3673-1221
Homepage URL
Email	okuno@edogawa.or.jp

Sponsor
Institute	Edogawa Hospital
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028768