UMIN-CTR Clinical Trial

Basic information
Public title	Relationshi pwith Neuropathic pain and immunology
Acronym	Neuropathic pain and immunology
Scientific Title	Involvement of cytokines in patients with peripheral neuropathic pain: Relationship to treatment efficacy
Scientific Title:Acronym	Involvement of cytokines in patients with peripheral neuropathic pain
Region	Japan

Condition
Condition	peripheral neuropathic pain
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the efficacy of treatment and changes in quantitative sensory tests (temperature-cold hyperalgesia) and blood levels of cytokines (IL-27, IL-10, TNFarfa , IL-1beta) and Mincle in patients with a diagnosis of peripheral neuropathic pain.
Basic objectives2	Others
Basic objectives -Others	We investigate that cytokines are involved in the mechanism of peripheral neuropathic pain.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	blood levels of cytokines (IL-27, IL-10, TNFarfa, IL-1beta) and Mincle before and after treatment
Key secondary outcomes	VAS (Visual Analogue Scale) measurement, temperature/cold pain measurement, pain-responsive current, and minimal sensing current using a quantitative sensory/algesic analyzer before and after treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	intravenous regionallidocaineinfusion(3 times)
Interventions/Control_2	intravenous regional lidocain with steroid infusion(3 times)
Interventions/Control_3	itravenous regional lidocaine with dexmedetomijin infusion(3 times)
Interventions/Control_4	oral Mirogabalin(4weeks)/no treatment
Interventions/Control_5	oral amitryptirine(4weeks)/no treatment
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients meeting diagnostic criteria for peripheral neuropathic pain, such as Pain DETECT 2) Patients who have never been treated for neuropathic pain 3)Patients who can communicate well.
Key exclusion criteria	1)Pregnant patients or patients of childbearing potential 2) Patients who declared non-participation in the study 3) Patients with significant psychosocial factors 4) Patients who are unable to communicate 5) Patients with coexisting diseases that may cause neurological disorders such as diabetes mellitus (6) Patients who are in court or in litigation due to accidents
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Naomi Middle name Last name Hirakawa
Organization	Faculty of Medicine, Saga University
Division name	Anesthesiology and Critical Care Medicine
Zip code	849-8501
Address	5-1-1,Nabeshima Saga
TEL	0952-34-2321
Email	hirakan@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Naomi Middle name Last name Hirakakwa
Organization	Faculty of Medicine, Saga Uniiversity
Division name	Anesthesiology and Critical Care Medicine
Zip code	849-8501
Address	5-1-1 Nabeshima Saga
TEL	0952-34-2321
Homepage URL
Email	hirakan@cc.saga-u.ac.jp

Sponsor
Institute	Department of Anesthesiology & Critical Care Medicine Faculty of Medicine, Saga University
Institute
Department

Funding Source
Organization	japan Society for the Promotion of Science Grants-in Aid Scientific Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Center Saga University Hospital
Address	5-1-1 Nabeshima Saga
Tel	0952-34-3400
Email	sh1274@cc.saga-u.ac.jp

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	2022 Year 11 Month 07 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	Preinitiation
Date of protocol fixation	2022 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date	2022 Year 11 Month 07 Day
Last follow-up date	2023 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	2022 Year 09 Month 21 Day
Last modified on	2022 Year 09 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055697