UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048989 |
|---|---|
| Receipt number | R000055697 |
| Scientific Title | Involvement of cytokines in patients with peripheral neuropathic pain: Relationship to treatment efficacy |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2022/09/21 16:41:46 |
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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
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
hirakan@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology & Critical Care Medicine
Faculty of Medicine, Saga University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055697
