UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051995 |
|---|---|
| Receipt number | R000059342 |
| Scientific Title | Investigation of Molecular Basis of Sympathetically Maintained Pain in Chronic Orofacial Pain |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2024/05/13 09:21:32 |
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Basic information
Public title
Study on Molecular Basis of Stellate Ganglion Block for Chronic Pain
Acronym
Study on Molecular Basis of Stellate Ganglion Block for Chronic Pain
Scientific Title
Investigation of Molecular Basis of Sympathetically Maintained Pain in Chronic Orofacial Pain
Scientific Title:Acronym
Investigation of Molecular Basis of Sympathetically Maintained Pain in Chronic Orofacial Pain
Region
| Japan |
Condition
Condition
Chronic primary orofacial pain, Chronic secondary orofacial pain
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many cases of chronic orofacial pain are classified as neuropathic or nociplastic pain disorders. These conditions are often influenced by social and psychological stress and tend to be refractory. Sympathetically maintained pain (SMP), which involves sympathetic nervous system activity, is considered to contribute to these conditions. Stellate ganglion block (SGB) has been employed as an interventional treatment for the SMP in the orofacial region. However, the molecular underpinnings altered by SGBs and the pathophysiology of the SMP in the orofacial region remain largely unknown. This study aims to comprehensively explore changes in factors related to pain and stress pre- and post-SGBs.
Basic objectives2
Others
Basic objectives -Others
Understanding the Pathophysiology of Chronic Orofacial Pain
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain- and stress-related biomarkers on pre- and post-SGB in saliva (i.e. Brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), cortisol, alpha-amylase, chromogranin A).
Key secondary outcomes
Other pain- and stress-related biomarkers in saliva or blood (i.e. serotonin, noradrenaline, interleukin-1beta (IL-1beta), IL-6, IL-8, substance P, endorphin, dehydroepiandrosterone, noradrenaline, tumor necrosis factor (TNF-alpha), prostaglandin, leukotriene, enkephalin, bradykinin, vasopressin).
Blood pressure, pulse rate, SPO2, heart rate variability and pain intensity on pre- and post-SGB.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Unilateral stellate ganglion block with local anesthetic (0.5-1% lidocaine hydrochloride, 4-8mL)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with primary or secondary oral-facial pain lasting more than 3 months
Key exclusion criteria
Contraindications to SGB, failures of SGB, accidents by SGB, patients with diagnosed psychiatric disorder.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-0003
Address
82 Inaoka Yokosuka Kanagawa, Japan
TEL
+81-46-822-8751
kuroda@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University Hospital
Division name
Department of Dental Anesthesiology
Zip code
238-0004
Address
1-23 Ogawa Yokosuka Kanagawa, Japan
TEL
+81-46-822-8896
Homepage URL
kuroda@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Dental College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kanagawa Dental University
Address
82 Inaoka Yokosuka Kanagawa, Japan
Tel
+81-46-822-8751
kenkyo@kdu.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
| 2023 | Year | 08 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059342
