UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057706 |
|---|---|
| Receipt number | R000065399 |
| Scientific Title | Single-blind, randomized parallel-group trial on the augmentative effect and safety of taVNS on cognitive behavioral therapy for chronic pain |
| Date of disclosure of the study information | 2025/04/26 |
| Last modified on | 2025/04/25 13:46:36 |
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Basic information
Public title
Single-blind, randomized parallel-group trial on the augmentative effect and safety of taVNS on cognitive behavioral therapy for chronic pain
Acronym
Randomized controlled trial on the augmentative effect of taVNS on cognitive behavioral therapy
Scientific Title
Single-blind, randomized parallel-group trial on the augmentative effect and safety of taVNS on cognitive behavioral therapy for chronic pain
Scientific Title:Acronym
Randomized controlled trial on the augmentative effect of taVNS on cognitive behavioral therapy
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Medicine in general | Surgery in general | Psychiatry |
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether the effects of Cognitive Behavioral Therapy (CBT) for chronic pain can be enhanced by transcutaneous auricular Vagus Nerve Stimulation (taVNS). To this end, we will recruit patients with chronic pain and assign them to either an active taVNS group or a sham stimulation group, and compare the degree of pain improvement following CBT between the two groups. Additionally, to explore the underlying mechanisms, we will employ the cold and pain tasks previously used in our studies to investigate differences in generalization between the groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Numeric Rating Scale (NRS) scores before and after CBT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
active taVNS
Interventions/Control_2
sham stimulation
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Outpatients at Hiroshima University Hospital
2 Aged 18 years or older
3 Experiencing significant interference with daily life due to pain within the past 6 months
4 Meeting the diagnostic criteria for chronic pain (experiencing pain on more than 90 days over the past 6 months)
5 Reporting pain intensity of 30 or higher on a Numerical Rating Scale (NRS 0_100) on more than 45 days during the past 3 months
6 Providing written informed consent
Key exclusion criteria
(1) Individuals aged 70 years or older
(2) Individuals with mental conditions that make it difficult to understand the purpose of the study (e.g., those with active symptoms of dementia, delirium, hallucinations, delusions, manic episodes, or suicidal ideation; other psychiatric disorders with less severe symptoms are not necessarily excluded)
(3) Individuals with severe physical illnesses that prevent participation in the study
(4) Individuals with organic brain disorders (e.g., cerebral hemorrhage or cerebral infarction)
(5) Individuals with alcohol use disorder or substance use disorder
(6) Individuals deemed inappropriate for participation in the study by the principal investigator or co-investigators
(7) Individuals who have previously received Cognitive Behavioral Therapy (CBT)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Atsuo |
| Middle name | |
| Last name | Yoshino |
Organization
Hiroshima University
Division name
Health Service Center/ Center for Brain Mind and Kansei Science Research
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
08225752096
yoshino@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuo |
| Middle name | |
| Last name | Yoshino |
Organization
Hiroshima University
Division name
Health Service Center/ Center for Brain Mind and Kansei Science Research
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
0822575096
Homepage URL
yoshino@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Atsuo Yoshino
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
| 2025 | Year | 04 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2032 | Year | 12 | 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
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065399
