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Single-blind, randomized parallel-group trial on the augmentative effect and safety of taVNS on cognitive behavioral therapy for chronic pain

Single-blind, randomized parallel-group trial on the augmentative effect and safety of taVNS on cognitive behavioral therapy for chronic pain - Randomized controlled trial on the augmentative effect of taVNS on cognitive behavioral therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057706
Enrollment
70
Registered
2025-04-26
Start date
2025-04-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain

Interventions

active taVNS sham stimulation

Sponsors

Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Change in Numeric Rating Scale (NRS) scores before and after CBT

Countries

Japan

Contacts

Public ContactAtsuo Yoshino

Hiroshima University Health Service Center/ Center for Brain Mind and Kansei Science Research

yoshino@hiroshima-u.ac.jp0822575096

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026