Clinical Trial for Efficacy and Safety Evaluation of Neurostimulation using Electroacupuncture in Patients with Anxiety Disorder

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: Others(electroacupuncture) : Participants will be randomly assigned to PC6 electroacupuncture‐median nerve stimulation (EA‐MNS) group or TF4 electroacupuncture‐vagus nerve stimulation (EA‐VNS) group or usual care (UC) group. Participants in EA‐MNS and EA‐VNS groups will receive 16 treatments for 8 weeks and participants in UC group will not receive any intervention and maintain their daily cares for 8 weeks. Stimulation will be delivered with pulse trains at 12Hz for EA‐MNS and 100Hz for EA‐VNS for 20 minutes. Stimulus intensity will be set to 4 5 out of 10 using self‐reported numerical rating score. CONDITION: Mental and behavioural disorders PRIMARY OUTCOME: Hamilton Anxiety Rating Scale SECONDARY OUTCOME: Beck Anxiety Inventory Beck Depression Inventory Liebowitz Social Anxiety Scale (only for Social anxiety disorder) Patient Health Questionnaire‐15 Penn State Worry Questionnaire (only for Generalized anxiety disorder, Other specified anxiety disorders, Anxiety disorder, unspecified) The Panic Disorder Severity Scale (only for Panic disorder and Agoraphobia) WHO QoL assessment instrument abbreviated version INCLUSION CRITERIA: Participants who 1) aged 19‐70 years old 2) diagnosed of anxiety disorder by Structured Clinical Interview for DSM‐5 including social anxiety disorder, agoraphobia, panic disorder, generalized anxiety disorder, other specified anxiety disorders and unspecified anxiety disorder 3) voluntarily decide to participate in this clinical study and signed the written consent form 4) are able to complete electroacupuntrue‐neural stimulation treatments for 8 weeks
Epistemonikos ID: 7329450464a90550df59358273351a7024480b0b
First added on: Feb 20, 2024