The Effect of Vagus Nerve Stimulation on Pain and Functional Activities in Individuals With Chronic Widespread Pain

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

August 30, 2026

Conditions
Widspread Chronic Pain, Fibromyalgia
Interventions
OTHER

Vagal nerve stimulation through deep exhalation exercise

Deep Exhalation Treatment: Participants will receive a set of standard balloons to use for deep exhalation. They will sit in a comfortable position, take a deep breath in and blow their breath continuously out into the balloon. They repeat the deep exhalation process for a total of 4 consecutive breaths. They perform this breathing exercise once every hour during waking hours each day.

OTHER

Vagal nerve stimulation through ear electrical stimulation

Ear Electrical Stimulation Treatment: Participants will receive a small electrical stimulator and electrode set to be applied to their left ear. The investigators will train the participants to use the device safely and effectively. Once they are comfortable with the procedure, they will perform the procedure at home for 20 minutes twice daily.

OTHER

No intervention (observational study)

The no intervention group will not receive treatment immediately after their baseline assessments, they will be scheduled for another visit after two weeks, then a new set of baseline measurements will be recorded as the post intervention data.

Trial Locations (1)

30597

University of North Georgia, Dahlonega

All Listed Sponsors
lead

University of North Georgia

OTHER