The Effect of Vagus Nerve Stimulation on Pain and Functional Activities in Individuals With Chronic Widespread Pain
Public ClinicalTrials.gov record NCT07080749. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Effects of Vagus Nerve Stimulation on Pain, Muscle Stiffness, Heart Rate, And Functional Activities in Individuals With Chronic Widespread Pain - A Double Blinded Randomized Control Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to examine the effect of vagus nerve stimulation (VNS) on chronic, widespread pain in adults. The study will also evaluate which method of VNS-electrical ear stimulation or deep exhalation breathing-has a more significant impact on pain intensity, quality of life, and emotional well-being. The main questions it aims to answer are: Does vagus nerve stimulation reduce pain intensity in individuals with chronic, widespread pain? Which intervention-electrical ear stimulation or deep exhalation breathing-provides a greater improvement in autonomic function, emotional status, and quality of life? Researchers will compare two active interventions-electrical ear stimulation and deep exhalation breathing-to a no-treatment control group to determine relative effectiveness on pain and related outcomes. Participants will: Be randomly assigned to one of three groups: * Electrical Ear Stimulation: Apply a small, non-invasive device to the ear for 20 minutes, twice daily for two weeks. * Deep Exhalation Breathing: Perform balloon-blowing exercises (four deep exhalations per set) once every waking hour each day for two weeks. * Control Group: Receive no intervention during the two-week period. These participants will complete baseline testing, return after two weeks for follow-up testing, and then be debriefed. They will have the option to withdraw or receive an active treatment after study data collection concludes. Complete four questionnaires to assess pain, emotional state, and quality of life. Undergo physiological assessments including heart rate variability, neck muscle tissue flexibility (via MyotonPro), and pressure pain sensitivity (via pressure algometer), both before and after the 2-week period. Participation includes two in-person sessions (approximately 1 hour each) and daily home practice (for intervention groups) lasting 40-60 minutes per day for two weeks. The study involves minimal risk, and no compensation is provided. Participation is voluntary, and confidentiality will be strictly maintained.
Study identification
- NCT ID
- NCT07080749
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- Vagal nerve stimulation through deep exhalation exercise Other
- Vagal nerve stimulation through ear electrical stimulation Other
- No intervention (observational study) Other
Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 29, 2025
- Primary completion
- Jun 29, 2026
- Completion
- Aug 29, 2026
- Last update posted
- Jul 22, 2025
2025 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of North Georgia | Dahlonega | Georgia | 30597 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07080749, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07080749 live on ClinicalTrials.gov.