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

Conditions

• Widspread Chronic Pain, Fibromyalgia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vagal nerve stimulation through deep exhalation exercise — OTHER
  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.
• Vagal nerve stimulation through ear electrical stimulation — OTHER
  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.
• No intervention (observational study) — OTHER
  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.

Study Details

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.

Key Dates

Start date

Aug 30, 2025

Status verified

Jul 2025

Primary completion

Jun 30, 2026

Completion

Aug 30, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Vagal Nerve Stimulation through deep exhalation.
  Vagal nerve stimulation will be performed through deep exhalation exercise, performed once every hour during the waking hours each day.
• Active Comparator: Vagal Nerve Stimulation through ear electrical stimulation
  Vagal nerve stimulation will be performed through applying low frequency electrical stimulation to the external ear lobe for 20 minutes twice a day.
• Other: No intervention
  Participants in this group will not receive any treatment for vagal nerve stimulation.

Primary Outcome Measure

Pain Intensity [ Time Frame: From enrollment to the end of treatment at 2 weeks ]

Central Contacts

• Mohammad Reza Nourbakhsh, PT, Ph.D.
  706 864 1766
  [email protected]
• Rachael Wlton-Mouw, PT, DPT
  706 867 3086
  [email protected]

Locations (1)

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