The Effect of Vagus Nerve Stimulation on Pain and Functional Activities in Individuals With Chronic Widespread Pain
Not yet recruitingNot applicableNCT07080749
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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. Participa…
Study details
- 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
- Conditions
- Widspread Chronic Pain, Fibromyalgia
- Interventions
- Other: Vagal nerve stimulation through deep exhalation exercise
- Other: Vagal nerve stimulation through ear electrical stimulation
- Other: No intervention (observational study)
- Sponsor
- University of North Georgia
- Start date
- 2025-08-30
- Primary completion
- 2026-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Adults 18 years of age or older Diagnosed by a healthcare provider with chronic widespread pain or fibromyalgia Exclusion Criteria: Cardiovascular disorders: Such as arrhythmia (irregular heartbeat), heart failure, coronary artery disease, or history of heart surgery Neurological disorders: Including epilepsy, Parkinson's disease, multiple sclerosis, neuropathy, or seizures Endocrine disorders: Such as uncontrolled diabetes, thyroid disease (hypothyroidism or hyperthyroidism), or adrenal disorders Gastrointestinal disorders: Including inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel syndrome, or chronic acid reflux (GERD) Respiratory disorders: Such as asthma, chronic bronchitis, emphysema, or sleep apnea Vestibular disorders: Including Meniere's disease, benign paroxysmal positional vertigo (BPPV), or any condition causing balance problems History of concussion or traumatic brain injury Frequent dizziness or vertigo: History of unexplained or recurring episodes Chronic or recurrent headaches: Including migraines, tension-type headaches, or cluster headaches Ear problems: History of ear infections, hearing loss, tinnitus (ringing in the ears), or ear surgeries Throat problems: History of chronic sore throat, difficulty swallowing (dysphagia), or throat surgery Herniation: History of any type of herniation such as spinal disc herniation, inguinal (groin) hernia, or abdominal hernia Skin sensitivity to electrical stimulation: Known allergic reaction, rash, or irritation from electrode pads or electrical devices applied to the skin
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07080749