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

Launched by UNIVERSITY OF NORTH GEORGIA · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called vagus nerve stimulation (VNS) can help reduce long-lasting, widespread pain, such as fibromyalgia, in adults. The study compares two ways of doing VNS: one uses a small device placed on the ear that sends gentle electrical signals, and the other involves a breathing exercise where participants blow up balloons several times an hour. Researchers want to see which method works better to lower pain, improve mood, and enhance quality of life. There is also a group that will not receive any treatment during the study, to help compare the results.

Adults aged 18 and older who have been diagnosed with chronic widespread pain or fibromyalgia may be eligible, as long as they do not have certain health problems like heart, lung, neurological, or ear conditions, or sensitivities to electrical stimulation. Participants will be randomly assigned to one of the three groups and will take part in two in-person visits, with daily practice at home for two weeks. Those in the ear stimulation group will use the device twice a day, while those in the breathing group will do balloon-blowing exercises every hour during the day. Everyone will complete questionnaires about their pain and well-being and have simple physical tests before and after the two weeks. The study involves minimal risk, no payment, and all information will be kept private. Participation is voluntary, and those in the no-treatment group can choose to try an active treatment after the study ends.

Gender

ALL

Eligibility criteria

• 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