Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia

Conditions: Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy, Chronic Widespread Pain, Autonomic Nervous System Dysfunction, taVNS

Sex: Female

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: NA

Enrollment: 44

Sponsor: Hasan Kalyoncu University

Location: Physiotherapist Taha Emre Baz Private health professional service unit Mersin

Summary

The aim of this study is to investigate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) added to manual therapy on pain, autonomic nervous system function, and illness perception in female patients diagnosed with fibromyalgia, using a randomized sham-controlled design.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria, made by a physician * Female, aged 18-65 years * Symptomatic for at least 3 months * Pain intensity of 4 or higher on the Numeric Rating Scale (NRS ≥ 4; moderate to severe pain) * Able to read and write and understand Turkish * Willing to participate in the study (voluntary informed consent) Exclusion Criteria: * Inflammatory rheumatologic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) * Active cardiac arrhythmia or implanted pacemaker * History of vagus nerve damage or vagotomy * Uncontrolled psychiatric disorder * Pregnancy or breastfeeding * Manual therapy or electrotherapy treatment within the last 3 months

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07894588). StuddyBuddy aggregates publicly available trial information.