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Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Sponsor: Hasan Kalyoncu University
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.
Official title: Effect of Vagal Neuromodulation Added to Manual Therapy on Pain, Autonomic Nervous System, and Illness Perception in Women With Fibromyalgia
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-11-02
Completion Date
2027-03-09
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Non-invasive stimulation delivered through an electrode placed on the left cymba concha, at 25 Hz frequency and 250-500 μs pulse width, with current intensity titrated to the individual sensory threshold below the pain threshold (approximately 0.1-10 mA, in 0.1 mA increments). Applied simultaneously with myofascial release (approximately 25 minutes per session), 3 days per week for 8 weeks.
Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)
An electrode identical in appearance to that of the active group is placed on the left cymba concha, but no electrical current is delivered. Applied during myofascial release (approximately 25 minutes per session), 3 days per week for 8 weeks.
Manual Therapy Program
Myofascial release applied to the upper trapezius, levator scapulae, rhomboids, cervical-lumbar paraspinal regions, and gluteal region, including the tender point areas defined in the ACR fibromyalgia criteria (static, low-intensity pressure held approximately 60-90 seconds per region), and Maitland postero-anterior mobilization of painful cervical, thoracic, and lumbar segments (3 sets of 2 minutes with 1-minute rests). Sessions last 45 minutes, 3 days per week for 8 weeks.
Diaphragmatic Breathing and Stretching Exercises
Elastic band-assisted diaphragmatic breathing training (10-15 minutes per session, sets of 8-10 repetitions) and static stretching of the upper trapezius, pectoral muscles, hamstrings, quadriceps, and gastrocnemius (held 20-30 seconds, 2-3 repetitions), delivered in the same sessions as the manual therapy program, 3 days per week for 8 weeks.
Locations (1)
Physiotherapist Taha Emre Baz Private health professional service unit
Mersin, Turkey (Türkiye)