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Effects of the Timing of Vagus Nerve Stimulation Combined With Exercise in Chronic Neck Pain
Sponsor: Kutahya Health Sciences University
Summary
This randomized, sham-controlled, parallel-group clinical trial aims to investigate whether the timing of transcutaneous auricular vagus nerve stimulation (taVNS) relative to therapeutic exercise influences pain intensity, disability, autonomic function, and motor performance in individuals with chronic neck pain. A total of 81 participants will be randomly assigned to one of three groups: active taVNS before exercise and sound-sham stimulation after exercise (PRE), sound-sham stimulation before exercise and active taVNS after exercise (POST), or sound-sham stimulation both before and after exercise (CONTROL). All participants will complete a standardized supervised exercise program three times per week for six weeks. The study will use a double-dummy approach to standardize intervention procedures across groups and support blinding. The primary outcome will be neck pain intensity assessed using the Numeric Pain Rating Scale (NPRS). Secondary outcomes will include neck-related disability, heart rate variability, pressure pain threshold, exercise-induced hypoalgesia, and deep cervical flexor motor performance assessed using the craniocervical flexion test.
Official title: Does Timing Matter? Effects of Transcutaneous Auricular Vagus Nerve Stimulation Before and After Exercise in Chronic Neck Pain: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
81
Start Date
2026-11-15
Completion Date
2027-09-15
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Transcutaneous auricular vagus nerve stimulation will be delivered non-invasively through an auricular stimulation device targeting the auricular branch of the vagus nerve. Stimulation will be administered under researcher supervision using standardized stimulation parameters according to the device instructions and study protocol.
Exercise Program
Participants will perform a standardized exercise program for chronic neck pain including postural correction, deep cervical flexor activation, cervical mobility, scapular stabilization, and stretching exercises. Exercises will be performed under researcher supervision during the intervention period.
Sound-sham taVNS
Sound-sham transcutaneous auricular vagus nerve stimulation (taVNS) will be administered using a sham configuration of the Nurosym device (Parasym Scientific Ltd., UK). The sham procedure will replicate the appearance, electrode placement, duration, and auditory cues of active taVNS without delivering electrical stimulation. The device will produce acoustic signals mimicking those associated with active stimulation, while no electrical current will be delivered through the auricular electrodes. Each sham session will last 30 minutes. This procedure
Locations (1)
Kutahya Health Sciences University Physical Therapy and Rehabilitation Research Center
Kütahya, Türkiye, Turkey (Türkiye)