Effects of the Timing of Vagus Nerve Stimulation Combined With Exercise in Chronic Neck Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

This randomized controlled trial aims to investigate whether the timing of transcutaneous auricular vagus nerve stimulation (taVNS) relative to exercise influences clinical and autonomic outcomes in individuals with chronic neck pain.

Participants will be randomly allocated to one of three groups: taVNS applied before exercise, taVNS applied after exercise, or exercise alone. All groups will receive a standardized exercise program designed for chronic neck pain. The intervention will be conducted over a 6- to 8-week period.

The effects of the interventions will be evaluated using pain intensity, neck-related disability, sleep quality, heart rate variability, and exercise adherence. The study will determine whether applying taVNS before or after exercise provides additional benefits compared with exercise alone and whether the timing of stimulation influences treatment outcomes.

Eligibility

Primary outcome measure(s)

• Change in Pain Intensity - Numeric Pain Rating Scale — Baseline and immediately after completion of the 6 week interventions
  Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). Participants will rate their neck pain on an 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain intensity. Change from baseline will be compared between groups.
• Change in Neck-Related Disability - Neck Disability Index — Baseline and immediately after completion of the 6 weeks interventions.
  Neck-related disability will be assessed using the Neck Disability Index (NDI). The questionnaire consists of 10 sections scored from 0 to 5, producing a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability.
• Change in Sleep Quality - Pittsburgh Sleep Quality Index — Baseline and immediately after completion of the 6 weeks intervention.
  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates seven components of sleep and provides a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.

Trial sites (1)

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