About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of chronic neck pain confirmed by a physical medicine and rehabilitation physician.
Age between 18 and 65 years.
Neck pain persisting or recurring for at least 3 months.
Ability to participate in the exercise program included in the study protocol.
Disqualifiers
Cervical radiculopathy or specific neurological findings.
Previous cervical spine surgery.
Serious cardiovascular disease.
Serious neurological or systemic disease.
Trial design
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
DeviceTranscutaneous 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
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Pain Intensity - Numeric Pain Rating Scale
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
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
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.
Secondary outcomes
Exercise Adherence
Exercise adherence will be assessed based on participant attendance at scheduled treatment sessions. Adherence will be expressed as the number and/or percentage of completed sessions relative to the total number of planned sessions.
Change in Heart Rate Variability - RMSSD
Autonomic nervous system activity will be assessed using heart rate variability. The root mean square of successive differences between normal heartbeats (RMSSD), expressed in milliseconds, will be used as the primary heart rate variability parameter. Higher RMSSD values generally represent greater parasympathetic/vagal activity.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: