An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Exercise Program in Chronic Neck Pain, sponsored by Kutahya Health Sciences University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Treatment
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.
This study is designed as a three-arm, randomized, sham-controlled, parallel-group clinical trial investigating the effects of the timing of transcutaneous auricular vagus nerve stimulation (taVNS) relative to therapeutic exercise in individuals with chronic neck pain.
Participants will be randomly allocated in a 1:1:1 ratio to the PRE, POST, or CONTROL group. A double-dummy intervention schedule will be used to ensure that all participants undergo stimulation procedures both before and after each exercise session.
In the PRE group, participants will receive active taVNS before exercise and sound-sham stimulation after exercise. In the POST group, participants will receive sound-sham stimulation before exercise and active taVNS after exercise. In the CONTROL group, participants will receive sound-sham stimulation before and after exercise.
All groups will participate in the same standardized therapeutic exercise program, delivered three times weekly for six weeks, for a total of 18 supervised sessions. Each active or sham stimulation period will last approximately 30 minutes.
The primary outcome will be the change in neck pain intensity measured using the Numeric Pain Rating Scale (NPRS) from baseline to the end of the six-week intervention. Secondary assessments will investigate neck-related disability, cardiac autonomic regulation using heart rate variability indices (RMSSD/lnRMSSD), pressure pain sensitivity, exercise-induced hypoalgesia, and deep cervical flexor motor performance using the craniocervical flexion test (CCFT).
The study will examine the effects of active taVNS combined with exercise compared with sham stimulation and explore whether the timing of active stimulation before or after exercise influences clinical and mechanistic outcomes.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 81 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Kutahya Health Sciences University is the lead sponsor of 219 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive active taVNS before standardized therapeutic exercise and sound-sham stimulation after exercise, three times weekly for six weeks.
Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) · Other: Exercise Program
Participants receive sound-sham stimulation before standardized therapeutic exercise and active taVNS after exercise, three times weekly for six weeks.
Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) · Other: Exercise Program
Participants receive sound-sham stimulation both before and after standardized therapeutic exercise, three times weekly for six weeks.
Other: Exercise Program · Device: Sound-sham 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.
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 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
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.
Time frame: Baseline and immediately after completion of the 6 week interventions
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.
Time frame: Throughout the 6-8-week intervention period.
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.
Time frame: Baseline and immediately after completion of the 6 weeks intervention.
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.
Time frame: Baseline and immediately after completion of the 6 weeks interventions.
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.
Time frame: Baseline and immediately after completion of the 6 weeks intervention.
Change in Pressure Pain Threshold (PPT)
Pressure pain threshold (PPT) will be assessed using a digital pressure algometer at two anatomical sites: (1) the upper trapezius muscle, at the midpoint between the C7 spinous process and the lateral border of the acromion, on the predominantly painful side; and (2) the muscle belly of the tibialis anterior on the dominant lower limb, representing a remote assessment site. Three consecutive measurements will be obtained at each site, with 30-second intervals, and the mean value will be used for analysis. Higher PPT values indicate lower pressure pain sensitivity. Changes in local and remote PPT from baseline to Week 6 will be evaluated.
Time frame: Baseline and immediately after completion of the 6 weeks intervention.
Change in Deep Neck Flexor Endurance Test (DNFET) Performance
Cervical flexor muscle endurance will be assessed using the Deep Neck Flexor Endurance Test (DNFET). Participants will be positioned supine and instructed to perform a chin-tuck movement followed by lifting the head approximately 2.5 cm from the examination table while maintaining craniocervical flexion. The duration for which the participant can maintain the correct position will be recorded in seconds using a stopwatch. The test will be terminated when the participant is unable to maintain the required position, loses the chin-tuck posture, or stops because of pain or fatigue. Higher endurance times indicate better cervical flexor muscle endurance performance. Changes from baseline to Week 6 will be compared across the three intervention groups.
Time frame: Baseline and immediately after completion of the 6 weeks intervention.
Change in Exercise-Induced Hypoalgesia (EIH)
Exercise-induced hypoalgesic responses will be assessed using pressure pain threshold (PPT) measurements at two anatomical sites: the upper trapezius muscle on the predominantly painful side (local site) and the tibialis anterior muscle on the dominant lower limb (remote site). During the first and final intervention sessions, PPT will be measured immediately before and after the standardized exercise program, following the initial active or sound-sham stimulation period and before the second stimulation period. Three measurements will be obtained at each anatomical site, with 30-second intervals, and the mean will be calculated. The exercise-associated hypoalgesic response will be expressed as the difference between post-exercise and pre-exercise PPT values (ΔPPT = PPTpost - PPTpre). Positive values indicate increased pressure pain thresholds following exercise.
Time frame: First and final intervention sessions (Week 1 and Week 6).
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 7 months is below that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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