Chronic Neck PainNCT07769034
Effects of the Timing of Vagus Nerve Stimulation Combined With Exercise in Chronic Neck Pain
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Exercise Program in people with Chronic Neck Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2026to 15 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- No contraindication to transcutaneous auricular vagus nerve stimulation.
- Willingness to provide written informed consent.
- Willingness to participate regularly in the planned exercise and assessment sessions.
Who cannot join
- Cervical radiculopathy or specific neurological findings.
- Previous cervical spine surgery.
- Serious cardiovascular disease.
- Serious neurological or systemic disease.
- Pregnancy.
- Orthopedic or musculoskeletal conditions preventing participation in exercise.
- Cognitive or communication problems that prevent completion of the assessment instruments.
- Inability or unwillingness to comply with the study protocol or attend scheduled sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Physical Therapy and Rehabilitation Research Center
Kütahya, Türkiye, 43100
Ismail SARACOGLU, PhD, 002742651300 ext. 1499, ismail.saracoglu@ksbu.edu.tr
Batuhan YUKSEL, Msc.
About this study
Official title: Does Timing Matter? Effects of Transcutaneous Auricular Vagus Nerve Stimulation Before and After Exercise in Chronic Neck Pain: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Chronic Neck Pain
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Exercise Program, Sound-sham taVNS
- Keywords
- CHRONIC PAIN, VAGAL NERVE STIMULATION, EXERCISE
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
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 ProgramOther
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 taVNSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| PRE-taVNS | Experimental | Participants receive active taVNS before standardized therapeutic exercise and sound-sham stimulation after exercise, three times weekly for six weeks. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Other: Exercise Program |
| POST-taVNS | Experimental | Participants receive sound-sham stimulation before standardized therapeutic exercise and active taVNS after exercise, three times weekly for six weeks. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Other: Exercise Program |
| CONTROL | Sham comparator | Participants receive sound-sham stimulation both before and after standardized therapeutic exercise, three times weekly for six weeks. Receives: Other: Exercise Program; Device: Sound-sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the 6 week interventions
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First and final intervention sessions (Week 1 and Week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Parasym Ltd.
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769034
- Sponsor's protocol ID
- BatuPHD
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No