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NCT Number: NCT07769034

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University Physical Therapy and Rehabilitation Research Center

Kütahya, Türkiye, 43100, Turkey (Türkiye)

Location contact

Batuhan YUKSEL, Msc.

PRINCIPAL_INVESTIGATOR

Ismail SARACOGLU, PhD

CONTACT

[email protected]

002742651300 ext. 1499

Merve Akdeniz LEBLEBİCİER, MD

SUB_INVESTIGATOR

About this study

Chronic neck pain is a common musculoskeletal condition associated with pain, functional limitations, sleep disturbances, and alterations in autonomic nervous system activity. Exercise therapy is one of the main conservative treatment approaches for chronic neck pain. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation method that aims to stimulate the auricular branch of the vagus nerve and may influence parasympathetic activity and pain modulation.

The purpose of this randomized controlled trial is to investigate whether the timing of taVNS relative to exercise influences clinical and physiological outcomes in individuals with chronic neck pain.

A total of 81 participants with chronic neck pain will be randomly allocated to three parallel groups. Participants in the first group will receive taVNS before performing a standardized exercise program. Participants in the second group will perform the same exercise program followed by taVNS. Participants in the control group will receive the exercise program alone.

The exercise program will include postural correction exercises, deep cervical flexor activation exercises, cervical mobility exercises, scapular stabilization exercises, and stretching exercises. The intervention period will last approximately 6-8 weeks.

Participants will be evaluated before and after the intervention period. Pain intensity will be assessed using the Numeric Pain Rating Scale, neck-related disability using the Neck Disability Index, sleep quality using the Pittsburgh Sleep Quality Index, and autonomic nervous system activity using heart rate variability, particularly the root mean square of successive differences (RMSSD). Exercise adherence and session attendance will also be recorded.

The study will compare changes in these outcomes among the three groups to determine whether the timing of taVNS relative to exercise influences the effectiveness of rehabilitation in individuals with chronic neck pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 program

Other

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.

Primary outcomes

  1. Change in Pain Intensity - Numeric Pain Rating Scale

    Time frame: 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.

  2. Change in Neck-Related Disability - Neck Disability Index

    Time frame: 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.

  3. Change in Sleep Quality - Pittsburgh Sleep Quality Index

    Time frame: 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.

Secondary outcomes

  1. Exercise Adherence

    Time frame: Throughout the 6-8-week intervention period.

    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.

  2. Change in Heart Rate Variability - RMSSD

    Time frame: Baseline and immediately after completion of the 6 weeks intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Batuhan YUKSEL, Msc.

CONTACT

[email protected]

00905334350996

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Does Timing Matter? Effects of Transcutaneous Auricular Vagus Nerve Stimulation Before and After Exercise in Chronic Neck Pain: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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