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

NCT07769034 | Not Yet Recruiting

• 1 other identifier: BatuPHD
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Neck Pain

Keywords

CHRONIC PAIN; VAGAL NERVE STIMULATION; EXERCISE

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and immediately after completion of the 6 week interventions

Secondary Outcomes (7)

• Exercise Adherence

  Throughout the 6-8-week intervention period.

• Change in Heart Rate Variability - RMSSD

  Baseline and immediately after completion of the 6 weeks intervention.

• Change in Neck-Related Disability - Neck Disability Index

  Baseline and immediately after completion of the 6 weeks interventions.

• Change in Sleep Quality - Pittsburgh Sleep Quality Index

  Baseline and immediately after completion of the 6 weeks intervention.

• Change in Pressure Pain Threshold (PPT)

  Baseline and immediately after completion of the 6 weeks intervention.

Study Arms (3)

PRE-taVNS

EXPERIMENTAL

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

POST-taVNS

EXPERIMENTAL

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

CONTROL

SHAM COMPARATOR

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

Interventions

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.

POST-taVNS; PRE-taVNS

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.

CONTROL; POST-taVNS; PRE-taVNS

Sound-sham taVNS DEVICE

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

CONTROL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead
• Parasym Ltd.: collaborator

Study Sites (1)

Kutahya Health Sciences University Physical Therapy and Rehabilitation Research Center

Kütahya, Türkiye, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Batuhan YUKSEL, Msc.

CONTACT

00905334350996; bthanyksel13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A double-dummy design will be implemented in which all participants receive device-based stimulation procedures both before and after exercise. Active taVNS and sound-sham stimulation will be administered using visually similar, coded electrode configurations. Participants and outcome assessors will remain blinded to group allocation. Blinding of intervention providers will also be maintained if the device coding and administration procedures permit. Allocation information will be managed by an independent researcher not involved in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)