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 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.

Conditions

Chronic Neck Pain

Keywords

CHRONIC PAIN; VAGAL NERVE STIMULATION; EXERCISE

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

  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.

  Baseline and immediately after completion of the 6 weeks intervention.

Secondary Outcomes (2)

• 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.

Study Arms (3)

taVNS Before Exercise

EXPERIMENTAL

Participants will receive transcutaneous auricular vagus nerve stimulation before performing the standardized exercise program.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Other: Exercise Program

taVNS After Exercise

EXPERIMENTAL

Participants will first perform the standardized exercise program and will subsequently receive transcutaneous auricular vagus nerve stimulation.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Other: Exercise Program

Exercise only

ACTIVE COMPARATOR

Participants will receive the standardized exercise program without transcutaneous auricular vagus nerve stimulation.

Other: Exercise Program

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.

taVNS After Exercise; taVNS Before Exercise

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.

Exercise only; taVNS After Exercise; taVNS Before Exercise

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

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
• 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): September 14, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)