Effect of Vagus Nerve Stimulation on Trapezius Trigger Point

Bahçeşehir University

Status: Active, not recruiting

Conditions: Trigger Points; Myofascial Pain Syndrome

Treatments: Procedure: Ischemic Compression; Behavioral: Exercise (Control); Device: Vagus Nerve Stimulation (nVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07045324

BAU-MA25

Details and patient eligibility

About

This randomized controlled trial aimed to evaluate the efficacy of non-invasive vagus nerve stimulation (nVNS) compared to ischemic compression (trigger point massage) and exercise in treating trigger points in the upper trapezius muscle. Ninety participants aged 18-55 with at least two trigger points were randomly assigned to three groups: nVNS, ischemic compression, or exercise (control). Interventions were administered over 10 sessions (3 times per week). Outcomes included pain intensity (Visual Analog Scale, VAS), trigger point number, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale, KBFÖS), well-being (WHO-5 Well-Being Index), and functional mobility. The nVNS group demonstrated statistically significant improvements in all outcomes compared to the other groups (p < 0.05).

Full description

Myofascial pain syndrome (MPS) is characterized by trigger points-hyperirritable spots in skeletal muscle associated with pain, stiffness, and reduced function. The upper trapezius muscle is a common site for trigger points, contributing to neck pain and disability. Traditional treatments include ischemic compression and exercise, but non-invasive vagus nerve stimulation (nVNS) has emerged as a promising modality due to its ability to modulate pain pathways and autonomic function.

This study investigated whether nVNS is more effective than ischemic compression or exercise in reducing pain and improving function in patients with trapezius trigger points. Participants were randomized into three groups (n=30 each)

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-55 years.
• Presence of at least two trigger points (active or latent) in the upper trapezius muscle, confirmed by palpation.
• Ability to provide informed consent.

Exclusion criteria

• History of cervical spine surgery or trauma.
• Neurological disorders (e.g., epilepsy, stroke).
• Pregnancy or breastfeeding.
• Use of pacemakers or other implanted electrical devices.
• Active infection or skin lesions at the stimulation site.
• Recent use of botulinum toxin or other trigger point injections.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Arm 1: Vagus Nerve Stimulation (nVNS)

Experimental group

Description:

Participants receive non-invasive auricular vagus nerve stimulation bilaterally to the concha and tragus using a TENS-based device (10 Hz, 300 µs, 20 minutes per session) for 10 sessions over 4 weeks, with intensity adjusted to patient comfort.

Treatment:

Device: Vagus Nerve Stimulation (nVNS)

Arm 2: Ischemic Compression

Active Comparator group

Description:

Participants receive manual trigger point massage (ischemic compression) applied to trapezius trigger points for 30-90 seconds per point, 3 times per week for 10 sessions.

Treatment:

Procedure: Ischemic Compression

Exercise (Control)

Active Comparator group

Description:

Participants perform a standardized exercise program including isometric neck exercises, upper trapezius stretching, and chin tuck exercises, conducted 3 times per week for 10 sessions.

Treatment:

Behavioral: Exercise (Control)