Effect of Vagus Nerve Stimulation on Trapezius Trigger Point

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-06-25

Brief Summary

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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).

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Detailed Description

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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)

Conditions

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Myofascial Pain Syndrome Trigger Points

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study employs a parallel assignment model with three distinct intervention arms. Ninety participants with trigger points in the upper trapezius muscle are randomly assigned to one of three groups (n=30 each): non-invasive vagus nerve stimulation (nVNS), ischemic compression (trigger point massage), or exercise (control). Each group receives their respective intervention over 10 sessions (3 times per week for 4 weeks). The parallel design ensures that participants remain in their assigned group throughout the study, with no crossover. Outcomes, including pain intensity, trigger point number, pain pressure threshold, neck function, well-being, and functional mobility, are assessed at baseline and post-intervention (week 4). Single blinding (outcomes assessor) is implemented to minimize bias in outcome measurements.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

This study employs single blinding, where the outcomes assessors are masked to the participants' group assignments. Participants are randomized into one of three groups (non-invasive vagus nerve stimulation, ischemic compression, or exercise), and the interventions are administered by unblinded study personnel. To minimize bias, assessors responsible for measuring outcomes, including pain intensity (Visual Analog Scale), number of trigger points, pain pressure threshold (algometer), neck function (Copenhagen Neck Functional Disability Scale), well-being (WHO-5 Well-Being Index), and functional mobility, are unaware of the intervention each participant receives. Participants and intervention providers are not blinded due to the nature of the interventions.

Study Groups

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Arm 1: Vagus Nerve Stimulation (nVNS)

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.

Group Type EXPERIMENTAL

Vagus Nerve Stimulation (nVNS)

Intervention Type DEVICE

Arm 1 (Vagus Nerve Stimulation (nVNS)) is an experimental intervention, as it tests a novel approach (non-invasive vagus nerve stimulation) for trigger point treatment.

Arm 2: Ischemic Compression

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.

Group Type ACTIVE_COMPARATOR

Ischemic Compression

Intervention Type PROCEDURE

Arm 2 (Ischemic Compression) is an active comparator, as it uses a standard treatment (trigger point massage) commonly applied for myofascial pain.

Exercise (Control)

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.

Group Type ACTIVE_COMPARATOR

Exercise (Control)

Intervention Type BEHAVIORAL

Arm 3 (Exercise (Control)) is explicitly labeled as the control group in your document, using a standard exercise program, which aligns with an active comparator (since it's an active intervention rather than a placebo or no intervention).

Interventions

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Vagus Nerve Stimulation (nVNS)

Arm 1 (Vagus Nerve Stimulation (nVNS)) is an experimental intervention, as it tests a novel approach (non-invasive vagus nerve stimulation) for trigger point treatment.

Intervention Type DEVICE

Ischemic Compression

Arm 2 (Ischemic Compression) is an active comparator, as it uses a standard treatment (trigger point massage) commonly applied for myofascial pain.

Intervention Type PROCEDURE

Exercise (Control)

Arm 3 (Exercise (Control)) is explicitly labeled as the control group in your document, using a standard exercise program, which aligns with an active comparator (since it's an active intervention rather than a placebo or no intervention).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No