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NCT Number: NCT07045324

Effect of Vagus Nerve Stimulation on Trapezius Trigger Point

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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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Trigger Points

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahçeşehir University, Physiotherapy and Rehabilitation

Istanbul, Helthy, 34353, Turkey (Türkiye)

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Vagus Nerve Stimulation (nVNS)

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.

Ischemic Compression

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)

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).

Primary outcomes

  1. Pain Intensity (VAS)(Visual Analog Scale )

    Time frame: Baseline and post-intervention (week 4)

    Measured using the Visual Analog Scale (0-10 ), where 0 indicates no pain and 10 indicates worst possible pain.

  2. Number of Trigger points

    Time frame: Measurements were taken pre- and post-intervention.(week 4)

    Count of active and latent trigger points in the upper trapezius muscle, assessed by palpation.

  3. Pain Pressure Threshold (Algometer)

    Time frame: Measurements were taken pre- and post-intervention. (week 4)

    Measured using a digital algometer (kg/cm²) at trigger point sites to assess pain sensitivity.

  4. Neck Function (CNFDS(Copenhagen Neck Functional Disability)

    Time frame: Measurements were taken pre- and post-intervention. (week 4)

    Assessed using the Copenhagen Neck Functional Disability Scale, evaluating neck-related disability (0-30, higher scores indicate greater disability).

  5. WHO-5(World Health Organization-Five Well-Bing Index)

    Time frame: Measurements were taken pre- and post-intervention. (week 4)

    Description: Measured using the WHO-5 Well-Being Index, a 5-item scale (0-25, higher scores indicate better well-being)

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

A Comparative Study on the Effect of Vagus Nerve Stimulation and Ischemic Compression on Trapezius Trigger Points

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

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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