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Effect of Vagus Nerve Stimulation on Trapezius Trigger Point

NCT07045324 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-01

No results posted yet for this study

Summary

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).

Conditions

  • Myofascial Pain Syndrome
  • Trigger Points

Interventions

DEVICE

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.

PROCEDURE

Ischemic Compression

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

BEHAVIORAL

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).

Sponsors & Collaborators

  • Bahçeşehir University

    lead OTHER

Principal Investigators

  • Hasankerem Alptekin, Prof.DR · Bahçeşehir University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-05-15
Completion
2025-06-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045324 on ClinicalTrials.gov