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Active Not RecruitingNCT07045324

Effect of Vagus Nerve Stimulation on Trapezius Trigger Point

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Bahçeşehir University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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).

Detailed 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)

Conditions

Interventions

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

Timeline

Start date
2025-01-15
Primary completion
2025-05-15
Completion
2025-06-25
First posted
2025-07-01
Last updated
2025-07-01

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07045324. Inclusion in this directory is not an endorsement.