Effect of Vagus Nerve Stimulation on Trapezius Trigger Point

NCT07045324 | Active Not Recruiting DMC

• 1 other identifier: BAU-MA25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Trigger points; Vagus Nerve Stimulation; Parasympathetic System

Outcome Measures

Primary Outcomes (5)

• Pain Intensity (VAS)(Visual Analog Scale )

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

  Baseline and post-intervention (week 4)

• Number of Trigger points

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

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

• Pain Pressure Threshold (Algometer)

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

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

• Neck Function (CNFDS(Copenhagen Neck Functional Disability)

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

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

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

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

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

Study Arms (3)

Arm 1: Vagus Nerve Stimulation (nVNS)

EXPERIMENTAL

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.

Device: Vagus Nerve Stimulation (nVNS)

Arm 2: Ischemic Compression

ACTIVE COMPARATOR

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.

Procedure: Ischemic Compression

Exercise (Control)

ACTIVE COMPARATOR

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.

Behavioral: Exercise (Control)

Interventions

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.

Arm 1: Vagus Nerve Stimulation (nVNS)

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.

Arm 2: Ischemic Compression

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).

Exercise (Control)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahçeşehir University, Physiotherapy and Rehabilitation

Istanbul, Helthy, 34353, Turkey (Türkiye)

Location

Related Publications (3)

• Xu A, Huang Q, Rong J, Wu X, Deng M, Ji L. Effectiveness of ischemic compression on myofascial trigger points in relieving neck pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(4):783-798. doi: 10.3233/BMR-220045.

  PMID: 36872769 RESULT

• Moraska AF, Schmiege SJ, Mann JD, Butryn N, Krutsch JP. Responsiveness of Myofascial Trigger Points to Single and Multiple Trigger Point Release Massages: A Randomized, Placebo Controlled Trial. Am J Phys Med Rehabil. 2017 Sep;96(9):639-645. doi: 10.1097/PHM.0000000000000728.

  PMID: 28248690 RESULT

• Alghadir AH, Iqbal A, Anwer S, Iqbal ZA, Ahmed H. Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Male Patients with Upper Trapezius Active Myofascial Trigger Points. Biomed Res Int. 2020 Mar 10;2020:9361405. doi: 10.1155/2020/9361405. eCollection 2020.

  PMID: 32258159 RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Vagus Nerve Stimulation; Acupressure; Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hasankerem Alptekin, Prof.DR

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Mcs. Physiotherapy and Rehabilitation Department ,Bahçeşehir University

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 1, 2025
• Study Start: January 15, 2025
• Primary Completion: May 15, 2025
• Study Completion: June 25, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)