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Compare the Effectiveness of nVNS and TENS on Pain and Quality of Life in Patients of Migraine

NCT07055776 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-07-09

No results posted yet for this study

Summary

Migraine is a genetically influenced complex neurological disorder characterized by episodes of moderate-to-severe headaches, typically unilateral and frequently accompanied by nausea and heightened sensitivity to light and sound. The common type of migraine headaches is migraine without aura. Migraine has an approximate prevalence of 14.7%, making it the third most common disease in the world. This study aims to compare the effectiveness of non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS) in managing pain and improving quality of life (QOL) in patients with migraine.

Conditions

Interventions

COMBINATION_PRODUCT

non-invasive vagus nerve stimulation (nVNS)

Group 1 will receive non-invasive vagus nerve stimulation (nVNS) targeting the auricular branch of the vagus nerve (ABVN) using a TENS device with specialized ear clip electrodes. The electrodes will be placed on the cymba conchae or tragus region of the ear, where the ABVN is accessible. The stimulation parameters will be set to a frequency of 1 Hz (significantly reduced migraine headache), pulse width of 200-300 µs, and intensity adjusted to a strong but comfortable level without causing pain, applied for 15-30 minutes per session, 5 days a week for 12 weeks, based on protocols supported by evidence from studies such as Badran et al. (2018) and Yakunina et al. (2017), which demonstrated positive neuromodulatory effects through auricular stimulation. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.

COMBINATION_PRODUCT

non-invasive transcutaneous electrical nerve stimulation (TENS)

Group 2 will receive non-invasive transcutaneous electrical nerve stimulation (TENS) applied to the other areas to target other nerves stimulation (e.g., neck, upper trapezius, or occipital area). Surface electrodes will be placed paravertebrally, using a conventional TENS protocol: frequency of 20-25 Hz, pulse width of 200-300 µs, and intensity set to produce a strong but comfortable tingling sensation without muscle contraction. Each session will last 20-30 minutes, administered 5 days a week for 12 weeks. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.

Sponsors & Collaborators

  • Superior University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2025-09-01
Completion
2026-02-28

Countries

  • Pakistan

Study Locations

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Entities

Diseases

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 NCT07055776 on ClinicalTrials.gov