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

NAActive, not recruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

September 1, 2025

Study Completion Date

February 28, 2026

Conditions
Migraine
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.

Trial Locations (1)

Unknown

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, Lahore

All Listed Sponsors
lead

Superior University

OTHER