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Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation in Females With Primary Dysmenorrhea
Sponsor: Riphah International University
Summary
Primary dysmenorrhea is a common gynecological condition characterized by painful menstrual cramps that can negatively affect daily activities and quality of life. Non-invasive neuromodulation techniques, including Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), have shown potential for pain management and modulation of autonomic nervous system function. However, limited evidence exists regarding the comparative and combined effects of these interventions. This randomized controlled trial aims to evaluate the comparative and combined effects of TTNS and taVNS on pain, autonomic function, menstrual symptoms, and NSAID consumption in females with primary dysmenorrhea. Eligible participants will be randomly assigned to one of four groups: TTNS, taVNS, combined TTNS + taVNS, or sham stimulation. Outcome measures will be assessed before and after the intervention period by a blinded assessor.
Official title: Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation on Pain and Autonomic Function in Females With Primary Dysmenorrhea
Key Details
Gender
FEMALE
Age Range
14 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-09
Completion Date
2027-07-31
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Tibial Nerve Stimulation (TTNS)
Electrical stimulation will be delivered through a TENS device using surface electrodes placed over the posterior tibial nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
Electrical stimulation delivered through a TENS device using surface electrodes placed on the auricular branch of the vagus nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
TTNS+TaVNS
Electrical stimulation delivered through a TENS device to both the posterior tibial nerve and the auricular branch of the vagus nerve sequentially according to the study protocol. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
Sham Stimulation
Sham stimulation delivered using the same TENS device and electrode placement as the active intervention but without therapeutic electrical stimulation. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.