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COMPLETED
NCT06233786
NA

The Effectivenes of Non-invasive Neuromodulation in Adult Women With Primary Dysmenorrhea, Through the TENS Stimulation at Different Times of Menstrual Cycle in Each Group

Sponsor: Naiara Benítez Aramburu

View on ClinicalTrials.gov

Summary

The effectiveness of non-invasive neuromodulation in adult women with primary dysmenorrhea, through the TENS stimulation at different times in each group: during the bleeding phase (G1), between days 1 and 3 of menstrual cycle, and in the luteal phase (GI2), between days 17 to 24 of menstrual cycle. The control group (CG) will be treated just like GI1, during the bleeding phase, but without the TENS transmitting the current. Participants will be evaluated by the NPRS, MPQ, SF12, CVM-22, HADS, PCS, PSQI and UDP in the first day of menstruation. Aditionally, GI1 and GC women, will be evaluated inmediatelly after the first sesion of treatment.

Official title: Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-02-22

Completion Date

2026-09-23

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase

Transcutaneous electrical nerve stimulation will be applied for 30 minutes on the first and third days of menstrual bleeding using a TENS device with 4 electrodes placed bilaterally along the midline of the lumbosacral region.

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase

Transcutaneous electrical nerve stimulation will be applied for 30 minutes on cycle days 21 and 23, corresponding to the mid-luteal phase, using a TENS device with 4 electrodes placed bilaterally along the midline of the lumbosacral region.

DEVICE

Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase

The same procedure will be performed during the bleeding phase, but without delivering electrical current.

Locations (1)

Naiara Benítez Aramburu

Torrelavega, Cantabria, Spain