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

NCT06233786 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-31

No results posted yet for this study

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 25-28 and 1-3 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 immediately after treatment in GI1 and GC, and at the beginning of the next bleeding phase, being 28 days after the intervention in the case of GI1 and GC, and 7 days after the intervention in the case of GI2, as well as 28 days after in this last.

Conditions

  • Primary Dysmenorrhea

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

This intervention is performed using a TENS with an asymmetric biphasic wave of 200 µs width, frequency of 100Hz and maximum intensity tolerated by the participant, adapting to avoid accommodation. The intervention will be carried out for 30 minutes, once a day, and 2 days a week, with 48-72 hours between both interventions. Regarding the electrodes, 4 adhesive electrodes (5.0x5.0) will be placed, 2 in the lower lumbar region and two in the parasacral region (S2-S4).

Sponsors & Collaborators

  • Naiara Benítez Aramburu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Spain

Study Locations

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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 NCT06233786 on ClinicalTrials.gov