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Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea

NCT07307222 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-29

No results posted yet for this study

Summary

This study will be conducted to evaluate the effect of Transcutaneous Tibial Nerve Stimulation (TTNS) on primary dysmenorrhea.

Conditions

  • Primary Dysmenorrhea

Interventions

OTHER

Standard physical therapy program

The standard physical therapy program will include the application of a hot pack or heating pad to the lower abdomen or lower back for 15-20 minutes per session, three times per week for a duration of 12 weeks. The temperature of the hot pack will be maintained between 40°C and 45°C (104°F-113°F). In addition, participants will perform six stretching exercises for 30-45 minutes per session, also three times per week for 12 weeks.

OTHER

Transcutaneous Tibial Nerve Stimulation (TTNS)

The TTNS intervention will be applied once a week for 30-minute sessions over 12 weeks. The EV-906 electrostimulation device will be used for the treatment. A symmetrical biphasic current will be applied in continuous mode at 20 Hz and 200 μs. The patient will be in a supine position with knees flexed and abducted at a 90-degree angle. Stimulation will be applied to both legs using two adhesive electrodes placed cranially to the internal malleolus of each leg, with additional electrodes placed at the ipsilateral calcaneus. The stimulation intensity will be regulated between 1 and 30 mA.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Afaf Mohamed Botla, PhD · Assistant Professor, Cairo University

  • Hossam Eldeen Hussein Kamel, PhD · Professor, Al-Azhar university

  • Mahitab Mohamed Yosri Ibrahim, PhD · Lecturer, Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-21
Primary Completion
2026-03-21
Completion
2026-03-31

Countries

  • Egypt

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 NCT07307222 on ClinicalTrials.gov