Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea

NCT07307222 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005880
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (3)

• Assessment of Menstrual pain intensity

  Using the Visual Analog Scale (VAS), each female will be asked to rate her menstrual pain intensity by placing a mark along the line that corresponds to their perceived pain level now. The distance from the "no pain" end to the female's mark will be then measured in centimeters to quantify the pain intensity. A higher value indicates greater pain intensity.

  3 months

• Assessment of Menstrual Distress

  Using the Menstrual Distress Questionnaire (MEDI-Q), each participant will report physical, emotional, and social symptoms experienced during menstruation over the past 12 months and rate their impact on daily functioning and quality of life. The questionnaire uses a Likert scale to evaluate symptoms from the most recent cycle, and a total score is obtained by summing responses. Higher scores indicate greater menstrual distress and more substantial psychological and physical effects.

  3 months

• Assessment of Menstrual symptoms

  Using the WaLIDD score, each female will be asked to answer questions by putting a score regarding five key factors related to primary dysmenorrhea: Working ability, Location of pain, Intensity of pain, Days of pain, and the presence of Dysmenorrhea. Each factor is scored based on the female's experience during their menstrual cycle. The scores from all factors are combined to produce a total score, with a higher score indicating greater severity and impact of dysmenorrhea.

  3 months

Secondary Outcomes (1)

• Assessment of Quality of Life

  3 months

Study Arms (2)

Standard physical therapy program

ACTIVE COMPARATOR

It will include 18 females with primary dysmenorrhea who will receive standard physical therapy program for 3 months. Hot pack or heating pad will be applied to the lower abdomen or lower back area for 15-20 minutes per session, with 3 sessions per week over a period of 12 weeks. Six stretching exercises will be applied.The females will be instructed to perform the exercise 3 days/week.

Other: Standard physical therapy program

Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS)

EXPERIMENTAL

It will include 18 females with primary dysmenorrhea who will receive TTNS 30 minutes once a week for 12 weeks, in addition to the same physical therapy program.

Other: Standard physical therapy program; Other: Transcutaneous Tibial Nerve Stimulation (TTNS)

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS) OTHER

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.

Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS)

Standard physical therapy program OTHER

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.

Standard physical therapy program; Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females with a regular menstrual cycle, experiencing primary dysmenorrhea, confirmed by history and clinical diagnosis.
• Females aged between 18 and 35 years.
• Their BMI ranging from 20 to 29.9 kg/m².

You may not qualify if:

• Females engaging in regular physical exercises prior to the study course.
• A history of abdominal or pelvic surgery.
• Pelvic pathologies or diseases (e.g., polycystic ovary syndrome, endometriosis, adenomyomas, or uterine fibroids).
• Malignant or benign neoplasms in the uterus.
• Chronic diseases, including diabetes and/or rheumatoid arthritis.
• Presence of metal implants or pacemakers.
• Any contraindications to the use of electrical stimulation (e.g., open wounds, some skin conditions…. etc.).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Damas Central Hospital

Al Mansurah, Egypt

Location

Study Officials

• Afaf Mohamed Botla, PhD

  Assistant Professor, Cairo University

  STUDY CHAIR

• Hossam Eldeen Hussein Kamel, PhD

  Professor, Al-Azhar university

  STUDY DIRECTOR

• Mahitab Mohamed Yosri Ibrahim, PhD

  Lecturer, Cairo university

  STUDY DIRECTOR

Central Study Contacts

Aya Atef Mahmoud Sonbol, B.Sc

CONTACT

+20 109 155 0191; aya.soonbol@gmail.com

Mahitab Mohamed Yosri Ibrahim, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: December 21, 2025
• Primary Completion: March 21, 2026
• Study Completion: March 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

EG (1)