Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea
NCT ID: NCT07307222
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-12-21
2026-03-31
Brief Summary
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Detailed Description
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The Transcutaneous Tibial Nerve Stimulation (TTNS) is a rather new method acclaimed to be viable for chronic pelvic pain management. As it uses surface electrodes, it can be self-administrated by patients. Research is lacking regarding the effect of TTNS on primary dysmenorrhea. Thus, this study will be designed to examine the effect of TTNS on menstrual pain and distress as well as quality of life in females with primary dysmenorrhea. Study results will have valuable benefits in the physical therapy field, scientific research and medical and health organizations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard physical therapy program
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.
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.
Standard physical therapy program + Transcutaneous Tibial Nerve Stimulation (TTNS)
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Females aged between 18 and 35 years.
* Their BMI ranging from 20 to 29.9 kg/m².
Exclusion Criteria
* 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.).
18 Years
35 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Aya Atef Mahmoud Sonbol
Principal Investigator
Principal Investigators
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Afaf Mohamed Botla, PhD
Role: STUDY_CHAIR
Assistant Professor, Cairo University
Hossam Eldeen Hussein Kamel, PhD
Role: STUDY_DIRECTOR
Professor, Al-Azhar university
Mahitab Mohamed Yosri Ibrahim, PhD
Role: STUDY_DIRECTOR
Lecturer, Cairo university
Locations
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Damas Central Hospital
Al Mansurah, , Egypt
Countries
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Central Contacts
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Mahitab Mohamed Yosri Ibrahim, PhD
Role: CONTACT
Facility Contacts
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Aya Atef Mahmoud Sonbol, B.Sc
Role: primary
Other Identifiers
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P.T.REC/012/005880
Identifier Type: -
Identifier Source: org_study_id