Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea

Обзор

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

Подробное описание

Primary dysmenorrhea is a common, disregarded, underdiagnosed, and inadequately treated complaint of both young and adult females. It negatively impacts the quality of life of young females, forming the main reason behind their absenteeism from school or work, and causing limitation of daily activities and psychological stress.

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.

Вмешательства

• Другое 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.
• Другое 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 a

Первичные конечные точки

• Assessment of Menstrual pain intensity [Срок оценки: 3 months]
• Assessment of Menstrual Distress [Срок оценки: 3 months]
• Assessment of Menstrual symptoms [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Assessment of Quality of Life [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Damas Central Hospital — Al Mansurah

Идентификаторы

NCT: NCT07307222 · P.T.REC/012/005880

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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