Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea

Cairo University (CU)

Status: Not yet enrolling

Conditions: Primary Dysmenorrhea

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07307222

P.T.REC/012/005880

Details and patient eligibility

About

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

Full description

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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Standard physical therapy program

Active Comparator group

Description:

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.

Treatment:

Other: Standard physical therapy program

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

Experimental group

Description:

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.

Treatment:

Other: Standard physical therapy program

Other: Transcutaneous Tibial Nerve Stimulation (TTNS)