Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea

Kafrelsheikh University

Status: Enrolling

Conditions: Transcutaneous Tibial Nerve Stimulation; Women; Primary Dysmenorrhea

Treatments: Drug: Traditional treatment (Nonsteroidal anti-inflammatory drugs); Other: Transcutaneous tibial nerve stimulation (TTNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07352982

KFSIRB200-685

Details and patient eligibility

About

This study aims to investigate the effects of transcutaneous tibial nerve stimulation (TTNS) on women with primary dysmenorrhea (PD).

Full description

Dysmenorrhea is defined as painful menstrual cramps of uterine origin, and considered as one of the most common gynecological disorders among females of childbearing age.

Primary dysmenorrhea (PD) typically manifests within 6-12 months following menarche. It is not associated with organic lesions but is primarily attributed to uterine smooth muscle spasms and vasoconstriction, which are induced by elevated prostaglandin levels.

Additionally, the use of transcutaneous tibial nerve stimulation (TTNS), which consists of the stimulation of the posterior tibial nerve in the superomedial region of the ankle, may be a promising treatment option. The hypogastric sympathetic plexus (L4-L5) and the pelvic parasympathetic plexus (S2-S4) have the same medullar level as the posterior tibial nerve (L4-S3). Thus, inhibitory and excitatory impulses that control the function of the pelvic viscera at the level of the spinal cord can be rebalanced with their stimulation.

Enrollment: 32 estimated patients

Sex: Female

Ages: 20 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ranges from 20-25 years old.
• Body mass index (BMI) doesn't exceed 30 kg/m2.
• Patients referred from a Gynecologist with a diagnosis of Primary Dysmenorrhea (PD).
• Patients have regular menstrual cycles.
• Patients suffer from pain located in the suprapubic area, abdomen, lower lumbar area, perineum, and/or medial aspect of the thighs during at least half of their annual menstrual cycles and/or in the last 3 cycles.

Exclusion criteria

• Patients diagnosed with gynecological pathology.
• Patients taking oral contraceptives or had an intrauterine device implanted.
• Patients had bad obstetric situations or diseases that could interfere with participation.
• Patients have certain disorders including uncorrected coagulopathies, severe comorbid disorder, cancer in the last 5 years or at present, presence of erosions on the inner aspect of the ankle, severe mental disorders, or neuropathies affecting the lower limb.
• Patients who are smoking or taking oral sedatives.
• Patients had undergone surgery or childbirth in the last 6 months.
• Patients who are pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Study group (group A)

Experimental group

Description:

Patients will receive the transcutaneous tibial nerve stimulation (TTNS) and traditional treatment (Nonsteroidal anti-inflammatory drugs) for three sessions a week for four consecutive weeks.

Treatment:

Other: Transcutaneous tibial nerve stimulation (TTNS)

Control group (group B)

Active Comparator group

Description:

Patients will receive the placebo transcutaneous tibial nerve stimulation (TTNS) and traditional treatment (Nonsteroidal anti-inflammatory drugs) for three sessions a week for four consecutive weeks.

Treatment:

Drug: Traditional treatment (Nonsteroidal anti-inflammatory drugs)