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NCT Number: NCT07352982

Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea

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

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Key information

Age range

20 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University (Faculty of Physical Therapy)

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Amira R Darwish, MBBCH

CONTACT

[email protected]

00201062565206

Fayiz F Elshamy, MD

SUB_INVESTIGATOR

Mostafa F Ellakany, MD

SUB_INVESTIGATOR

Muhammad F AbdulGalil, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous tibial nerve stimulation (TTNS)

Other

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.

Traditional treatment (Nonsteroidal anti-inflammatory drugs)

Drug

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.

Primary outcomes

  1. Pain Intensity

    Time frame: 6 months after the procedure

    Pain Intensity will be assessed using visual Analogue Scale (VAS). VAS consisted of a continuous 10 cm line that represents the pain intensity, ranging from zero; on the left side, which indicates no pain, or discomfort to 10; on the right side, which indicates the worst possible pain he could feel.

Secondary outcomes

  1. Prostaglandin level

    Time frame: 6 months after the procedure

    Serum Prostaglandin will be measured.

  2. Assessment of Quality of Life

    Time frame: 6 months after the procedure

    Quality of Life (QOL) will be assessed using the Arabic Version of the Short Form 36 Health Questionnaire. This questionnaire will be used for assessment of QOL. It is made up of 35 items that measure 8 dimensions of health-related QOL. In addition, it includes a change self-assessment item that is not used in scoring. The instrument items cover: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. The higher the score on the SF-36, the better the health.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira R Darwish, MBBCH

CONTACT

[email protected]

00201062565206

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Effect of Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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