Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea

Effect of 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).

Study Overview

• Status: Recruiting
• Conditions: Primary Dysmenorrhea; Women; Transcutaneous Tibial Nerve Stimulation
• Intervention / Treatment: Other: Transcutaneous tibial nerve stimulation (TTNS); Drug: Traditional treatment (Nonsteroidal anti-inflammatory drugs)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amira R Darwish, MBBCH; Phone Number: 00201062565206; Email: amirarashad13@gmail.com

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Recruiting
      • Kafrelsheikh University (Faculty of Physical Therapy)
      • Contact: Amira R Darwish, MBBCH; Phone Number: 00201062565206; Email: amirarashad13@gmail.com
      • Sub-Investigator: Fayiz F Elshamy, MD
      • Sub-Investigator: Muhammad F AbdulGalil, MD
      • Sub-Investigator: Mostafa F Ellakany, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group (group A); 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.	Other: Transcutaneous tibial nerve stimulation (TTNS); 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.
Active Comparator: Control group (group B); 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.	Drug: Traditional treatment (Nonsteroidal anti-inflammatory drugs); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	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.	6 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostaglandin level	Serum Prostaglandin will be measured.	6 months after the procedure
Assessment of Quality of Life	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.	6 months after the procedure

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: KFSIRB200-685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No