NCT07352982

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 13, 2026

Last Update Submit

January 19, 2026

Conditions

Transcutaneous Tibial Nerve StimulationWomenPrimary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Prostaglandin level

    6 months after the procedure

  • Assessment of Quality of Life

    6 months after the procedure

Study Arms (2)

Study group (group A)

EXPERIMENTAL

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)

Control group (group B)

ACTIVE COMPARATOR

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)

Interventions

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.

Control group (group B)
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.

Study group (group A)

Eligibility Criteria

Age20 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen With Primary Dysmenorrhea
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University (Faculty of Physical Therapy)

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Central Study Contacts

Amira R Darwish, MBBCH

CONTACT

00201062565206amirarashad13@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. in Physical Therapy, Pharos University in Alexandria

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 20, 2026

Study Start

January 19, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)