Transcutaneous Tibial Nerve StimulationNCT07352982
Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea
A study testing Transcutaneous tibial nerve stimulation (TTNS) and Traditional treatment (Nonsteroidal anti-inflammatory drugs) in people with Transcutaneous Tibial Nerve Stimulation and Women, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to investigate the effects of transcutaneous tibial nerve stimulation (TTNS) on women with primary dysmenorrhea (PD). Read more about this study
- Who is it for?
- Ages 20 to 25 years, women only
- Conditions the study is for
- Transcutaneous Tibial Nerve Stimulation, Women, Primary Dysmenorrhea
- What is being tested?
- Transcutaneous tibial nerve stimulation (TTNS) and Traditional treatment (Nonsteroidal anti-inflammatory drugs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University (Faculty of Physical Therapy)
Kafr ash Shaykh, Kafrelsheikh, 33516
Amira R Darwish, MBBCH, 00201062565206, amirarashad13@gmail.com
Fayiz F Elshamy, MD
About this study
Official title: 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).
Read the 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.
- Being tested
- Transcutaneous tibial nerve stimulation (TTNS), Traditional treatment (Nonsteroidal anti-inflammatory drugs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Traditional treatment (Nonsteroidal anti-inflammatory drugs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the procedure
Secondary outcomes (2)
Prostaglandin level
Serum Prostaglandin will be measured.
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.
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start19 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Tibial Nerve StimulationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Rashad Mohamed Darwish, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352982
- Sponsor's protocol ID
- KFSIRB200-685
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07352982
- Acronym / sponsor ID
- KFSIRB200-685
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of transcutaneous tibial nerve stimulation (TTNS) on women with primary dysmenorrhea (PD).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (group A) | Experimental | 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. |
| Control group (group B) | Active comparator | 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. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Study group (group A) |
| 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. | Drug | Control group (group B) |
Primary outcome
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.
2 secondary outcomes
Prostaglandin level
Time frame: 6 months after the procedure
Assessment of Quality of Life
Time frame: 6 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous tibial nerve stimulation (TTNS) and Traditional treatment (Nonsteroidal anti-inflammatory drugs) in people with Transcutaneous Tibial Nerve Stimulation and Women, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira R Darwish, MBBCH (00201062565206, amirarashad13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 6 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.