Ankle (posterior tibial) nerve stimulation for primary menstrual cramps
Effect of Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea
NA · Kafrelsheikh University · NCT07352982
This test tries gentle electrical stimulation of the posterior tibial nerve at the ankle to reduce menstrual cramp pain in women with primary dysmenorrhea aged 20–25.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 20 Years to 25 Years |
| Sex | Female |
| Sponsor | Kafrelsheikh University (other) |
| Locations | 1 site (Kafr ash Shaykh, Kafrelsheikh) |
| Trial ID | NCT07352982 on ClinicalTrials.gov |
What this trial studies
This interventional trial enrolls women aged 20–25 with primary dysmenorrhea and BMI ≤30 who have regular menstrual cycles. Participants receive transcutaneous tibial nerve stimulation (TTNS) applied at the superomedial ankle region, with outcomes compared to traditional NSAID treatment. The approach is based on shared spinal segments between the posterior tibial nerve and pelvic autonomic nerves, which may rebalance spinal impulses that influence uterine pain. Main outcomes will focus on menstrual pain intensity and related functional measures across menstrual cycles.
Who should consider this trial
Good fit: Ideal candidates are women aged 20–25 with physician-diagnosed primary dysmenorrhea, regular menstrual cycles, BMI ≤30 kg/m2, not using hormonal contraception or an intrauterine device, and without pelvic pathology or lower‑limb neuropathies.
Not a fit: Patients with secondary dysmenorrhea due to gynecologic disease, those using hormonal contraceptives or an IUD, smokers, people with severe comorbidities or lower‑limb neuropathies, or those outside the age/BMI limits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, TTNS could offer a non-drug, low‑risk option to reduce menstrual cramp pain for women with primary dysmenorrhea.
How similar studies have performed: Tibial nerve stimulation has shown benefit in other pelvic conditions such as overactive bladder and some pelvic pain reports, but its use specifically for primary dysmenorrhea is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kafr ash Shaykh, Kafrelsheikh
- Kafrelsheikh University (Faculty of Physical Therapy) — Kafr ash Shaykh, Kafrelsheikh, Egypt (RECRUITING)
Study contacts
- Study coordinator: Amira R Darwish, MBBCH
- Email: amirarashad13@gmail.com
- Phone: 00201062565206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transcutaneous Tibial Nerve Stimulation, Women, Primary Dysmenorrhea