Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous tibial nerve stimulation (TTNS), Traditional treatment (Nonsteroidal anti-inflammatory drugs).
- Who it may be relevant to
- Registry conditions: Transcutaneous Tibial Nerve Stimulation, Women, Primary Dysmenorrhea. Basic parameters: 20 years — 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Pain Intensity [Time frame: 6 months after the procedure]
Secondary outcome measures (2)
- Prostaglandin level [Time frame: 6 months after the procedure]
- Assessment of Quality of Life [Time frame: 6 months after the procedure]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kafrelsheikh University (Faculty of Physical Therapy) — Kafr ash Shaykh
Identifiers
NCT: NCT07352982 · KFSIRB200-685