Non-invasive neuromodulation for menstrual pain relief in women
Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial
This study is testing whether a non-invasive treatment using electrical nerve stimulation can help women with painful periods feel better during different phases of their menstrual cycle.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Escoles Universitaries Gimbernat Academic / other |
| Locations | 1 site (Torrelavega, Cantabria) |
| Trial ID | NCT06233786 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in adult women suffering from primary dysmenorrhea. Participants will be divided into groups based on the timing of TENS application during their menstrual cycle: during the bleeding phase and the luteal phase. A control group will receive similar treatment without active TENS stimulation. Pain levels will be assessed using various scales before, immediately after, and at subsequent menstrual cycles to determine the efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adult women with regular menstrual cycles and pain levels greater than 3 on the NPRS scale.
Not a fit: Patients who are pregnant, breastfeeding, or have specific gynecological or neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and effective pain management option for women suffering from primary dysmenorrhea.
How similar studies have performed: Other studies have shown promise with TENS for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Adult women * Pain greater than 3 on the NPRS scale * Women with regular menstrual cycle, considered regular between 25-30 days Exclusion criteria: * Pregnancy or breastfeeding * Used of intrauterine device * Diagnosed gynaecological pathology: endometriosis, polycystic ovaries, uterine fibroid, adenomyosis, fibrosis, uterine malformation, pelvic inflammation, scars, SDT... * Skin lesions that prevent the placement of the electrodes * Other diagnosed pathologies that contraindicate the application of TENS, neurological pathologies, or cardiovascular diseases * Absence or doubling of bleeding in one month * Taking analgesic medications and/or NSAIDs
Where this trial is running
Torrelavega, Cantabria
- Naiara Benítez Aramburu — Torrelavega, Cantabria, Spain (Recruiting)
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.