Status:
COMPLETED
Transcutaneous Tibial Nerve Stimulation as Treatment for Women With Primary Dysmenorrhea
Lead Sponsor:
University of Salamanca
Conditions:
Dysmenorrhea Primary
Eligibility:
FEMALE
18-43 years
Phase:
NA
Brief Summary
The goal of this study is to verify whether transcutaneous stimulation of the posterior tibial nerve improves pain, quality of life and sleep deficiency in patients with pain related to their menstrua...
Eligibility Criteria
Inclusion
- Women aged between 18 and 43.
- Women with regular menstrual cycles (range between 21 and 35 days).
- Women with a visual analogue scale (VAS) between 4 and 10 (moderate to severe pain) during at least 50% of annual menstrual cycles and / or during the last 3 cycles in the suprapubic area, abdomen, lower lumbar area , perineum and / or medial side of the thighs during the first and / or second day of your menstrual cycle.
- Sign the informed consent document to participate in the study.
Exclusion
- Women on hormonal therapy or who have an Intrauterine Device implanted.
- Women diagnosed of secondary dysmenorrhea by their gynecologist (endometriosis, ovarian cyst, etc.) in the last 18 months.
- Women who have underwent a surgery during the study.
- Women who have underwent abdominal and pelvic surgery or who have given birth (vaginal or cesarean section) in the last 6 months.
- Women with lesions on the skin of the upper-internal face of the ankles (scars, erosions or cysts).
- Women who are pregnant or planning a pregnancy.
- Women with pacemakers, uncorrected coagulopathies, severe comorbid disorder, cancer (in the last 5 years or now), severe mental disorders or neuropathies that affect the nerves of the pelvis or lower extremities.
- Physiotherapy or electrotherapy treatments that are related to the pathology or study areas of the month prior to the start of the study.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04896814
Start Date
May 25 2021
End Date
April 30 2022
Last Update
February 13 2024
Active Locations (1)
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1
USalamanca
Salamanca, Spain, 37007