The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.

Study Overview
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Brief Summary
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This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement will be used to publish and promote recruitment. The study will include 3 visits: Screening visit and two consecutive visits each one after monthly menstrual period. Treatment will be self-administrated and during the study, the subjects will be requested to complete home diaries.

Official Title
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A Randomized, Controlled, Multi-Center, CROSSOVER, Prospective, Double-blind Clinical Study to Assess the Effectiveness and Safety of Livia® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Device: Livia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the age 18 to 45 years Women reporting painful menstruation during the last 3 menstrual cycles. Pain VAS score of at least 60 based on previous menstrual cycle Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study. Subject must agree to consistently use effective contraception throughout the study. (Subject not treated with oral contraception should use any contraception other than oral). Exclusion Criteria: Participation in any other investigational study within 30 days prior and/or at the date of subject consent. Woman with a significant medical condition such as: cancer, diabetes (Type I and II), irritable bowel disease IBD, immunodeficiency, autoimmune disease, etc. that in the investigator opinion, participation in the study would place the patient at an unacceptable risk. Pregnant woman A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc. A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Shame device<br> | Device: Livia<br>* Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea<br>|
| Experimental: Livia® Transcutaneous Electrical Nerve Stimulation (TENS)<br> | Device: Livia<br>* Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between the reported Visual Analogue Scale before and after applying the device (active or sham). | Each participant will rank the severity of her dysmenorrhea symptoms before and after the device use on the VAS scale from 0 to 100, where 0 determines- No pain and 100 determines Very painful. Then, the difference between the two measurements will be calculated. | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of pain relievers during the menstrual period | Usage of pain relievers during the menstrual period as recorded in the subjects' diaries. This will be measured by the number of pain relief pills taken during the entire menstrual period | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | 
| Quality of life | Quality of life will be assessed using the Q-LES Questionnaire. The summary score will be determined as per the questionnaire manual | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | 
| The convenience of device operation | The convenience of device operation and usage will be determined using a series of specific questions posed to the subjects at visit 3. | 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Livia TENS, safety and efficacy, menstruating women