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

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064945
• Other study ID #: LIVIA-01
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2017
• Est. completion date: April 25, 2018

Study information

• Verified date: May 2017
• Source: iPulse Medical Ltd. (Livia)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 25, 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Women between the age 18 to 45 years

2. Women reporting painful menstruation during the last 3 menstrual cycles.

3. Pain VAS score of at least 60 based on previous menstrual cycle

4. Subject is willing and able to comply with the study protocol and provide written informed consent to participate in the study.

5. 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:

1. Participation in any other investigational study within 30 days prior and/or at the date of subject consent.

2. 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.

3. Pregnant woman

4. A woman who is diagnosed with secondary dysmenorrhea associated with uterine myomas, endometriosis, adenomyosis, etc.

5. A woman who has cardiac condition with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Device:
• Livia
Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea

Locations

Country	Name	City	State
Israel	Hadassah	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
iPulse Medical Ltd. (Livia)

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SAFETY AND TOLERABILITY ENDPOINTS	The safety and tolerability endpoints of this study are Adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the study Duration of device use	3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
Primary	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	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.
Secondary	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.
Secondary	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.