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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03064945
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
iPulse Medical Ltd. (Livia)

Brief 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.


Condition or disease Intervention/treatment Phase
Dysmenorrhea Device: Livia Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Sham Comparator: Shame device Device: Livia
Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea

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




Primary Outcome Measures :
  1. The difference between the reported Visual Analogue Scale before and after applying the device (active or sham). [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
    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.


Secondary Outcome Measures :
  1. Usage of pain relievers during the menstrual period [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of 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

  2. Quality of life [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
    Quality of life will be assessed using the Q-LES Questionnaire. The summary score will be determined as per the questionnaire manual

  3. The convenience of device operation [ Time Frame: 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 and usage will be determined using a series of specific questions posed to the subjects at visit 3.


Other Outcome Measures:
  1. SAFETY AND TOLERABILITY ENDPOINTS [ Time Frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period. ]
    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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study on women that suffering from painful menstruation
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064945


Locations
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Israel
Hadassah
Jerusalem, Israel
Sponsors and Collaborators
iPulse Medical Ltd. (Livia)
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Responsible Party: iPulse Medical Ltd. (Livia)
ClinicalTrials.gov Identifier: NCT03064945    
Other Study ID Numbers: LIVIA-01
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by iPulse Medical Ltd. (Livia):
Livia TENS
safety and efficacy
menstruating women
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations