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Completed

NCT Number: NCT03064945

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

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.

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hadassah

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIVIA

Device

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

iPulse Medical Ltd. (Livia)

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2017
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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