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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea
Hadassah
Jerusalem, Israel
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.
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
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
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
Quality of life will be assessed using the Q-LES Questionnaire. The summary score will be determined as per the questionnaire manual
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
The convenience of device operation and usage will be determined using a series of specific questions posed to the subjects at visit 3.
Time frame: 3 days before the beginning of the menstrual period and up to three days after termination of the menstrual period.
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