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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shame device | Sham Comparator |
| |
| Livia® Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livia | Device | Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea |
|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
This study on women that suffering from painful menstruation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |