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The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen. | |
| One Unit TENS | Experimental | Participants will use one-unit TENS set-up where the TENS unit has 2 channels. |
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| Two Unit TENS | Experimental | Participants will use a two-unit TENS set-up where the TENS unit has 4 channels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One Unit TENS | Device | TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Single unit TENS was administered via 2 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic effects of TENS on primary dysmenorrhea. | To determine whether TENS will reduce pain symptoms in those with primary dysmenorrhea. Subjective pain will be assessed using an 11 point visual analog scale (VAS). The scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in analgesic pill consumption during menstruation | Participants will be administered a daily survey where they will be asked to record analgesic pill intake throughout the day. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The surface area of TENS pain relief | Participants will use either one or 2 unit TENS. | 1 month |
Inclusion Criteria:
Exclusion Criteria:
All menstruating persons are able to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Schroeder, PhD | Associated Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California Health Sciences Campus Center for Health Professions | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39066557 | Derived | McLagan B, Dexheimer J, Strock N, Goldstein S, Guzman S, Erceg D, Schroeder ET. The role of transcutaneous electrical nerve stimulation for menstrual pain relief: A randomized control trial. Womens Health (Lond). 2024 Jan-Dec;20:17455057241266455. doi: 10.1177/17455057241266455. |
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This is a randomized cross-over design over the course of 3 menstrual cycles. Each menstruation phase begins on the first day of menstruation until the last day of menstruation (disappearance of bleeding). Each participant will participate in 3 randomized conditions: control (no TENS), one-unit TENS, and two-unit TENS.
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| Two Unit TENS | Device | TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Double unit TENS was administered via 4 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day. |
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