An interventional study of One Unit TENS and Two Unit TENS in Primary Dysmenorrhea, sponsored by University of Southern California. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen.
Participants will use one-unit TENS set-up where the TENS unit has 2 channels.
Device: One Unit TENS
Participants will use a two-unit TENS set-up where the TENS unit has 4 channels.
Device: Two Unit TENS
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.
Also known as: PowerDot
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.
Also known as: PowerDot
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.
Time frame: 1 month
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.
Time frame: 1 month
The surface area of TENS pain relief
Participants will use either one or 2 unit TENS.
Time frame: 1 month
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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University of Southern California