Primary Dysmenorrhea
Conditions
Brief summary
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.
Interventions
DEVICEOne 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.
DEVICETwo 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. 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.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* History of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year * BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths * Not taking contraception or other types of medication that could influence reproductive status * Regular menstruation * Medically free from chronic diseases * Free from known gynecological problems (ie. Endometriosis, Fibroids, Ovarian Cysts) * History of analgesic pill intake during menstruation * No pelvic pathology
Exclusion criteria
* Amenorrhea * On a form of contraception * Secondary dysmenorrhea and/or other gynecological problems that may cause pain * No discomfort, pain, or other symptoms during menstruation * History of surgery over lower abdomen area * Allergy to ibuprofen * Cardiac disability * Pacemaker * Arterial disease * Uncontrolled hemorrhage * Blood clots * Pregnancy or trying to become pregnant * Cancerous lesions * Exposed metal implants * History of seizures * Sensory or mental impairment * Unstable fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic effects of TENS on primary dysmenorrhea. | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in analgesic pill consumption during menstruation | 1 month | Participants will be administered a daily survey where they will be asked to record analgesic pill intake throughout the day. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The surface area of TENS pain relief | 1 month | Participants will use either one or 2 unit TENS. |
Countries
United States
Outcome results
None listed