The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief: A Randomized Control Trial

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Device: One Unit TENS
* Device: Two Unit TENS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen. | |
| Experimental: One Unit TENS<br>Participants will use one-unit TENS set-up where the TENS unit has 2 channels. | Device: One Unit TENS<br>* 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.<br>* Other names: PowerDot;|
| Experimental: Two Unit TENS<br>Participants will use a two-unit TENS set-up where the TENS unit has 4 channels. | Device: Two Unit TENS<br>* 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.<br>* Other names: PowerDot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |