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

University of Southern California44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Dysmenorrhea

Interventions

One Unit TENSDEVICE

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.

Two Unit TENSDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Southern California Health Sciences Campus Center for Health Professions

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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