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

University of Southern California1 site in 1 country44 target enrollmentMarch 1, 2022

ConditionsPrimary Dysmenorrhea

Overview

Phase: N/A
Intervention: Not specified
Conditions: Primary Dysmenorrhea
Sponsor: University of Southern California
Enrollment: 44
Locations: 1
Primary Endpoint: Analgesic effects of TENS on primary dysmenorrhea.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2022

End Date

May 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Southern California

Responsible Party

Principal Investigator

Todd Schroeder

Associate Professor of Clinical Physical Therapy

University of Southern California

Eligibility Criteria

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

Outcomes

Primary Outcomes

Analgesic effects of TENS on primary dysmenorrhea.

Time Frame: 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.