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

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

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 Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Device: One Unit TENS; Device: Two Unit TENS

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Todd Schroeder, PhD; Phone Number: ‭(626) 372-1890‬; Email: eschroed@pt.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California Health Sciences Campus Center for Health Professions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The surface area of TENS pain relief	Participants will use either one or 2 unit TENS.	1 month

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Todd Schroeder, PhD, Associated Professor

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: HS-21-00629

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes