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

NCT05178589 | Completed FDA Device

• 1 other identifier: HS-21-00629
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in analgesic pill consumption during menstruation

  1 month

Other Outcomes (1)

• The surface area of TENS pain relief

  1 month

Study Arms (3)

Control

NO INTERVENTION

During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen.

One Unit TENS

EXPERIMENTAL

Participants will use one-unit TENS set-up where the TENS unit has 2 channels.

Device: One Unit TENS

Two Unit TENS

EXPERIMENTAL

Participants will use a two-unit TENS set-up where the TENS unit has 4 channels.

Device: Two Unit TENS

Interventions

One Unit TENS DEVICE

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.

Also known as: PowerDot

One Unit TENS

Two Unit TENS DEVICE

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.

Also known as: PowerDot

Two Unit TENS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: All menstruating persons are able to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California Health Sciences Campus Center for Health Professions

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• McLagan B, Dexheimer J, Strock N, Goldstein S, Guzman S, Erceg D, Schroeder ET. The role of transcutaneous electrical nerve stimulation for menstrual pain relief: A randomized control trial. Womens Health (Lond). 2024 Jan-Dec;20:17455057241266455. doi: 10.1177/17455057241266455.

  PMID: 39066557 DERIVED

Study Officials

• Todd Schroeder, PhD

  Associated Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 5, 2022
• Study Start: March 1, 2022
• Primary Completion: April 27, 2023
• Study Completion: May 1, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

US (1)