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

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One Unit TENS
Two Unit TENS
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Southern California Health Sciences Campus Center for Health Professions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

One Unit TENS

Two Unit TENS

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 1, 2021
Last Updated
October 10, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05178589
Brief Title
The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief
Official Title
The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen.
Arm Title
One Unit TENS
Arm Type
Experimental
Arm Description
Participants will use one-unit TENS set-up where the TENS unit has 2 channels.
Arm Title
Two Unit TENS
Arm Type
Experimental
Arm Description
Participants will use a two-unit TENS set-up where the TENS unit has 4 channels.
Intervention Type
Device
Intervention Name(s)
One Unit TENS
Other Intervention Name(s)
PowerDot
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Two Unit TENS
Other Intervention Name(s)
PowerDot
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analgesic effects of TENS on primary dysmenorrhea.
Description
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 Outcome Measure Information:
Title
Change in analgesic pill consumption during menstruation
Description
Participants will be administered a daily survey where they will be asked to record analgesic pill intake throughout the day.
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
The surface area of TENS pain relief
Description
Participants will use either one or 2 unit TENS.
Time Frame
1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All menstruating persons are able to participate.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Blood clots Pregnancy or trying to become pregnant Cancerous lesions Exposed metal implants History of seizures Sensory or mental impairment Unstable fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Schroeder, PhD
Organizational Affiliation
Associated Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California Health Sciences Campus Center for Health Professions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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

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