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

NCT ID: NCT05178589

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

One Unit TENS

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

Group Type EXPERIMENTAL

One Unit TENS

Intervention Type 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.

Two Unit TENS

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

Group Type EXPERIMENTAL

Two Unit TENS

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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PowerDot PowerDot

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Todd Schroeder

Associate Professor of Clinical Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Todd Schroeder, PhD

Role: PRINCIPAL_INVESTIGATOR

Associated Professor

Locations

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University of Southern California Health Sciences Campus Center for Health Professions

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39066557 (View on PubMed)

Other Identifiers

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HS-21-00629

Identifier Type: -

Identifier Source: org_study_id

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