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Completed

NCT Number: NCT05178589

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

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.

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Key information

Conditions

Primary Dysmenorrhea

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California Health Sciences Campus Center for Health Professions

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PowerDot

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.

Other names: PowerDot

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in analgesic pill consumption during menstruation

    Time frame: 1 month

    Participants will be administered a daily survey where they will be asked to record analgesic pill intake throughout the day.

Other outcomes

  1. The surface area of TENS pain relief

    Time frame: 1 month

    Participants will use either one or 2 unit TENS.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2022
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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