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

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Device: One Unit TENS; Device: Two Unit TENS

• Registration Number: NCT05178589
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-05
• Study Start: 2022-03-01
• Primary Completion: 2023-04-27
• Study Completion: 2023-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One Unit TENS	One Unit TENS	Participants will use one-unit TENS set-up where the TENS unit has 2 channels.
Two Unit TENS	Two Unit TENS	Participants will use a two-unit TENS set-up where the TENS unit has 4 channels.

Primary Outcome Measures

Name	Time	Method
Analgesic effects of TENS on primary dysmenorrhea.	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 Outcome Measures

Name	Time	Method
Change in analgesic pill consumption during menstruation	1 month	Participants will be administered a daily survey where they will be asked to record analgesic pill intake throughout the day.

Trial Locations

Locations (1)

University of Southern California Health Sciences Campus Center for Health Professions; 🇺🇸 Los Angeles, California, United States