RecruitingACTRN12610000466044

Evaluation of the effect of transcutaneous electric nerve simulation (TENS) for the treatment of primary dysmenorrhea.

A randomised, double-blind, placebo controlled clinical trial of the effectiveness of high and low frequency transcutaneous electrical nerve stimulation (TENS) on pain intensity in primary dysmenorrhea.

Sponsor

University of Pernambuco

Enrollment

20 participants

Start Date

Mar 1, 2010

Study Type

Interventional

Conditions

Primary Dysmenorrhea

Summary

This is a controlled, double-blind, randomized clinical study that compares three study groups; high-frequency TENS, low-frequency TENS and placebo TENS. The aim of this study will be to determine the effectiveness of high and low frequency transcutaneous electrical nerve stimulation when compared to placebo for treatment of primary dysmenorrhea.

Eligibility

Sex: FemalesMin Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of TENS (transcutaneous electrical nerve stimulation) therapy — high-frequency and low-frequency — against a fake (placebo) TENS device for treating primary dysmenorrhea, which is the medical term for painful menstrual cramps with no underlying medical cause. TENS uses small electrical pulses applied to the skin to block pain signals. Researchers want to find out which, if either, frequency works best for reducing menstrual pain. You may be eligible if: - You are a woman of reproductive age (15 years or older) - You have moderate to severe primary dysmenorrhea (painful periods without an underlying cause) - Your period pain affects more than half of your menstrual cycles You may NOT be eligible if: - Your painful periods are caused by an underlying condition such as endometriosis (secondary dysmenorrhea) - Your pain is caused by an intrauterine device (IUD) - Your period pain is mild or only happens occasionally Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The subjects will assigned randomly to one of 3 groups: 1) TENS High frequency, will receive conventional TENS of 100 Hz, pulse width of 100 microseconds; 2) TENS Low frequency, will receive TENS o

The subjects will assigned randomly to one of 3 groups: 1) TENS High frequency, will receive conventional TENS of 100 Hz, pulse width of 100 microseconds; 2) TENS Low frequency, will receive TENS of 4 Hz, pulse width of 100 microseconds; 3) TENS Placebo. The treatment will be performed in a single session, and the TENS will be applied for 30 minutes. Each subject will notified the investigator upon onset of her pain. The treatment will be administered when the subject notifies investigator that she is experiencing pain during a menstrual cycle or 3 days before the menstruation.The subjects will instructed to take no pain medication for at least six hours before treatment. Two electrodes will placed on the low back area (L3, L4), and the others two over suprapubic area.