Transcutaneous Electrical Nerve Stimulation is a Promising Novel Non-pharmacological Treatment Alternative for Mastalgia: A Randomized Clinical Trial

Ankara University1 site in 1 country93 target enrollmentFebruary 1, 2020

Overview

Brief Summary

The main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus.

Detailed Description

The main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus. This randomized controlled clinical trial was completed with 20 women suffering from mastalgia. Patients were randomly assigned to the TENS treatment and sham application groups. Pain intensity, pain patterns and quality of life were evaluated with Breast Pain and SF-36 questionnaires before and 10 days after treatment in all patients.

Registry

clinicaltrials.gov

Start Date

February 1, 2020

End Date

January 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ankara University

Responsible Party

Principal Investigator

Volkan Genc

MD Professor, Director

Ankara University

Eligibility Criteria

Inclusion Criteria

•Patients with mastalgia between 18 and 70 yrs old

Exclusion Criteria

•Previous or new diagnosis of diseases that may cause extramammary mastalgia (history of previous breast surgery; inflammatory and/or tumoral breast or chest disorders such as mastitis, fibrocystic breasts, breast cancer or chest malignancies etc.)
•Having with conditions that might prevent TENS application (pacemaker, metal prosthesis, epilepsy, etc.)
•Being unable or insufficient to fill the questionnaires.

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Before and 10 days after treatment

The Breast Pain Questionnaire (BPQ), derived from the McGill Pain Questionnaire, was used to assess breast pain intensity. It is a tool that aims to evaluate the severity, pattern, location, duration and frequency of breast pain. It is calculated on the basis of Visual analog scale (VAS) and present pain intensity (PPI) scores in addition to sensory and affective component scores. Regarding the final total BPQ scores, patients' pain severity classified as mild (0-100), moderate (100-200), and severe (\>200)