A New Treatment Option for Mastalgia

December 10, 2023 updated by: Volkan Genc, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06450
        • Ankara Universityt School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TENS
Device: TENS
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive treatment method widely used for pain control
Sham Comparator: Sham TENS
Device: TENS
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive treatment method widely used for pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Before and 10 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Before and 10 days after treatment
The Turkish version of the Short Form-36 version 2 (SF-36v2) was used to assess QoL before and 10 days after treatment.
Before and 10 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Aysun Genç, Assoc Prof, Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 10, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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