A New Treatment Option for Mastalgia

Not Applicable

Completed

• Conditions: Mastalgia
• Interventions: Device: TENS

• Registration Number: NCT06168110
• Lead Sponsor: Ankara University

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-11-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-11-10
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-10
• Last Update Submitted: 2023-12-10
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TENS	TENS	-
TENS	TENS	-

Primary Outcome Measures

Name	Time	Method
Pain intensity	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)

Secondary Outcome Measures

Name	Time	Method
Quality of life	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.

Trial Locations

Locations (1)

Ankara Universityt School of Medicine; 🇹🇷 Ankara, Turkey