A New Treatment Option for Mastalgia

Mastalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06168110
• Other study ID #: 211020
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 1, 2023
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mastalgia
• Mastodynia

Intervention

Device:
• TENS
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive treatment method widely used for pain control

Locations

Country	Name	City	State
Turkey	Ankara Universityt School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	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	Quality of life	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