A New Treatment Option for Mastalgia

Ankara University

Status: Completed

Conditions: Mastalgia

Treatments: Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT06168110

211020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

TENS

Active Comparator group

Treatment:

Device: TENS

Sham TENS

Sham Comparator group

Treatment:

Device: TENS