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A New Treatment Option for Mastalgia

NCT ID: NCT06168110

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Mastalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TENS

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

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

Sham TENS

Group Type SHAM_COMPARATOR

TENS

Intervention Type DEVICE

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

Interventions

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TENS

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Volkan Genc

MD Professor, Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysun Genç, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Ankara Universityt School of Medicine

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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211020

Identifier Type: -

Identifier Source: org_study_id