A New Treatment Option for Mastalgia
Transcutaneous Electrical Nerve Stimulation is a Promising Novel Non-pharmacological Treatment Alternative for Mastalgia: A Randomized Clinical Trial
1 other identifier
interventional
93
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 10, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedDecember 13, 2023
December 1, 2023
9 months
November 10, 2023
December 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of life
Before and 10 days after treatment
Study Arms (2)
TENS
ACTIVE COMPARATORSham TENS
SHAM COMPARATORInterventions
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive treatment method widely used for pain control
Eligibility Criteria
You may qualify if:
- Patients with mastalgia between 18 and 70 yrs old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Universityt School of Medicine
Ankara, 06450, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aysun Genç, Assoc Prof
Ankara University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Professor, Director
Study Record Dates
First Submitted
November 10, 2023
First Posted
December 13, 2023
Study Start
February 1, 2020
Primary Completion
November 1, 2020
Study Completion
January 1, 2023
Last Updated
December 13, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share