- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02784379
Electromyography of the Pectoral Muscle in Mastalgia Patients
November 26, 2016 updated by: Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
The Comparison Both of the Electromyography Results of the Pectoral Muscle in Unilateral Mastalgia Patients
Mastalgia is a common problem for women.
The aim of this study is to investigate the role of neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.
Study Overview
Status
Completed
Conditions
Detailed Description
Mastalgia is a common health problem for women especially these days.
Studies demonstrated that 48% of the women with mastalgia have serious difficulties in their sexual life, 36% have physical activity difficulties, 13% have social activity difficulties and 6% have work or school activity difficulties.
The etiology of the mastalgia is not clear.
Because of the women with mastalgia tested out lots of examinations for the etiology.
Also this problem has financial load because of the unknown etiology.
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34371
- Sisli Etfal Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
31 patients who has unilateral mastalgia
Description
Inclusion Criteria:
- Subject has unilateral mastalgia
Exclusion Criteria:
- Subject has pregnancy
- Subject has breast cancer
- Subject has a history of breast operation
- Subject has diabetes mellitus
- Subject has 1 cm or above cystic or solid lesions in the breasts.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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The breast with mastalgia
Electromyography will be performed to the pectoral muscle that is placed behind the breast with mastalgia.
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The breast without mastalgia
Electromyography will be performed to the pectoral muscle that is placed behind the breast without mastalgia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Electromyography results of the pectoral muscle.
Time Frame: 5 days
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The electromyography results of the pectoral muscle which are placed behind the healthy breast (group 1) and the breast with mastalgia (group 2) will be evaluated.
The results of the both groups will be compared.
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5 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cemal Kaya, M.D., Sisli Etfal Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kernerman E, Park E. Severe Breast Pain Resolved with Pectoral Muscle Massage. J Hum Lact. 2014 Aug;30(3):287-291. doi: 10.1177/0890334414535842. Epub 2014 May 29.
- Joyce DP, Alamiri J, Lowery AJ, Downey E, Ahmed A, McLaughlin R, Hill AD. Breast clinic referrals: can mastalgia be managed in primary care? Ir J Med Sci. 2014 Dec;183(4):639-42. doi: 10.1007/s11845-013-1066-z. Epub 2014 Jan 9.
- Salzman B, Fleegle S, Tully AS. Common breast problems. Am Fam Physician. 2012 Aug 15;86(4):343-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
May 24, 2016
First Submitted That Met QC Criteria
May 26, 2016
First Posted (Estimate)
May 27, 2016
Study Record Updates
Last Update Posted (Estimate)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 26, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mastalgia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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