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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02784379
Other study ID # Mastalgia
Secondary ID
Status Completed
Phase N/A
First received May 24, 2016
Last updated November 26, 2016
Start date March 2016
Est. completion date November 2016

Study information

Verified date November 2016
Source Sisli Etfal Training & Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date November 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Sisli Etfal Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sisli Etfal Training & Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Kernerman E, Park E. Severe Breast Pain Resolved with Pectoral Muscle Massage. J Hum Lact. 2014 May 29;30(3):287-291. [Epub ahead of print] — View Citation

Salzman B, Fleegle S, Tully AS. Common breast problems. Am Fam Physician. 2012 Aug 15;86(4):343-9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Electromyography results of the pectoral muscle. 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. 5 days No
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