NCT02784379

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

May 24, 2016

Last Update Submit

November 26, 2016

Conditions

Keywords

MastalgiaelectromyographyPectoral

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

The breast with mastalgia

Electromyography will be performed to the pectoral muscle that is placed behind the breast with mastalgia.

The breast without mastalgia

Electromyography will be performed to the pectoral muscle that is placed behind the breast without mastalgia.

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

31 patients who has unilateral mastalgia

You may qualify if:

  • Subject has unilateral mastalgia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Etfal Training and Research Hospital

Istanbul, Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Mastodynia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cemal Kaya, M.D.

    Sisli Etfal Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 24, 2016

First Posted

May 27, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations