MastalgiaNCT02784379
Electromyography of the Pectoral Muscle in Mastalgia Patients
An observational study of Mastalgia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mastalgia
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 31 patients who has unilateral mastalgia
Who may be able to join
- Subject has unilateral mastalgia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Etfal Training and Research Hospital
Istanbul, Istanbul, 34371
About this study
Official title: 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.
Read the 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.
- Conditions
- Mastalgia
- Keywords
- Mastalgia, electromyography, Pectoral
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MastalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Cemal Kaya, M.D., Principal investigator, Sisli Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784379
- Sponsor's protocol ID
- Mastalgia
- Status last verified
- Nov 2016
- First submitted
- 24 May 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 24874898Joyce 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.
PubMed 24402166Salzman B, Fleegle S, Tully AS. Common breast problems. Am Fam Physician. 2012 Aug 15;86(4):343-9.
PubMed 22963023
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Both of the Electromyography Results of the Pectoral Muscle in Unilateral Mastalgia Patients
- ClinicalTrials.gov ID
- NCT02784379
- Acronym / sponsor ID
- Mastalgia
- Conditions
- Mastalgia
- Keywords
- Mastalgia, electromyography, Pectoral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 31 patients who has unilateral mastalgia
Key inclusion criteria (1 listed)
- Subject has unilateral mastalgia
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electromyography results of the pectoral muscle.
Time frame: 5 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Results publication: PubMed 24874898Kernerman 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.
- Results publication: PubMed 24402166Joyce 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.
- Results publication: PubMed 22963023Salzman B, Fleegle S, Tully AS. Common breast problems. Am Fam Physician. 2012 Aug 15;86(4):343-9.
- Individual participant dataSharing planned: Undecided
Related trials for Mastalgia
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Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
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ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemal Kaya, M.D. principal investigator
Sisli Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastalgia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography results of the pectoral muscle. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784379, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.