Acupuncture for Non-cyclical Breast Pain

NCT ID: NCT00275574

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-08-31

Brief Summary

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Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast pain can go untreated due to its various etiologies and non-specific presentation. Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a release of endorphins and other chemicals in the central nervous system. Thus, it is thought to help relieve pain. To date, there has been minimal research using acupuncture for breast pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over a period of two weeks will significantly lower the level of pain experienced by these participants. Additionally, we will evaluate quality of life measures.

Detailed Description

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Conditions

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Breast Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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acupuncture

four acupuncture treatments over a period of two weeks

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

acupuncture

Interventions

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acupuncture

acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female
* greater than 18 years
* non-cyclical unilateral or bilateral breast pain occurring daily, Greater than or equal to 2 on the BPI (average pain question)
* pain for more than 3 months
* satisfactory (non-suspicious for malignancy) breast examination within one year of enrollment (need documentation from physician or advanced practice nurse)
* satisfactory (non-suspicious for malignancy) mammogram and/or ultrasound within one year if Greater than 35 years(need written report to verify)
* able to return for acupuncture two times a week for two weeks
* speak and understand English
* hormone replacement therapy discontinued \> 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Lori Thicke

APRN CNS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lori A. Thicke, R.N., M.S.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1975-02

Identifier Type: -

Identifier Source: org_study_id

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