Acupuncture for Non-cyclical Breast Pain

NCT00275574 | Completed

• 1 other identifier: 1975-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Pain

Outcome Measures

Primary Outcomes (1)

• Four acupuncture treatments over a period of two weeks can improve non-cyclical breast pain

  two weeks

Study Arms (1)

acupuncture

EXPERIMENTAL

four acupuncture treatments over a period of two weeks

Procedure: acupuncture

Interventions

acupuncture PROCEDURE

acupuncture

acupuncture

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Mastodynia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lori A. Thicke, R.N., M.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: APRN CNS

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 12, 2006
• Study Start: April 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

US (1)