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CompletedNCT00275574Updated Jan 1, 2016

Acupuncture for Non-cyclical Breast Pain

An interventional study of acupuncture in Breast Pain, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-01.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Pain

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03

In context

Mastodynia

54 studies on the registry are indexed under Mastodynia; 10 are open to participants now.

This study's enrollment of 30 is below the median of 65 across 42 interventional studies indexed under Mastodynia.

Browse Mastodynia studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    acupuncture

    four acupuncture treatments over a period of two weeks

    Procedure: acupuncture

Interventions

  • Procedureacupuncture

    acupuncture

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What researchers measure

Primary outcomes

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

    Time frame: two weeks

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00275574
Lead sponsor
Mayo Clinic
Responsible party
Lori Thicke (APRN CNS, Mayo Clinic) — Principal investigator
First posted
Jan 12, 2006
Start date
Apr 2003
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Jan 1, 2016

Study contacts

Lori A. Thicke, R.N., M.S.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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