Breast PainNCT00275574
Acupuncture for Non-cyclical Breast Pain
A study testing acupuncture in people with Breast Pain, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Pain
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 2009
- Phase
- Interventional
- 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 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture for the Treatment of Non-Cyclical Breast Pain
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
- Being tested
- acupuncture
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
acupuncture
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | four acupuncture treatments over a period of two weeks Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four acupuncture treatments over a period of two weeks can improve non-cyclical breast pain
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startApr 2003
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Thicke, Mayo Clinic
- Investigators
- Lori A. Thicke, R.N., M.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275574
- Sponsor's protocol ID
- 1975-02
- Status last verified
- Dec 2015
- First submitted
- 10 Jan 2006
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Non-Cyclical Breast Pain
- ClinicalTrials.gov ID
- NCT00275574
- Acronym / sponsor ID
- 1975-02
- Conditions
- Breast Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Jan 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Procedure: acupuncturefour acupuncture treatments over a period of two weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureacupuncture | Procedure or surgery | acupuncture |
Primary outcome
Four acupuncture treatments over a period of two weeks can improve non-cyclical breast pain
Time frame: two weeks
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 1 Jan 2016.
Related trials for Breast Pain
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Not yet recruiting
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
Post-mastectomy Pain Syndrome
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
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.
Lori A. Thicke, R.N., M.S. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Breast Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Jan 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 United States. 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?
Four acupuncture treatments over a period of two weeks can improve non-cyclical breast pain (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2016.