Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment

Our objective is to evaluate the effectiveness of osteopathic manipulative treatment (OMT)
as compared to a light touch protocol and standard management in the treatment of women with
cyclical and non-cyclical mastalgia (breast pain).

A randomized placebo controlled study will be conducted at two academic health care centers.
Women with breast pain will be evaluated and followed by the breast surgeon. Once a
pathologic cause has been ruled out, the women will be stratified and randomly divided into
three study groups. Group A, B, and C. Group A will receive standard of care treatment.
Group B will receive light touch (a placebo for the OMT treatment). Group C will receive OMT
directed at treating mastalgia. The treatment will continue for three months.

The subjects will fill out an initial pain questionnaire and a follow-up questionnaire each
month. They will also be instructed to fill out a breast pain log daily for three months. A
final questionnaire will be completed at six months. Statistical analysis will be utilized
to determine whether the addition of OMT improves the severity or duration of the pain as
well as quality of life as assessed by the patient.

Inclusion Criteria:

- Women over 18 years of age presenting with breast pain, both cyclical and
noncyclical, who complain of pain despite a negative full work-up for pathology,
reassurance, and use of an appropriate supportive bra.

- A pain scale questionnaire will be completed by the subject. The pain should be
present for at least 7 days each month if it is mild pain or be of moderate to severe
intensity for at least 3 days each month. In addition, breast pain must have been
present for a minimum of 2 consecutive months preceding the date of inclusion into
the study.

Exclusion Criteria:

- Women under 18 years old, women who have had recent breast surgery (<2yrs), women who
have breast implants.

- Women with bleeding risk such as those regularly taking aspirin, NSAIDs, Plavix or
any other anticoagulation therapy.

- Women who are pregnant, breastfeeding or who are planning to get pregnant are
excluded.

- Women with known chronic pain syndromes or structural abnormality such as
osteoporosis will be excluded. When necessary bone densitometry will be performed.

- Women who are unable to complete the questionnaire.