Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment

New York Institute of Technology

Status: Withdrawn

Conditions: Mastalgia

Treatments: Other: Osteopathic Manipulative Treatment; Other: Osteopathic Manipulative Light Touch Protocol (LT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01643837

BHS-799

Details and patient eligibility

About

There are many current medical treatments for mastalgia, but few have been proven effective. Our objective is to evaluate the effectiveness of osteopathic manipulative treatment as compared to a light touch protocol and standard management in the treatment of women with cyclical and non-cyclical mastalgia. We will compare duration of the pain, severity of the pain and the effect of the pain on quality of life.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Standard

No Intervention group

Description:

Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination.

Light Touch (LT)

Sham Comparator group

Description:

Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. Light touch protocol.

Treatment:

Other: Osteopathic Manipulative Light Touch Protocol (LT)

Osteopathic Manipulative Treatment (OMT)

Experimental group

Description:

Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. OMT Protocol.

Treatment:

Other: Osteopathic Manipulative Treatment