Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment?

Conditions
-----------------
Mastalgia

Intervention / Treatment
-----------------
* Other: Osteopathic Manipulative Treatment
* Other: Osteopathic Manipulative Light Touch Protocol (LT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. | |
| Sham Comparator: Light Touch (LT)<br>Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. Light touch protocol. | Other: Osteopathic Manipulative Light Touch Protocol (LT)<br>* LT - Sacral Region; LT - Lumbar Spine and Lower Thoracic Region; LT - Upper Thoracic Spine Region; LT - Cervical Spine Region; LT - Suboccipital Region; LT - Clavicles; LT - First Ribs; LT - Ribs 2-8; LT - Pectoralis Muscles; LT - Sternum; LT - Respiratory Diaphragm; LT - Upper Thoracic Cage; LT - Lower Thoracic Cage<br>|
| Experimental: Osteopathic Manipulative Treatment (OMT)<br>Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination. OMT Protocol. | Other: Osteopathic Manipulative Treatment<br>* OMT - Sacral Ligamenotus Articular Release; OMT - Lumbar Spine (L1-L2) and Lower Thoracic Spine (T10-12) Ligamentous Articular Release; OMT - Upper Thoracic Spine Ligamentous Articular Release (T1-T8); OMT - Cervical Spine Ligamentous Articular Release (C5-C7); OMT - Suboccipital Myofascial Release; OMT - Clavicular Ligamentous Articular Release; OMT - First Rib Ligamentous Articular Release; OMT - Ribs 2-8 Ligamentous Articular Release; OMT - Pectoral Pull; OMT - Sternal Ligamentous Articular Release; OMT - Direct Myofascial Release of the Diaphragm; OMT - Thoracic Lymphatic Pump; OMT - Fascial Release of Breast Tissue<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Severity of Mastalgia |  | 30, 60, 90, 120, 210 days | 
| Change from baseline in Duration of Mastalgia |  | 30, 60, 90, 120, 210 days | 
| Change from baseline in Quality of Life |  | 30, 60, 90, 120, 210 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mastalgia, Breast Pain, Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment