Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by New York Institute of Technology.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT01643837
First received: July 10, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Mastalgia
Other: Osteopathic Manipulative Treatment
Other: Osteopathic Manipulative Light Touch Protocol (LT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment?

Resource links provided by NLM:


Further study details as provided by New York Institute of Technology:

Primary Outcome Measures:
  • Change from baseline in Severity of Mastalgia [ Time Frame: 30, 60, 90, 120, 210 days ] [ Designated as safety issue: No ]
  • Change from baseline in Duration of Mastalgia [ Time Frame: 30, 60, 90, 120, 210 days ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life [ Time Frame: 30, 60, 90, 120, 210 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 87
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard
Standard treatment follow-up: 1. monthly history 2. monthly clinical breast examination.
Sham Comparator: Light Touch (LT)

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

Light touch protocol.

Other: Osteopathic Manipulative Light Touch Protocol (LT)
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
Experimental: Osteopathic Manipulative Treatment (OMT)

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

OMT Protocol.

Other: Osteopathic Manipulative Treatment
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643837

Contacts
Contact: Sharon L Koehler, DO 516-686-1407 Skoehl01@nyit.edu
Contact: Sonia Rivera-Martinez, DO srmartin@nyit.edu

Locations
United States, New York
Family Health Care Center Not yet recruiting
Central Islip, New York, United States, 11722
Contact: Sharon L Koehler, DO       Skoehl01@nyit.edu   
Academic Health Care Center Not yet recruiting
Old Westbury, New York, United States, 11568
Contact: Sharon L Koehler, DO       Skoehl01@nyit.edu   
Sponsors and Collaborators
New York Institute of Technology
Investigators
Principal Investigator: Sharon L Koehler, DO New York Institute of Technology
  More Information

Publications:
Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT01643837     History of Changes
Other Study ID Numbers: BHS-799
Study First Received: July 10, 2012
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York Institute of Technology:
Mastalgia
Breast Pain
Osteopathic Manipulative Medicine
Osteopathic Manipulative Treatment

ClinicalTrials.gov processed this record on July 24, 2014