Clinical Trial: Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment?
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 Summary:
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.
Sponsor: New York Institute of Technology
Current Primary Outcome:
- Change from baseline in Severity of Mastalgia [ Time Frame: 30, 60, 90, 120, 210 days ]
- Change from baseline in Duration of Mastalgia [ Time Frame: 30, 60, 90, 120, 210 days ]
- Change from baseline in Quality of Life [ Time Frame: 30, 60, 90, 120, 210 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: New York Institute of Technology
Dates:
Date Received: July 10, 2012
Date Started: February 2016
Date Completion: June 2016
Last Updated: January 19, 2016
Last Verified: January 2016
